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Amazon Prime Day fitness deals: the best offers on watches, treadmills and more – TechRadar

Posted: June 22, 2021 at 1:53 am


We've seen a huge array of fitness equipment in this year's Prime Day deals, including big savings on top brands like Garmin, Fitbit and XIaomi.

Fitness trackers and smartwatches make up the bulk of this year's deals, so if you've been thinking of investing in a new sports watch then this is the perfect time. Most of these devices are at their cheapest prices ever, and we don't expect they'll drop this low again until Black Friday (perhaps not even then).

We've also found some great offers on other fitness equipment, including treadmills and running headphones, and we'll be keeping a close eye out for new deals throughout the rest of Prime Day so you don't miss a thing.

Garmin Approach S40: $239.79 $189.99 at AmazonSave $49.80 A powerful golf watch to help perfect your performance on the course, the Approach S40 has never been this cheap before, even on Black Friday, making it excellent value on Prime Day. It's almost as feature-packed as the far more expensive S42, and will be a solid investment.View Deal

Garmin Approach G10: $99.99 $79.99 at AmazonSave $20 A gold watch isn't always the best tool for tracking your game and navigating the course, and this neat little GPS unit and digital scorecard can fit easily on your belt or in your hand. It's not dropped below $90 at Amazon before, so this is a modest but worthwhile saving.View Deal

Garmin Fenix 6 Sapphire: $579.99 $499.99 at AmazonSave $80 A premium edition of Garmin's top-end running watch, topped with sapphire crystal. It's very rare to see top-end Fenix 6 models hit $500, and this particular variant currently costs $649.99 if you buy it directly from Garmin. If you've been holding out for a deal on a top-end Garmin, this is it.View Deal

Garmin Venu: $269.89 $219.99 at AmazonSave $50 The Venu is one of Garmin's most striking smartwatches, thanks to its vivid AMOLED screen. The newer Venu 2 offers a couple more features, but this is still a top-notch device. It's been hovering around the $260 mark all year so far, and this Prime Day offer is the best genuine deal we've seen.View Deal

Garmin Venu Sq Music: $199.99 $189.99 at AmazonSave $10 One of Garmin's most fashionable watches, the Venu Sq Music is compact but packed with health and workout tools. It was already a good deal at the original price, at $50 off the RRP, and this offer doesn't knock much more off, but it's still cheaper than you'll find anywhere else.View Deal

Garmin Vivoactive 4: $269.99 $189.99 at AmazonSave $80 We're fans of the Vivoactive 4 smartwatch at TechRadar, so it's good to see such a big discount on it for Prime Day. This gray and silver model hit $219.99 just before Christmas, but this is the first time it's ever dipped below the $200 mark.View Deal

Garmin Vivofit Jr 3: $79.99 $49.99 at AmazonSave $30 The Vivofit Jr 3 is a fitness tracker for kids, built to take on the Fitbit Ace. Its regular asking price is pretty steep for a children's watch, but with this Prime Day deal, it's a lot easier to justify as a way to get the little ones more active.View Deal

Garmin Instinct Esports Edition: $299.99 $179.99 at AmazonSave $120 This is a special edition of the super-tough Garmin Instinct that lets you broadcast your heart rate and stress level while you stream games, but even if you don't use that feature it's still a superb sports watch - particularly with $120 off.View Deal

Garmin Instinct Tactical Edition: $299.99 $179.99 at AmazonSave $113 If you thought the regular Instinct was tough, this watch goes one further, built to military standards and in a range of earthy colorways. It's never been this cheap before, so sneak up and grab one while Prime Day lasts.View Deal

Amazon Halo: $99.99 $69.99 at AmazonSave $30 Amazon's screenless fitness tracker monitors is gaining new features all the time, and should be a great investment, particularly at this price. It was slightly cheaper on Black Friday 2020, but if you missed out then, this Prime Day deal is the next best thing.View Deal

Fitbit Sense: $249.95 $199.95 at AmazonSave $50 We were hoping for a good deal on Fitbit's top-end smartwatch, and Amazon has delivered. The Sense typically hovers around $280 these days, so this is a very nice saving. If you've been thinking about splurging on the Versa 3, this is a great opportunity to upgrade to the next model up.View Deal

Fitbit Inspire 2: $98.95 $59.99 at AmazonSave 38.96 This is a huge saving on Fitbit's super-slim fitness tracker. It very briefly dropped to the same price just before Christmas, but that deal only lasted a day so this is another opportunity to snap it up super cheap.View Deal

Fitbit Ace 2: $59.19 $29.99 at AmazonSave $29.20 Fitbit has just launched a new version of its kids' fitness tracker, the Fitbit Ace 3, but the Ace 2 is still an excellent way to encourage your kids to get more active. It's almost half price for Prime Day, and we've not seen it drop below $40 before.View Deal

Fitbit Versa 2: 147 119 at AmazonSave 28 Looking for a cheap Fitbit deal? The Fitbit Versa 2 usually hovers around the 140 mark on Amazon, and we've not seen it lower than 129 before, so this is a deal well worth snapping up. It's not the latest model (that would be the considerably more expensive Versa 3) but it's still a great buy.View Deal

Withings Scanwatch: 275 225.47 at AmazonSave 49.53 When we reviewed this hybrid smartwatch last year, we were particularly impressed by its fitness features and classic design, but a little put of by its price. That's no longer an issue, as it's now even cheaper than it was on Black Friday.View Deal

Withings Steel HR: 169.95 118.95 at AmazonSave 51 This is a solid deal on a stylish hybrid fitness tracker, with essential health stats on a mini LCD screen set into its analog face. It dropped slightly lower than this back in 2019, but it's not been that cheap since.View Deal

Withings Steel HR Sport: 142.98 117.23 at AmazonSave 25.75 This special edition of Withings' smart hybrid fitness tracker can monitor 30 activities, estimate VO2 max, monitor sleep, and track day and overnight heart rate. Like the regular Withings Steel HR, its price dropped a little lower than this in June 2019, but only very briefly.View Deal

Xiaomi Mi Smart Band 6: 39.99 27.99 at AmazonSave 12 This little fitness tracker was already great value, and this Prime Day deal makes it super cheap. Despite that, it's genuinely a great device (we were impressed in our tests) and a good alternative to a Fitbit at a fraction of the price.View Deal

Xiaomi Mi Smart Watch Lite: 54.18 41.29 at AmazonSave 12.89 More of a fitness tracker than a smartwatch, but a very good one for the price, with 11 workout modes, sleep tracking, stress monitoring, and even GPS, which is almost unheard of at this price bracket. It's well made, too. A real bargain.View Deal

Polar Unite: 116 89.99 at AmazonSave 26.01 The Unite is Polar's entry-level fitness watch, and would be a great step up from a Fitbit if you're starting to take your workouts more seriously. We've not seen it below 98 before, and this price makes it even more beginner-friendly.View Deal

TicWatch Pro S: 222.99 143.19 at AmazonSave 79.80 The TicWatch Pro S was only released a few months ago, and this is a huge price cut. It's a good-looking smartwatch running Google Wear OS with a good collection of fitness apps. If the superb TicWatch Pro 3 is a little beyond your budget, it's definitely worth your consideration.View Deal

TicWatch Pro 3: 289.99 195.36 at AmazonSave 94.63 This is one of the best Wear OS smartwatches we've tested, and it's never been below 200 before. It's big and bright, with a fast Snapdragon 4100 chipset, high resolution display and three-day battery life. This is the GPS version, but there's also an LTE/4G version available for a little more.View Deal

TicWatch Pro 3 LTE: 329.99 230.99 at AmazonSave 99 This is a huge saving on the superb TicWatch Pro 3 with cellular connectivity courtesy of Vodafone. Its previous lowest price was 280 back in May, and it usually costs around 300, so this is a pretty spectacular Prime Day deal.View Deal

TicWatch Pro 4G/LTE: 167.49 133.99 at AmazonSave 33.50 The TicWatch Pro was first released in 2018, and has stood the test of time well, thanks to its smart dual-layer screen, premium design, and good use of Wear OS. When we first reviewed it, we called it "the best watch you've never heard of", and now the 4G version is its lowest ever price.View Deal

TicWatch GTH: 69.99 55.99 at AmazonSave 14 The TicWatch GTH launched earlier this year, and was super affordable even at full price. It's definitely more of a fitness tracker than a smartwatch (no downloadable apps or music streaming here), but if you're on a super tight budget then the extra 14 off for Prime Day makes it worth a look.View Deal

Wahoo Tickr Fit: 62.43 47.10 at AmazonSave 15.33 This heart rate monitor is one of the best alternatives to a chest strap. It fits around your arm rather than your wrist, so the signal isn't disturbed by gripping motions. It hit 60 in February, but has never been this cheap before.View Deal

Garmin Forerunner 45: 159.99 105 at AmazonSave 54.99 The Forerunner 45 is one of Garmin's entry-level running watches, and is back to its Black Friday price for Prime Day. It usually hovers somewhere around the 140 mark, so this is a great deal if you're getting serious about running and looking to make the step up from a Fitbit.View Deal

Garmin Fenix 6 Pro: 599 374 at AmazonSave 224.99 If you've been looking for a hot Prime Day deal on Garmin's top-end smartwatch, this is it. It's rare to see the Fenix 6 Pro drop below 400, and this is well, well below. Amazon usually charges around 480 for this watch, and we don't expect it to drop this low again until Black Friday.

Garmin Venu: 329.99 225 at AmazonSave 104.99 The Venu is one of Garmin's most striking smartwatches, thanks to its vivid AMOLED screen. The newer Venu 2 offers a couple more features, but this is still a top-notch device. It's been hovering around the 300 mark all year so far, so this is a real saving.View Deal

Garmin Approach S10: 139.99 89 at AmazonSave 50.99 The Approach S10 is Garmin's entry-level golf watch, and at under 90 it's a steal for Prime Day. Sure, it's not the flashiest, but it's got all the essential features you need on the course, and it's back to its Black Friday price right now.View Deal

ProForm Power Series Treadmill: 1,199 719 at AmazonSave 480 We were hoping to see a good deal on a high quality treadmill for Prime Day, and here it is. ProForm is a good, reputable brand and this machine has good specs, including a decent sized running belt and respectable top speed.View Deal

Aftershokz OpenMove: 79.95 63.96 at AmazonSave 15.99 We rarely see Aftershokz headphones in the sales at Amazon or anywhere else so this is a great opportunity to pick up the entry-level set for a bargain price. The OpenMove haven't had a price cut since their launch in September 2020, and may not get another discount before Black Friday.View Deal

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Amazon Prime Day fitness deals: the best offers on watches, treadmills and more - TechRadar

UMF announces director of Athletics, Fitness and Recreation, to retire after long, successful career – Bangor Daily News

Posted: at 1:53 am


FARMINGTON The University of Maine at Farmington has announced that following a long, successful career leading UMF Athletics, Julie Davis, UMF director of Athletics, Fitness and Recreation, will be retiring, effective, June 25.

Farmington has been so fortunate to have Julie at the helm of our Athletics, Fitness and Recreation endeavors for over two decades, said Edward Serna, UMF president. Under her leadership, our Division III athletic programs have expanded, thrived and inspired. New sports-related academic offerings have been developed, and outdoor recreation has become a signature program. We will miss her energy and dedication and wish her all the best in the future.

UMFsstrong competitive tradition in NCAA Division III athletics has been led by Davis since 2000, including 19 conferencechampionships in theNorth Atlantic Conferenceand more in the preceding Maine Athletic Conference/Sunrise and the Reynolds division for alpine ski. Many regional championship appearances and national championship berths for the NCAA and USCSA programs were also garnered.

The NAC will miss Julie tremendously. She is our voice of reason, a voice of our history, and a strong moral compass. She is thoughtful and reasoned. Her impact on the conference is long-standing. Julie just makes the NAC better, said Marcella Zalot, commissioner, North Atlantic Conference. On a personal note, I will miss her friendship, her sound advice and her wisdom. Julie has given so much of herself to the conference and to others. I am excited she can now take some time for herself. She is one of the most exceptional administrators and exceptional people with whom I have had the good fortune to work.

During her tenure,the quantity and quality of programs has expanded, participation has increased, and facilities have seen numerous upgrades, renovations, and expansion. NCAA sport offerings increased from nine to fifteen, and competitive snowsports were reintroduced, more than doubling student athlete participation. This growth and development has extended beyond Athletics to Fitness and Recreation, Mainely Outdoors, the Alpine Operations Certificate, the Coaching Minor and PHE (First Year Physical Activity Program).

Juliehas directed the Department of Athletics with the utmost integrity and heartfelt passion, while always putting the needs of UMF student athletes and her staff first. Every decision Julie made was geared toward enriching the student athlete experience during their time at UMF. She has been a dedicated advocate for the entire campus and I wish her all the best, said Cyndi Pratt, assistant athletics director and head field hockey coach.

Davis was instrumental in increasing alumni engagement by way of participation in alumni games, events and giving. Notably the Leib Field and Len MacPhee Court campaigns resulted in significant enhancements, including the establishment of a state of the art varsity weight room and health and performance strength and conditioning program. The campaign for the Dick Meader Hall of Fame room is underway and has exceeded the original funding goal.

Julie is a champion and an advocate on our campus for the holistic development of all of our students. She is committed to an environment of equity, inclusion and diversity, said Jamie Beaudoin, UMF associate athletics director, womens basketball coach and instructor. She is the driving force in our continued development in moving our department forward. We have been fortunate to have her for all of these years, and I am lucky to have had her as a mentor, a teammate and a friend.

Throughout her time at UMF, academic achievement and community engagement became trademarks of the program. Farmington has routinely been the leader in the number/percentage of student athletes earning scholar athlete accolades. The average student athlete GPA has been above a 3.0, several teams have been ranked high nationally for their team GPA, and three alumni earned NCAA postgraduate scholarships. The most recent student athlete graduation rate was 80%, a high mark for a public University. Beyond the classroom, student athletes have engaged in more than 800 hours of community service in a given year.

I am proud that my advocacy and efforts resulted in increased opportunities for students that positively impacted their experience in ways I trust will help them be more healthy and successful in life beyond UMF. This is true in both athletics and fitness and recreation. It has been a pleasure to work with the staff to build a positive and strong student centered culture, striving for excellence in competition and in character, said Davis. Furthermore, Im appreciative of the teamwork with colleagues across campus, and the support of leadership, alumni and partners in the community. I know that progress and accomplishments attributed to my leadership are the result of teamwork and collaboration. I am so appreciative of the people, the community and the opportunity.

In an occupation where the only constant is change, Julie has always put her staff first, caring about them as people and not just as employees. She consistently advocated for healthy work-life balances in professions known for burn-out, and was generous with praise and encouragement in favorable and challenging times. Perhaps most of all, her focus on inclusivity, equity, and belonging will be a model for our department in the years to come, said Molly Wilkie, UMF head womens soccer coach.

In 2010, Davis was awarded the National NCAA Division III Administrator of the Year Award from Women Leaders in College Sports. She has continued to serve in a leadership role at the conference, regional and national level. At UMF she has served on numerous leadership committees. Most recently she was recognized with the 2019 distinguished staff Above and Beyond Award, nominated by staff, for her contributions to the UMF community.

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UMF announces director of Athletics, Fitness and Recreation, to retire after long, successful career - Bangor Daily News

Teledyne, Planet Fitness, General Motors, Ford and Tesla highlighted as Zacks Bull and Bear of the Day – Yahoo Finance

Posted: at 1:53 am


For Immediate Release

Chicago, IL June 21, 2021 Zacks Equity Research Shares of Teledyne Technologies Incorporated TDY as the Bull of the Day, Planet Fitness, Inc. PLNT as the Bear of the Day. In addition, Zacks Equity Research provides analysis on General Motors Company GM, Ford Motor Company F and Tesla, Inc. TSLA.

Here is a synopsis of all five stocks:

Teledyne Technologies is an excellent inflation play following the sizable increase in inflationary expectations from the FOMC's post-meeting projections. TDY's relative buoyancy amid last week's selloff reaffirms my confidence in this stock as a robust cyclical name to hold for the remainder of 2021. Analysts are increasingly optimistic about this stock, raising their near and long-term EPS estimates and driving TDY into a Zacks Rank #1 (Strong Buy).

Teledyne's vast array of cutting-edge tech-driven products are utilized in critical industrial growth markets that heavily rely on its products. This allows the company to easily pass on their price increases to their end markets with little to no margin deterioration.

TDY is an under-the-radar inflation play that hasn't gained the market traction that I believe it deserves. You can see this from both its lack of analyst coverage and relatively low daily market volume. Nevertheless, TDY is trading around its 50-day moving average (utilizing it as both a support and resistance), riding higher for the past month, heading towards my Fibonacci-derived price target of $495 (over 16% upside).

Teledyne just closed an enormous synergy driving acquisition of FLIR Systems last month. These businesses have complementary product offerings in proprietary sensor technology that will provide immediate value to the combined enterprise.

TDY investors were initially wary of this acquisition when announced on the first trading day of 2021 trading because of the 40% premium they offered for FLIR shares, catalyzing an immediate 7.5% pullback. However, it only took just over a week of trading for the stock to recover as investors saw the robust value proposition in this acquisition.

Story continues

FLIR continues to get awarded lucrative government contracts that drive revenue growth and visibility. The business keeps adding to its backlog of government contracts that range from the Pentagon to the French Defense Procurement Agency. Last month the company announced in a press release that it had "received more than $70 million in new orders for its advanced ground robots from the U.S. Armed Services."

Teledyne is a high-growth industrial business categorized under aerospace & defense equipment in the Zacks database, but the company is so much more than that. According to the company website, Teledyne's end markets include "aerospace and defense, factory automation, air & water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging, and pharmaceutical research." Industries that are all at the forefront of this 4th Industrial Revolution, which is just commencing.

The company has demonstrated excellent operational management with robust growth that is just beginning to accelerate. Teledyne is expected to illustrate top and bottom-line growth of 44.2% & 21.4% this year followed by 23.6% & 18.6% in 2022, respectively. The margin expansion that this enterprise has been able to illustrate continues to impress analysts, with this past quarter demonstrating record operational margin.

All 4 of the covering sell-side analysts on the ZRS platform call it a buy today, and I couldn't agree more. In addition, TDY's most recent sell-side company report illustrated an extremely bullish call from a very reputable firm of $520 a share (over 22% upside).

Every quarter it seems analysts are raising their price targets on persistent earnings beats. Now that military powerhouse FLIR Systems is in the business mix, I expect the company will continue to impress.

Summer is finally here, and the world is ready to show off that beach bod that they have been working so hard for, but unfortunately, that hard work isn't being reaped by the discount gym chain Planet Fitness. After a series of 5 consecutive quarterly misses, sell-side analysts are beginning to lose faith in PLNT, and at its excessively rich valuation multiple, I wouldn't touch the stock.

Analysts are getting increasingly uninspired by this "Judgement Free Zone" gym's narrative and have been dropping their EPS estimates for the next couple of years, pulling this stock down to a Zacks Rank #5 (Strong Sell).

Planet Fitness had been one of the fastest-growing gyms in the pre-pandemic US economy, but like most gyms, it couldn't retain its peak pre-COVID customer base of 15.5 million, which it had reach by the end of Q1 2020. As a result, in only one year of operation, this budget gym has lost 1.4 million members (having 14.1 million members as of March 31, 2021) and has been struggling to get consumers back in its gyms, despite opening up over 100 new locations (5% increase in gym locations, and 9% decline in memberships). This business may be over-extending itself.

We all know Planet Fitness as the inexpensive purple gym meant for individuals who don't take working out too seriously. One of its unique gimmicks is its "Lunk Alarm" that goes off and draws attention to anyone that is lifting "too hard," aka grunting or dropping weights. But, unfortunately, the pandemic has changed consumers' perspectives on the $10 a month health club membership.

It would appear that this pandemic and the global lockdowns have changed society's perception of living a "healthy lifestyle," and being a member of a gym doesn't seem to be at the top of that list. Being in an enclosed, humid, sweaty gym where everyone is touching everything is not the most attractive service offering for the new normal, especially when your target consumer is a 'casual exerciser' to begin with.

Individuals have found ways to stay healthy and active that don't involve a gym membership, whether it be walking/jogging outdoors, home workouts, or other activities. Whatever it is, it's evident from Planet Fitness's latest quarterly report that these casual exercisers aren't rushing to sign up.

Planet Fitness has been experiencing significant topline depreciation over the past 5 quarters, which was to be expected from any health club amid the economic lockdowns. Still, the company doesn't seem to be making the material strides back to robust profitability despite its shares hitting fresh all-time highs at the end of February.

Its balance sheet has been experiencing a slightly concerning trend of growing liabilities and a negative shareholders deficit which continues to swell. Planet Fitness has over $580 in debt due by the end of next year, which it will likely have to roll over due to its lack of free cash flows. The company has $504 million in cash & equivalents. However, this is still insufficient to cover its debt maturities for the next year and a half, especially if cash-flows don't regain their pre-pandemic growth trend soon.

PLNT is experiencing some recent downward momentum, dipping below its 200-day moving average last, which appears to be a new resistance level for the stock, a bearish indicator.

PLNT shares have been pushed way too far amid this recovery rotation as reopening euphoria has investors and traders buying up every perceived beneficiary as the markets bet on the world going back to normal. As a result, the stock is currently trading at a forward P/E of more than 55x and a double-digit forward price to sales, far above its pre-pandemic levels. These seem like almost indisputably stretched valuation multiples for a business the persistently fails to meet analyst expectations. PLNT has further to fall before they reach an equitable level.

The electric vehicle (EV) boom is widely expected to continue in 2021 and beyond, especially after President Biden committed to spend a staggering $174 billion to lift the EV market. Several state governments have also provided subsidies for EVs. This is because EVs are environment-friendly, responsible for lesser noise and have a low maintenance cost.

Several countries this year have pledged to reduce carbon emissions. Companies like Amazon and salesforce.com are also aiming to be carbon-neutral soon. Needless to say, companies can easily lower emissions by electrifying their fleet. FedEx, in particular, mentioned that electrifying its fleet will largely help the company reach carbon neutrality by 2040.

Thus, with several companies aiming to reach carbon neutrality in the near term, the demand for EVs is soaring at the moment. In fact, notable traditional carmakers have now joined the EV bandwagon. For instance, players like General Motors, Ford Motor and Volkswagen have now started to venture into the EV market.

Fords F-150 EV is the latest to have an impact on the auto industry. Similarly, General Motors and Volkswagen are set to launch new battery-electric vehicles in the near future. By the way, EV battery sales increased handsomely in the first four months of the year, buoying companies like Tesla and Nikola. Apart from this, wireless charging mechanisms coupled with turbo-charges for EVs are having an overall positive impact on the EV market.

In fact, the EV market is now well-poised to expand, and as per Facts and Factors, citing a globenewswire article, the global EV market is projected to touch $700 billion by 2026, at a CAGR of 22% from 2021 to 2026. Additionally, another globenewswire article stated that Market Research Future expects the global EV market to see a CAGR of 21.6% from 2021 to touch $893.5 billion by 2027.

Whats more, the Boston Consulting Group already projected that EVs will more or less account for a third of the global auto industry by 2025, and more than 50% by 2030, easily surpassing sales of internal combustion engine (ICE) companies.

From rising concerns about CO2 emission, encouraging government policies to considerable investments by EV manufacturers, the global EV market is well-positioned to expand in the near future. An increase in initiatives to provide charging facilities in many areas and active involvement by original equipment manufacturers (OEM) in the EV space should contribute toward its growth trends. We have, thus, highlighted three solid EV stocks that are well-positioned to gain from this growing industry.

Tesla has played a pivotal role in transforming the EV market, the same way Amazon did to the retail landscape. By selling EV cars, Tesla is actually compelling the world to rely more on sustainable energy. In the United States, Tesla is one of the dominant players in the EV space and has made sure that EVs are now available for all and not just the affluent.

Tesla currently has a Zacks Rank #3 (Hold). The Zacks Consensus Estimate for its current-year earnings has moved up 0.5% over the past 60 days. The companys expected earnings growth rate for the current year is 92.9%. For the next five-year period, shares of Tesla are expected to gain 37.5%.

General Motors is now spending billions of dollars on EV vehicles to establish itself as a dominant player in the EV market. Citing a Barrons article, General Motors is aiming to spend $35 billion on EVs during the period 2021 to 2025. The article further noted that General Motors aims to sell 1 million EVs each year by 2025. In fact, General Motors aspires to be an all-EV seller by 2035.

General Motors currently has a Zacks Rank #1 (Strong Buy). The Zacks Consensus Estimate for its current-year earnings has moved up 7.5% over the past 60 days. The companys expected earnings growth rate for the current year is 11.6%. For the next five-year period, shares of General Motors are expected to gain 9.9%. You can see the complete list of todays Zacks #1 Rank stocks here.

Ford, in the meantime, has also raised its spending on EVs. Citing one of the abcnews articles, Ford declared that its Lincoln luxury brand would be electric by 2030.

Ford currently has a Zacks Rank #3. The Zacks Consensus Estimate for its current-year earnings has moved up 6.3% over the past 30 days. The companys expected earnings growth rate for the current year is 146.3%. For the next five-year period, shares of Ford are expected to gain 21.8%.

From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.

You know this company from its past glory days, but few would expect that its poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.

Free: See Our Top Stock and 4 Runners Up >>

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Teledyne, Planet Fitness, General Motors, Ford and Tesla highlighted as Zacks Bull and Bear of the Day - Yahoo Finance

Harry Kane dismisses fitness concerns, insists he is ‘fully focused’ on England – ESPN

Posted: at 1:53 am


England's struggling striker Harry Kane insists he has no fitness problems despite a difficult start to the Euro 2020 campaign in which manager Gareth Southgate has twice taken off his talisman when he has shown signs of flagging.

The England captain was replaced by Marcus Rashford in Friday's goalless Group D draw against Scotland at Wembley because Southgate wanted more energy in attack but Kane has assured fans he is not suffering from any injury.

"Gareth is within his rights to make the changes he thinks are best for the team," Kane, who managed only 19 touches in the Scotland game, according to The Guardian.

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"What we've learned over past tournaments is about trying to peak at the right time. The best time to be peaking is in the knockout stages and hopefully kick on from there."

England have had a muted start to the Euros after scraping a 1-0 win in their opener over Croatia, who beat England in the 2018 World Cup semifinals in Russia, and failing to break down a dogged Scotland side in front of the home fans at Wembley.

"Maybe in Russia there were times, towards the quarter- and semifinal, when I wasn't as sharp as I wanted to be," the 27-year-old Kane added. "In the end we didn't get to where we wanted to go, maybe partly for that reason.

"It's about managing the squad, making sure everyone is feeling as fit and sharp as possible. In my case, it was a tough couple of games [Croatia and Scotland] and it's about making sure I'm right for the rest of them.

"I didn't have any issues. I didn't feel physically I wasn't up to it. I felt going into those games as good as I've felt all season, if I'm honest."

Asked if a desire to leave his club Tottenham Hotspur had affected his performances for the national team, he replied: "Absolutely not. All my focus is on how I can help this team and how we can be successful in this tournament.

"I understand from a media point of view there is speculation but I am fully focused on the job here."

England, who have four points from two games, must beat group leaders the Czech Republic at Wembley on Tuesday to qualify for the last 16 in top spot. Kane believes that while they have been solid at the back they can improve up front.

"We all pride ourselves on not conceding, from front to back, and now I feel we can get better in the attacking third and be a bit more fluid and a bit more free and create a few more chances. Then we can be a strong team," he said.

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Harry Kane dismisses fitness concerns, insists he is 'fully focused' on England - ESPN

How Sean Garner is Making a Remarkable Impact in the Fitness Community – The Good Men Project

Posted: at 1:53 am


Health and fitness are of the utmost importance to live a great life. With the internet allowing us to have more connections to fitness professionals than ever, it has provided a plethora of opportunities to build a fitness business online. However, running a fitness business online can be challenging.

The industry is flooded with professionals, each offering the next best thing. However, if you are to become a successful online or in-person gym owner or trainer, you need to do it differently from what everyone else is. You must have a unique presence, in order to attract your dream clientele and to keep them as loyal, raving fans. Scaling up is no easy feat, unless you have the right guidance from an experienced professional.

Sean Garner, the force behind EntreFit.com, is committed to helping fitness trainers and gym owners grow their businesses. Sean knows exactly what needs to be done in a fitness training business, having been in the industry for more than 11 years. He understands how hard it can be to stand out from the crowd and as an experienced fitness business coach, youll see your business mark the online presence you know it deserves.

In Seans 11 years of experience, he has owned and successfully run multiple fitness businesses, including 2 CrossFit gyms, an outdoor boot camp, and a sports performance/functional training center. He also has vast experience in fitness training, having worked as an S&C coach for the Winnipeg Jets EHCL team.

Practicing what he preaches, Sean has furthered his expertise while writing and being a fitness advisor for Mens Health Magazine and is also the creator of the 6 Weeks Sweat Off Mens Health DVD and app products. Sean is the head creator of The Playbook App and Project DadBod, an online fitness coaching program.

At EntreFit, Sean and his team will introduce you to proven digital marketing systems which will help you grow your training business. He will also teach you the tricks of the trade, which will help you stop drowning in the unproductive pools of influencers. Sean will teach you how to bring consistent systems to your fitness training strategy, and with his guidance, you will stop struggling to convince clients of your value as a fitness trainer. Whats more? Sean will show you how to manage your time, so you achieve more in less time.

While helping you grow your online brand, Sean will cover topics such as creating and marketing your online fitness business, and exposing you to the systems you need to grow and scale it. He will also cover sales, creating an offer or a product, setting goals, and how to adopt an entrepreneur mindset. By the end of the interaction, you will also have learned how to find your dream clients and the best practices for your online fitness business.

Seans impact in the fitness community has been life-changing for many. If you are a gym owner or personal trainer who has been in the industry for two or more years and are looking to take your business online, Sean Garner is the online fitness business coach you need to contact.

Photo provided by the author.

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How Sean Garner is Making a Remarkable Impact in the Fitness Community - The Good Men Project

Life Time to open another fitness center in N.J. – nj.com

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Life Time, a health club chain, is opening another fitness center in New Jersey.

The club will be in Hackensack and open sometime this fall, according to a company spokeswoman. It will be at 390 Hackensack Ave. in the lower level of The Shops at Riverside.

An exact opening date has yet to be announced.

Unlike some other Life Time Fitness Clubs, the Hackensack center will occupy a smaller space with 16,000 square feet. The studio-only space will be used for group fitness, barre, cycle, yoga and Pilates. There also will be some cardio equipment.

There are currently six Life Time Fitness Clubs in New Jersey: Berkeley Heights, Bridgewater, Florham Park, Montvale, Mt. Laurel and Princeton.

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Intercom – WOMEN! Learn your fitness level and more. We need LOW-ACTIVE females for our study. – Ithaca College

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We are recruiting healthy, low-active females for a study of exercise capacity at Ithaca College. Participants will serve as controls for a grant funded study of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS). You will get a report of your exercise test results which will include information about your aerobic fitness level, other health measures, and baseline data for starting an exercise program if you are interested in doing so.

Who is eligible?

Healthy,low-activefemales between 25 70 years

Who isNOTeligible?- Smoker, or stopped smoking less than 1 year ago- Pregnant or breast feeding- Diabetic- Have a metabolic, cardiovascular and/or neuro-immune disease- Have an orthopedic limitation that prohibits stationary cycle exercise

What must you do?- Have a short phone conversation to determine eligibility.- If eligible, first meet remotely with our physician for clearance to participate in the study, then meet with the physician on-campus for a brief physical exam. During the on-campus meeting, urine and a small blood sample will be collected. You willnotbe charged any fee to be examined by our physician or for the blood and urine tests.- Complete questionnaires about your health/medical history and physical activity level- Complete 2 exercise tests on a stationary cycle separated by 24 hours. Each test requires 8-12 minutes of exercise. Blood will be collected before and after each exercise test.- You must stop taking all vitamins and mineral supplements for 2 weeks before the first exercise test, but can resume taking them after the 2nd exercise test.

The total time commitment for participation in this research study is about5hours.You will receive$300 for your time and contribution.

How can you sign up?For more information or to sign up for this study, contact: Betsy Keller at 607-274-7948 or email:MECFSstudy@ithaca.edu

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Intercom - WOMEN! Learn your fitness level and more. We need LOW-ACTIVE females for our study. - Ithaca College

California Roars Back: Governor Newsom Launches New Advisory Council on Physical Fitness and Mental Well-Being with Co-Chairs First Partner Jennifer…

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Governor announces new advisory council while visiting Central Valley health club now open at full capacity

BAKERSFIELD With Californias economy fully reopened and most COVID-19 restrictions lifted at gyms and fitness centers, Governor Gavin Newsom today announced the Governors Advisory Council on Physical Fitness and Mental Well-Being, a new advisory council tasked with exploring healthy strategies to ensure Californians can thrive. Placing a special emphasis on child physical and mental health, the Advisory Council will be led and convened by First Partner Jennifer Siebel Newsom, whoseCalifornia for ALL Kidsinitiatives support childrens physical, mental and social-emotional well-being, and Pro Football Hall of Fame inductee Ronnie Lott.

As California reopens, we must address the impacts this pandemic has had on physical fitness and mental health, said Governor Newsom. Today, with Californias First Partner and football legend Ronnie Lott, we are launching an Advisory Council that will focus on fitness and well-being, two issues that need a long-term commitment and strategy to ensure our residents, especially our youth, get the physical exercise and self-care they need to thrive.

The Governor was joined at an In-Shape Health Clubs location in Bakersfield today by Californias First Partner, who was a Division 1 athlete as an undergraduate student at Stanford University, as well as a member of the womens junior national soccer team.

Through the Governors Advisory Council, we will help ensure that Californians of all ages but especially children and youth are healthy in mind and body, and able to flourish in all aspects of their lives, said the First Partner. After all, a healthy California starts with healthy kids and families.

As a professional athlete, I always gave my best on and off the field, said Ronnie Lott, who helped secure four Super Bowl victories for the San Francisco 49ers. By incorporating fitness and mental well-being into the lives of our youth, we will be giving them some of the skills and support that helped me during my career as a professional athlete.

The Advisory Council will include representatives from health and wellness organizations, youth sports programs, education, the entertainment and fitness industry, and others from around the state. Included among the Councils activities are:

On behalf of the California Fitness Alliance, we are thrilled to collaborate with Governor Newsom and the new fitness council to make California the healthiest state in the nation. Together, we will continue our mission to provide equitable access to fitness for all Californians while educating them on the mental and physical benefits of exercise and motivating them to get moving, said Francesca Schuler, Co-Founder of the California Fitness Alliance and CEO of In-Shape Health Clubs.

According to the Centers for Disease Control and Prevention,lifetime attitudesrelated to physical activity, sports, nutrition and wellness are formed early on in life, and establishing healthy dietary and physical habits during childhood is critical to preventing chronic diseases in adulthood. Activities that promote physical healthsupportchildrens mental health, their social and emotional learning, as well as their academic and life success. Specifically, engaging in regular physical activityreduces the riskof developing depression in children and adults and can improve many of the symptoms experienced by people with depression.

The Advisory Council will be comprised of up to 15 members, who will be named at a later date.

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California Roars Back: Governor Newsom Launches New Advisory Council on Physical Fitness and Mental Well-Being with Co-Chairs First Partner Jennifer...

Build your perfect home gym with AmazonBasics fitness gear and games up to 35% off – 9to5Toys

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Today only, as part of itsPrime Day Deals, Amazon is offering its selection of AmazonBasics fitness essentials starting at $8.50. Our favorite today is its Tabletop Foosball with Accessories for $24.70 Prime shipped. Usually selling for around $37.50, todays savings mark the lowest price weve ever tracked at a solid 35% off. Ready to add indoor play to any table or rec room, this tabletop foosball game is crafted from MDM engineered wood and sturdy steel rods for fast-placed play. The design is classic, with an arena of painted foosball players and two genuine foosballs for you to enjoy. Reviews are still a bit thin on this one, but you can peruse the entire selection of highly-rated AmazonBasics deals below.

While were stocking up on essentials for the home gym, you can also score a ton of AmazonBasics kitchenware starting at just $5. Everything you need to stockpile your kitchen, or get your grads ready for college living, is up to 57% off. And thats just the start of todays Prime Day savings, so be sure to check in with our deal hub as we update around the clock here at 9to5Toys.

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Build your perfect home gym with AmazonBasics fitness gear and games up to 35% off - 9to5Toys

Health fitness and dance classes on Zoom – The Sagamore

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As cameras turn on for class, students stretch their muscles in their rooms and wait for instructions from their dance teacher on their screens.

Dance and fitness classes over zoom are a unique part of remote learning and due to the level of motion and activity that is associated with these classes, teachers and students are adapting. All parties involved must make the best out of what they have.

With all classes online, everyone has had to adjust to being in a different environment. Sophomore and advanced dance student Alissa Rogozin had to adjust her view of class quite literally.

Space was an issue because I would bump into things, and I would have to adjust the camera in order to see my whole body, Rogozin said.

A secondary stress that some students face is doing physical activity in front of a camera. Some may find working out on camera to be nerve-wracking, but Angela Lee, a senior taking a health and fitness class, has not found this to be a problem.

It is awkward because you are in a Zoom and you are doing physical activity, but its definitely not as bad as I thought it was going to be. We are supposed to turn off our cameras, so you can only see yourself and the teacher, Lee said.

Doing physical activity though the screen may be challenging for students but, for the teachers, making sure that the curriculum benefits the students is a priority. Yoga instructor and Spanish teacher Elizabeth Gorman has different ways to teach yoga online, and she has also fit in lessons about mindfulness to benefit her students.

We are still experimenting and trying to find the best way, but I dont pretend that I know the best way to do it. The curriculum is really a health and wellness curriculum that supports the students in being active every day and learning about different topics like fitness and mindfulness, Gorman said.

The way Gorman instructs her yoga class has changed in order to adjust to being remote. She has to prepare more for her class ahead of time in order to have class ready on Zoom.

I demonstrate in my living room or if Im filming a yoga sequence ahead of time, I have one screen projecting a video or demonstrating and on my other monitor I have my students and the zoom, Gorman said. I have them set their cameras up and keep them on so I can watch them practicing. If I am playing a video, then I am more available to support and watch them.

Dance over Zoom requires students to create a big enough space to dance. In Myra Hernandezs advanced dance class, students stretch and then dance together.

I think Ms. Hernandez is doing a good job of keeping normality in the classroom. We do stretches together in order to warm up our arms and legs and then we stretch on our own if we need to, Rogozin said. Then we go into a combination where she has prepared a choreographed dance that she teaches and we just go through the dance and sometimes we do it in groups. Sometimes she will tell half of the class to turn off their cameras and have them watch the other half dance.

Even with classes going well online and during hybrid students and teachers hope to return full time when it is safe to.

I would love to be back full time because that would also mean that we are in a place where we have a vaccine or that we have it under such control that it is safe but I just dont know if that is realistic, Gorman said.

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Health fitness and dance classes on Zoom - The Sagamore

The Dad Bod Is Back: Planet Fitness Spotlights The Ultimate Symbol Of Confidence And Body Positivity With Fifth Annual Survey Results – PRNewswire

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HAMPTON, N.H., June 16, 2021 /PRNewswire/ --Planet Fitness, one of the largest and fastest-growing global franchisors and operators of fitness centers with more members than any other fitness brand, is once again shining a spotlight on an iconic body type the "dad bod." As home of the Judgement Free Zone, Planet Fitness encourages everyone to embrace themselves as they are, and for a fifth year in a row and just ahead of Father's Day new insights from a national study* highlight how American men and women feel about the body type that's defined the art of fatherhood for five straight years.

In 2017, the inaugural "dad bod" study uncovered that nearly seven in 10 women (69 percent) find dad bods attractive, and 64 percent of men with dad bods were comfortable and confident in their own skin. Today, those same figures continue to climb, with 69 percent of men with dad bods noting they are confident and comfortable with their physique, and 70 percent of women (and 52 percent of men) proclaiming they are (still) attracted to men with the body type.

But, despite a growing affinity for and universal acceptance of the body type among women (72 percent), half of all men with dad bods (50 percent) feel judged by others for their bodies a number that's jumped 10 percent since just last year alone.

When it comes to fatherhood, however, one of the unanticipated impacts of this past year is how the role of "dad" has changed for the better. The 2021 study found that the pandemic undoubtedly brought fathers closer to their families. Nearly nine in 10 (88 percent) dads feel that they have become better parents to their children because of the pandemic, and a majority of fathers agree that their relationships with their kids (84 percent) and partner (74 percent) have only gotten stronger, as well. In the end, four in five dads (80 percent) are simply grateful for the extra time spent with their kids and families.

Additional insights surrounding men with dad bods whether they're lifting weights at the gym or lifting toddlers out of car seats include:

"Fitness is all about being happy and healthy in your own skin, not worrying about what others might think, and our fifth annual 'dad bod' survey results prove just that," said Jamie Medeiros, Vice President of Marketing at Planet Fitness. "This Father's Day and beyond, we want to remind everyone that whether you're heading to the gym for the first time or heading to the carpool pick-up lane for the hundredth, all are accepted and welcome at Planet Fitness."

Planet Fitness encourages everyone to stay active and healthy at a pace that's right for them, and its top priority is keeping its members and employees safe. The company continues to implement numerous enhanced COVID-19 safety and sanitization protocols at its well-ventilated and spacious clubs, such as:

For more information on Planet Fitness and to find a club near you, visit http://www.PlanetFitness.com.

*Online survey conducted by Kelton Global to 1,005 nationally representative Americans ages 18 and over, with a margin of error of +/- 3.1 percent.

About Planet FitnessFounded in 1992 in Dover, NH, Planet Fitness is one of the largest and fastest-growing franchisors and operators of fitness centers in the United States by number of members and locations. As of March 31, 2021, Planet Fitness had more than 14.1 million members and 2,146 stores in 50 states, the District of Columbia, Puerto Rico, Canada, Panama, Mexico and Australia. The Company's mission is to enhance people's lives by providing a high-quality fitness experience in a welcoming, non-intimidating environment, which we call the Judgement Free Zone. More than 95% of Planet Fitness stores are owned and operated by independent business men and women.

SOURCE Planet Fitness, Inc.

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The Dad Bod Is Back: Planet Fitness Spotlights The Ultimate Symbol Of Confidence And Body Positivity With Fifth Annual Survey Results - PRNewswire

Local woman hoping to be named Ms. Health and Fitness. Here’s how you can help. – East Idaho News

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Jo Lawrence is a personal trainer at the YMCA in Idaho Falls and she just entered a national contest in hopes of being featured on the cover of a fitness magazine. | Rett Nelson, EastIdahoNews.com

IDAHO FALLS A local woman is hoping to win a national contest and shes asking for your support.

Jo Lawrence has been a personal trainer at the YMCA in Idaho Falls for many years and works as a trainer and nutrition coach at Melaleuca. Shes worked with clients nationwide and recently got wind of a womens fitness competition sponsored by Muscle and Fitness Her magazine.

You have to get as many votes as you can to get recognized as the next Ms. Health and Fitness, Lawrence tells EastIdahoNews.com.

The candidate with the most votes at the end of the competition wins $20,000 and will be featured on the cover of an upcoming issue of the magazine.

The contest was open to anyone who is fit and living a healthy lifestyle. Lawrence is one of dozens of candidates who applied. She says it was a friend of hers who first heard about it and suggested she apply.

Im not a social media girl at all. Ive been trying to do it a little more, but (as I looked into it), I thought, What the heck! Why not!, says Lawrence. I try to stay fit and strong and healthy for my clients, my family and my kids as an example.

Physical fitness has been important to Lawrence since she was a child. One of the things that drew her to that lifestyle was the example of those around her.

My stepmom was a big woman. I loved to workout and run but I also loved to eat. She would say, If you keep doing that, youre going to look like me one day. I saw how unhealthy she was and I did not want that to be me. I swore then that I would not be like that, Lawrence explains.

Lawrence says she was a cardio junkie throughout her early adult years for the purpose of staying lean and fit. She never really had a specific goal in mind until she turned 39.

Thats when her expectations became a lot bigger.

When I turned 39, my goal before I hit 40 was to do a competition. I wanted to reshape my whole body. Ive been addicted since then, she says.

Lawrence is now 51 and after this competition, her next goal is to start training to climb to the base camp of Mt. Everest.

RELATED | Big donation helps cancer survivors recover physically and mentally

Lawrence has worked with hundreds of clients over the years and she says its rewarding to help others with their fitness goals.

I train both men and women, but my female clients I especially enjoy training because a lot of them dont realize what weights can do for you. They think weights are going to bulk you up like Arnold, but I try to get it in their head that (using weights) will help them lean out, gain muscle and look healthier, she says.

Another common issue she deals with among women is the mentality that eating carbs will make you fat.

Eat all the carbs, please, honey, says Lawrence. Thats what helps you to get muscle.

In a world that is saturated with messages about body image, Lawrence says its an ongoing challenge to help clients overcome negative stereotypes and change their mindset so they can achieve their goals.

For those looking for some motivation to be healthy and fit in their daily life, Lawrence offers some basic tips.

Put a pair of tennis shoes in the way of your vision when you walk in the door. You walk in the door, you see the kitchen and youre hungry so you go right to eating. Put a pair of shoes or a dumbbell in your vision so you see and have that trigger to go workout or walk. Just do something, she says.

When it comes to eating, Lawrence says dont think in terms of dieting. Instead, just tweak what youre already eating to make it a little more nutritious. Moderation is the key, she says.

Lawrence is asking for your vote to help her win this competition. Voting is open until June 24 at 8 p.m. There is no limit on how many times you can vote, she says, but youre only allowed one vote a day.

To cast your vote or learn more, click here.

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Local woman hoping to be named Ms. Health and Fitness. Here's how you can help. - East Idaho News

Oyster Point Pharma Announces Enrollment of First Subject in the OLYMPIA Phase 2 Clinical Trial of OC-01 (varenicline) Nasal Spray for Patients with…

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PRINCETON, N.J., June 21, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases, today announced enrollment of the first subject in the OLYMPIA Phase 2 clinical trial of OC-01 (varenicline) nasal spray for the treatment of Stage 1 Neurotrophic Keratopathy (NK).

This is an exciting milestone as we continue to develop this potentially new treatment option for patients with Stage 1 Neurotrophic Keratopathy, said Jeffrey Nau, Ph.D., MMS, president and chief executive officer of Oyster Point Pharma. We believe that NK affects more patients than are currently diagnosed as the disease has the potential to be undiagnosed or misdiagnosed. Stage 1 NK patients may present with additional ocular surface issues, including dry eye disease, which affects 38 million1 patients.

The OLYMPIA Phase 2 study is a multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with Mackies Classification Stage 1 Neurotrophic Keratopathy. The study is expected to enroll approximately 100 subjects at approximately 18 U.S. sites. In this clinical trial, OC-01 (varenicline) nasal spray will be administered three times a day, as compared to placebo (vehicle) nasal spray. The pre-specified primary endpoint of the trial will be the percentage of subjects who achieve complete resolution of fluorescein corneal staining at Day 56.

NK is characterized as a degenerative disease of the cornea due to impairment of trigeminal innervation that results in corneal epithelial damage, said Marian Macsai, M.D., chief medical officer of Oyster Point Pharma. We believe that OC-01 nasal spray may activate natural tear production through the trigeminal parasympathetic pathway, bypassing the impaired corneal nerves to stimulate the production of natural tear film and potentially improve corneal sensitivity and healing.

About Oyster Point PharmaOyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases.

About OC-01 (varenicline) Nasal SprayOC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. The parasympathetic nervous system, the rest and digest system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to activate natural tear film production. The human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film is responsible for forming the primary refracting surface of the eye, as well as protecting and moisturizing the cornea. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in this indication in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established.

About Neurotrophic KeratopathyNeurotrophic Keratopathy (NK) is a rare disease characterized by decreased corneal sensitivity and poor corneal healing. The most common causes of corneal sensation loss are viral infection (herpes simplex virus and herpes zoster keratoconjunctivitis), followed by chemical burns, physical injuries, and ocular surface surgery. In addition, systemic diseases such as diabetes and multiple sclerosis may decrease sensory nerve function or damage sensory fibers. NK can be classified broadly into three stages: Stage 1 (mild) consists of ocular surface irregularities and reduced vision, Stage 2 (moderate) exhibits a non-healing persistent defect of the corneal epithelium, and Stage 3 (severe) exhibits corneal ulceration, which may progress to corneal melting and perforation. If not adequately addressed, NK can lead to vision loss and a breakdown of corneal integrity, potentially leading to cornea transplantation.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations and assumptions of the Company regarding the future of the Companys business, our future plans and strategies, regulatory approvals, clinical results, future financial condition and other future conditions. All statements other than statements of historical facts contained in this press release, including express or implied statements regarding product candidates, regulatory approvals, planned pre-clinical studies and clinical trials, expected results of pre-clinical studies or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, are forward-looking statements. The words if approved, may, will, should, would, expect, plan, anticipate, could, intend, target, project, contemplate, believe, estimate, predict, potential or continue or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the uncertainties inherent in pharmaceutical research and development, including pre-clinical study and clinical trial results and additional analysis of existing data, and the likelihood of our pre-clinical studies and clinical trials demonstrating the safety and efficacy of our product candidates, and other positive results; the timing of initiation of our future clinical trials, and the reporting of data from our current and future trials; the timing or likelihood of regulatory filings and approvals for our product candidates; our ability to obtain and maintain regulatory approvals of our product candidates; our plans relating to commercializing our product candidates, if approved; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our plans relating to the further pre-clinical and clinical development and manufacturing of our product candidates, including additional indications which we may pursue; the prevalence of dry eye disease and neurotrophic keratopathy and the size of the market opportunity for our product candidates; the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for pre-clinical studies and clinical trials; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; market conditions; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; and other risks described in the Risk Factors section included in our public filings that we have made and will make with the Securities and Exchange Commission. The Company is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

1- Market Scope 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025

Investor Contact:Tim McCarthyLifeSci Advisors, LLC(212) 915-2564investors@oysterpointrx.com

Media Contact:Sheryl Seapy, Real Chemistry(213) 262-9390sseapy@realchemistry.com

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Oyster Point Pharma Announces Enrollment of First Subject in the OLYMPIA Phase 2 Clinical Trial of OC-01 (varenicline) Nasal Spray for Patients with...

Spruce Biosciences Announces Publication of Phase 2 Results for Tildacerfont in Journal of Clinical Endocrinology and Metabolism – Business Wire

Posted: at 1:52 am


SAN FRANCISCO--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced the publication of the results from two Phase 2 clinical studies investigating tildacerfont in adult patients with classic CAH in the Journal of Clinical Endocrinology and Metabolism.

The data published in the Journal of Clinical Endocrinology and Metabolism demonstrates the potential of tildacerfont to reduce androgen excess without increasing the total daily glucocorticoid dose in patients with classic CAH, said Kyriakie Sarafoglou, MD, Associate Professor, Department of Pediatrics Divisions of Endocrinology and Genetics & Metabolism at the University of Minnesota Medical School.

SPR001-201 was an open-label, multi-dose, Phase 2a dose-escalation study which evaluated the ability of tildacerfont to lower adrenocorticotropic hormone (ACTH), 17-hydroxyprogesterone (17-OHP), and androstenedione (A4) at doses ranging from 200mg daily to 1,000mg daily in patients with congenital adrenal hyperplasia due to 21-hydroxylase deficiency. SPR001-202 was an open-label, 12-week Phase 2a clinical trial, which assessed the ability of a daily dose of 400mg of tildacerfont to lower ACTH, 17-OHP, and A4 over a 12-week dosing period. SPR001-201 and SPR001-202 comprised the entire Phase 2a clinical development program for tildacerfont in adult classic CAH. In the studies, efficacy was evaluated by changes from baseline in ACTH, 17-OHP, and A4 according to baseline A4 2x upper limit of normal (ULN), denoted as baseline good disease control, or A4 >2x ULN, denoted as baseline poor disease control. Safety was evaluated using adverse events and laboratory assessments.

The results of the studies showed that tildacerfont reduced key hormone biomarkers towards normal levels in the baseline poor disease control group, including normalization of ACTH and A4 in 60% and 40% of patients, respectively. In patients with baseline good disease control, these hormones were maintained near or below normal levels. Tildacerfont was generally safe and well-tolerated. The findings from these studies support the ongoing global late-stage studies of tildacerfont in adults with classic CAH CAHmelia-203 (assessing the ability of tildacerfont to reduce excessive adrenal androgens in patients with poor disease control) and CAHmelia-204 (assessing the ability of tildacerfont to reduce glucocorticoid usage in patients with good disease control while maintaining control of androgens).

Classic CAH is a serious and potentially life-threatening condition that has not benefited from new effective treatment options in approximately 50 years, said Rosh Dias, M.D., MRCP, Chief Medical Officer of Spruce Biosciences. People living with classic CAH must grapple with the difficult balance of managing their adrenal androgen excess and supraphysiologic dosing of glucocorticoids, the existing standard of care therapy. In our Phase 2a studies, I was pleased to see that tildacerfont was able to produce meaningful reductions in highly elevated hormones in classic CAH patients, including in some cases normalization of these hormones, over a 12-week period without increases to daily steroid doses. This has not been reported to date with any other investigational product candidate.

About Tildacerfont

Tildacerfont is a potent and highly selective, non-steroidal, oral antagonist of the CRF1 receptor, which is the receptor for corticotropin-releasing factor (CRF), a hormone that is secreted by the hypothalamus. The CRF1 receptor is abundantly expressed in the pituitary gland where it is the primary regulator of the HPA axis. By blocking the CRF1 receptor, tildacerfont has the potential to address the uncontrolled cortisol feedback regulatory pathway in CAH, and in turn reduce the production of ACTH in the pituitary, limiting the amount of androgen produced downstream from the adrenal gland. Tildacerfont has been evaluated in 171 patients across seven clinical trials in which it has been generally well tolerated. No drug-related serious adverse events have been reported related to tildacerfont treatment.

About Spruce Biosciences

Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need. Spruce is initially developing its wholly owned product candidate, tildacerfont, as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years. Spruce is also developing tildacerfont for women suffering from a rare form of polycystic ovary syndrome (PCOS) with primary adrenal androgen excess. To learn more, visit http://www.sprucebiosciences.com and follow us on Twitter @Spruce_Bio, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Spruces clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as potential, demonstrates, may and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruces current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruces business in general, the impact of the COVID-19 pandemic, and the other risks described in Spruces filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on managements assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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Spruce Biosciences Announces Publication of Phase 2 Results for Tildacerfont in Journal of Clinical Endocrinology and Metabolism - Business Wire

GSK and Vir Biotechnology Announce Continuing Progress of the COMET Clinical Development Program for Sotrovimab – BioSpace

Posted: at 1:52 am


LONDON and SAN FRANCISCO, June 21, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced final, confirmatory results from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial Intent to Care Early) trial demonstrating that sotrovimab, an investigational SARS-CoV-2 monoclonal antibody, significantly reduced the risk of hospitalization or death among high-risk adult outpatients with mild-to-moderate COVID-19. Additionally, the U.S. National Institutes of Health (NIH) updated its COVID-19 treatment guidelines to recommend sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.

The primary efficacy analysis of all 1,057 patients in the COMET-ICE trial demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalization for more than 24 hours or death due to any cause, by Day 29 compared to placebo, meeting the primary endpoint of the trial.

The number of patients in the trial who were hospitalized for >24 hours for acute management of any illness or death from any cause at Day 29 was six patients in the sotrovimab arm (1%), versus 30 patients in the placebo arm (6%). In the sotrovimab arm, it is possible that half of those patients who were hospitalized were for reasons other than progression of COVID-19 (e.g., small bowel obstruction, lung cancer and diabetic foot ulcer); this was not the case for patients in the placebo arm. In the safety analysis, 1,037 participants were followed through at least 29 days. The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo. The companies plan to submit the full COMET-ICE data set to a peer-reviewed journal for publication.

Christopher Corsico, senior vice president of development, GSK, said: Effective medicines to treat those who become infected with SARS-CoV-2 remain a critical part of the solution to this pandemic. We are working diligently to increase access to sotrovimab in the U.S. and across the globe, including evaluating the potential to simplify administration with an intramuscular formulation.

George Scangos, Ph.D., chief executive officer of Vir, said: We are pleased that the profound interim efficacy from the COMET-ICE trial has now been validated by the full study population. These results, combined with the growing number of pending global authorizations, as well as the recent recommendation by the NIH COVID-19 Treatment Guidelines Panel, support our confidence in the potential role of sotrovimab in the fight against this pandemic.

Updated NIH Guidelines Recommend SotrovimabThe NIH recently updated its guidelines regarding the emergency use authorizations of anti-SARS-CoV-2 monoclonal antibodies for the treatment of COVID-19 in the U.S. to recommend the use of sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression. The guidelines note that the target binding site of sotrovimab is in a region of the virus that does not overlap with the binding site location of key mutations in current variants of concern and interest. These guidelines were based upon an interim analysis of 583 patients in the COMET-ICE trial, which was stopped early in March 2020 by an independent data monitoring committee because interim results demonstrated evidence of sotrovimabs clinical efficacy. The interim study results demonstrated an 85% (p=0.002) reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.

These data have informed global regulatory reviews to date, including the positive scientific opinion issued by the European Medicines Agencys (EMA) Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004, as well as the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA).

The companies are actively working with government agencies around the world to make sotrovimab available to patients in need of treatment.

Continued Progress with the COMET Clinical Development ProgramThe companies are also pleased to announce continued progress with the robust COMET clinical development program, which aims to provide clinical evidence from several studies over the course of the next year.

GSK and Vir are committed to ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. Data from in vitro studies, published in bioRxiv, have demonstrated that sotrovimab maintains activity against circulating variants of concern and interest, including the Gamma (P.1), Epsilon (B.1.427/B.1.429), Delta (B.1.617.1), Iota (B.1.526), Beta (B.1.351) and Alpha (B.1.1.7) variants. GSK and Vir are continuing to evaluate the ability of sotrovimab to maintain activity against new and emerging variants through in vitro studies. The clinical impact of this in vitro variants data is not yet known.

About Sotrovimab (previously VIR-7831)Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencors Xtend technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

The following is a summary of information for sotrovimab. Healthcare providers in the U.S. should review the Fact Sheets for information on the authorized use of sotrovimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers. For more information on the EMA positive scientific opinion, please review the EU Conditions of Use.

Important Information about SotrovimabSotrovimab has been authorized by the FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.

Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Authorized Use The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Authorized Use Sotrovimab is not authorized for use in patients:

Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Important Safety Information for Sotrovimab

Warnings

There are limited clinical data available for sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis have been observed with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening.

Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness and diaphoresis.

Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.

Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration

Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.

Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19

Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Therefore, sotrovimab is not authorized for use in patients: who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

ADVERSE EVENTS

The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (2%) and diarrhea (1%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

Lactation

There are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. Individuals with COVID-19 who are breastfeeding should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

About the Vir and GSK CollaborationIn April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Virs proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSKs expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

GSK Commitment to Tackling COVID-19GSKs response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development with partner organizations.

GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, we recently announced positive Phase 2 data from our collaboration with Sanofi to develop an adjuvanted, protein-based vaccine candidate and expect to begin a Phase 3 trial in Q2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVacs first generation COVID-19 vaccine. GSK is also providing manufacturing support for up to 60m doses of Novavax COVID-19 vaccine in the UK.

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy, based on an interim analysis of data from the trial. An analysis of data through Day 29 of the COMET-ICE trial was consistent with interim results. We have received Emergency Use Authorization in the U.S. and are seeking authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

Virs Commitment to COVID-19Vir was founded with the mission of addressing the worlds most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.

About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com/about-us.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit http://www.vir.bio.

GSK Cautionary Statement Regarding Forward-Looking StatementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

Vir Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the final data from the COMET-ICE trial, NIH guidelines recommending the use of sotrovimab in the treatment of COVID-19, the initiation of Virs COMET-TAIL clinical trial, the clinical development program for sotrovimab, Virs capacity to manufacture and supply sotrovimab, the ability of sotrovimab to treat and/or prevent COVID-19, the ability of sotrovimab to maintain activity against circulating variants of concern, and statements related to regulatory authorizations and approvals, including plans and discussions with the FDA, EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Virs competitors, changes in expected or existing competition, delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Registered in England & Wales:No. 3888792

Registered Office:980 Great West RoadBrentford, MiddlesexTW8 9GS

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GSK and Vir Biotechnology Announce Continuing Progress of the COMET Clinical Development Program for Sotrovimab - BioSpace

CytomX Therapeutics Announces Publication of First-in-Human Data for CX-2029 in Clinical Cancer Research – GlobeNewswire

Posted: at 1:52 am


SOUTH SAN FRANCISCO, Calif., June 21, 2021 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, today announced that results from its Phase 1 first-in-human study of CX-2029 in patients with advanced solid tumors were published online in the peer-reviewed journal Clinical Cancer Research. This study showed that CX-2029, currently being co-developed by CytomX and AbbVie, was generally well-tolerated and can elicit anti-tumor responses in certain patients.

These results highlight that our industry-leading Probody platform can be successfully leveraged to create conditionally activated ADCs against previously undruggable targets. For the first time, CD71 has been shown to be a viable therapeutic cancer target, said Alison L. Hannah, M.D., senior vice president and chief medical officer of CytomX Therapeutics.

CD71 is a cell surface protein essential for iron uptake in dividing cells and is highly expressed in a number of solid and hematologic cancers. However, given its central role in iron metabolism, CD71 is present on most healthy cells and has been, until now, undruggable with conventional ADCs. CX-2029 is designed to be activated in the tumor microenvironment by tumor-associated proteases, thereby limiting off-tumor toxicity and creating a therapeutic window for CD71.

The goal of this Phase 1 dose-escalation, multicenter study was to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of CX-2029. A total of 45 patients were enrolled to receive CX-2029 intravenously every three weeks at dose levels ranging from 0.1 mg/kg to 5 mg/kg.

Encouraging preliminary clinical activity was observed at doses of 2 mg/kg and higher. Notably, three of four patients with squamous non-small cell lung carcinoma (NSCLC) had stable disease (SD) or better, including two confirmed partial responses (PRs) (at doses of 3 and 5 mg/kg); and seven of eight patients with head and neck squamous cell carcinoma (HNSCC) had SD or better, including one confirmed PR at 3 mg/kg and one prolonged SD ongoing at approximately 25 weeks, as of the reported August 2020 data cutoff.

Despite having received a median of three prior lines of cancer regimens (range, 116), these heavily-pretreated patients generally tolerated CX-2029 well. The most common dose-dependent adverse events were anemia and neutropenia, toxicities commonly associated with the payload of this ADC (monomethyl auristatin E). Based on several safety parameters, including no cycle 1 DLTs, no discontinuations due to toxicity, and a long-term tolerability that appeared to be acceptable for chronic administration with supportive care for anemia, 3 mg/kg every 3 weeks was declared the recommended Phase 2 dose.

The ongoing Phase 2 expansion study is evaluating CX-2029 as monotherapy in four cohorts: squamous NSCLC, HNSCC, esophageal and gastroesophageal junction cancers (both adenocarcinoma and squamous histologies), and diffuse large B-cell lymphoma. Initial results are expected in the fourth quarter of 2021.

AboutCytomX TherapeuticsCytomX is a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies. We are developing a novel class of investigational conditionally activated therapeutics, based on our Probody technology platform, for the treatment of cancer. CytomX has strategic drug discovery and development collaborations with AbbVie, Amgen, Astellas, and Bristol Myers Squibb.

Probody therapeutics are conditionally activated biologics designed to remain inactive until they are activated by proteases in the tumor microenvironment. As a result, Probody therapeutics are intended to bind selectively to tumors and decrease binding to healthy tissue, to minimize toxicity and potentially create safer, more effective therapies. As leaders in the field, our innovative technology is designed to turn previously undruggable targets into druggable targets and to enable more effective combination therapies. CytomX and its partners, comprised of leading biotechnology and pharmaceutical companies, have developed a robust pipeline of potential first-in-class therapeutic candidates against novel, difficult to drug targets and potential best-in-class immunotherapeutic candidates against clinically validated targets. The CytomX clinical-stage pipeline comprises five assets, four of which are in Phase 2 clinical studies. First-in-class product candidates against previously undruggable targets include a CD166-targeting conditionally activated antibody-drug conjugate wholly owned by CytomX (praluzatamab ravtansine, CX-2009) and a CD71-targeting conditionally activated antibody-drug conjugate partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer targets that are considered to be inaccessible to conventional antibody-drug conjugates due to their presence on many healthy tissues. The CytomX clinical-stage pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probodies, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and our wholly-owned conditionally activated anti-PD-L1 antibody, pacmilimab (CX-072). For additional information about CytomX Therapeutics, visit http://www.cytomx.com and follow us on LinkedIn and Twitter.

CytomX Therapeutics Forward-Looking StatementsThis press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomXs or any of its collaborative partners product candidates, including praluzatamab ravtansine (CX-2009), CX-2029, BMS-986249, BMS-986288, and pacmilimab (CX-072), the potential benefits or applications of CytomXs Probody platform technology, CytomXs ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288, and pacmilimab (CX-072), and the timing of the commencement of clinical trials and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomXs novel Probody platform technology; CytomXs clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of early clinical trials may not be predictive of future results, including clinical trials for CX-2029; the possibility that CytomXs clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomXs dependence on the success of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288, and pacmilimab (CX-072); CytomXs reliance on third parties for the manufacture of the companys product candidates; and possible regulatory developments inthe United Statesand foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomXs Quarterly Report on Form 10-Q filed with theSEConMay 6, 2021. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.

Probody is a U.S. registered trademark of CytomX Therapeutics, Inc.

CytomX Contact:Chau Cheng, PhD MBAVP, Investor Relations & Corp. Communicationsccheng@cytomx.comDirect: (650) 273-4999

Investor and Media Contact:Stern Investor RelationsStephanie Ascherstephanie.ascher@sternir.com212-362-1200

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CytomX Therapeutics Announces Publication of First-in-Human Data for CX-2029 in Clinical Cancer Research - GlobeNewswire

COVID-19: India Has a Habit of Bad Clinical Trials – The Wire Science

Posted: at 1:52 am


Representative: A health official draws a dose of Covishield in Colombo, Sri Lanka, January 29, 2021. Photo: Reuters/Dinuka Liyanawatte/File Photo

Mumbai: On June 15, All India Institute of Medical Sciences (AIIMS), Delhi, started inoculating children with Covaxin as part of Bharat Biotechs paediatric clinical trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin in 2- to 18-year-old children.

The trial plans to enrol around 525 children across hospitals. This is a very small cohort. For example, Modernas paediatric trial aims to recruit 7,050 children aged 6 months to 12 years. It had conducted another trial with 3,732 teenagers aged 12-18 years. Similarly, Pfizer is conducting a paediatric trial with 4,644 children aged 6 months to 12 years; and its trial with adolescents enrolled 2,260 participants aged 12-15 years.

Experts have raised concerns about Bharat Biotechs trial over its small size, and because it doesnt have a placebo arm.

And while the criticism is significant, it may not be limited to Bharat Biotech.

The Hyderabad-based pharmaceutical companys small paediatric trial is one of many clinical studies conducted in India that have, or intend to have, a small number of participants.

Such studies are said to be underpowered. According to one 2007 paper, a studys power is the probability of saying there is a difference when a difference actually exists. An underpowered study does not have a sufficiently large sample size to answer the research question of interest.

It is possible to calculate the ideal sample size before the trial begins. This means while trial investigators can write off an inconclusive result as the product of the small sample size, theyre expected to have good reasons for why they didnt include more participants.

However, Indias drug regulator, the Drug Controller General, has complicated this picture, especially in the last couple years. It has passively condoned underpowering by awarding the fruits of such trials with emergency use approvals. Itolizumab was okayed after a trial with 30 participants, favipiravir with 150 participants, Virafin with 290 participants (40 and 250 in phase 2 and 3 trials) and 2-deoxy-d-glucose with 330 participants (110 and 220 in phase 2 and 3 trials).

Also read: Is Biocons Itolizumab Good News? Hard to Tell, Thanks to the Bad Science.

* * *

Randomised control trials are difficult to conduct more so with a crumbling health infrastructure in the middle of an epidemic but this isnt an acceptable excuse to not have one.

Conducting multiple small trials with a few hundred participants is not the same as conducting one large trial with thousands. When the former are summed up, their underpoweredness is magnified, rendering the total findings less than useful.

In India, researchers who plan to conduct clinical studies involving human participants need to register each study on the Clinical Trial Registry of India (CTRI) before it begins. Since the pandemic began, more than 1,300 such trials have been registered on CTRI.

Not all trials are completed; many never kick off and many others stop midway, for multiple reasons. This said, Indias COVID-19 research output has still been piddling especially in quality, because most studies are underpowered and often methodologically flawed as well.

For example, there are at least 15 trials registered on CTRI involving hydroxychloroquine, the drug that India pushed in a big way in 2020. These trials together include thousands of patients but they produced little usable evidence last year.

Instead, all the evidence we have on the efficacy of different drugs has come from large adaptive trials, especially the WHOs SOLIDARITY, the UKs RECOVERY and the USs ACTT trials.

(Researchers sometimes unearth important patterns by studying multiple small trials together. However, this isnt possible when the trials measure different parameters, thus arriving at incomparable outcomes.

For example, trials for hydroxychloroquine at AIIMS Delhi, with 116 participants, and at AIIMS Raipur, with 50 measured progression to severe disease and virological clearance at day six, with no overlap.)

No country for negative trials

Another problem is publication bias when researchers dont publish their results because the latter are deemed to be insignificant.

For example, Mumbai-based Wockhardt conducted a trial for convalescent plasma in May 2020. In a meeting with experts at the Central Drug Standards Control Organisation on February 11, 2021, Wockhardt submitted that its trial failed to show any benefit with plasma but it hasnt published a paper detailing the trials results. The PLATINA trial in Maharashtra met a similar fate.

Emails to researchers involved in both trials hadnt elicited a response at the time of publishing this article.

Not publishing the results of a trial is a breach of the ethical obligations that researchers have towards study participants, and is a grave injustice to our people, Dr Aju Mathew, an epidemiologist and a cancer specialist in Kochi, told The Wire Science.

In a study published in December 2020, Dr Mathew and his peers found that only 55% of cancer trials registered in India were eventually published. They also reported that trials conducted by international pharmaceutical companies were more likely to be published than Indian ones.

Publication bias can have a serious impact on patient care. COVID-19 is a new disease: before drug trials got underway, healthcare workers drew on their experience and education to make informed guesses about treatments to administer. Negative results in this regard can help workers improve their protocols by subtracting bad options.

Indeed, institutions around the world dropped drugs like hydroxychloroquine, lopinavir and ritonavir from their protocols thanks to negative results from the RECOVERY and SOLIDARITY trials.

Also read: A Good Registry Means Accountable Clinical Trials. But Does India Have One?

Poor output

Smaller trials in India have also been less accountable and have operated with little oversight.

The UKs RECOVERY trial recruited around 40,000 participants at 180 sites. The University of Oxford, which is in charge, centrally determined the protocol to follow and the outcomes to watch out for, and used new results from their own study to update their trial1. Both positive and negative results were published.

No such effort has emerged out of India for reasons including bureaucratic lethargy, little collaboration between institutions, lack of autonomy and of incentives, Dr Mathew said. Other experts also mentioned deficient institutional funding and subpar expertise.

We are a nation of band-aid action. We dont plan ahead of time.

We cant wake up in the middle of the pandemic and expect world-class research, said Dr Soumyadeep Bhaumik, co-head of the meta-research and evidence synthesis unit at the George Institute, New Delhi. A research ecosystem develops after years of systematic investment in institutions, expertise and a regulatory framework.

It was only on June 10, 2021, that the Indian Council for Medical Research issued a tender to develop a large, multicentre, adaptive trial platform like RECOVERY.

According to a researcher who worked on a prominent Centre-funded COVID-19 trial in 2020, a serious lack of expertise among participating clinicians also compounded the chronic under-investment. It took a lot of hand-holding and training to get them to appropriately complete the trial, the researcher said.

It can feel both good and bad to know that India is in fact capable of conducting well-designed trials. For example, the PLACID trial, an ICMR-funded enterprise, enrolled 464 patients (calculated to be sufficient power) from April 22 to July 14, 2020, to study the efficacy of convalescent plasma. The results were published as a preprint paper on September 10 and in BMJ a month later.

In another example, as of October 15, 2020, Indian doctors had enrolled 937 Indian participants at several hospitals in the country for the SOLIDARITY trial.

Even when large, centralised trials arent feasible, Dr Bhaumik said a set of core outcome measures could ensure small trials measuring the same things also watch out for the same results.

Here, experts deliberate on and recommend some common patient-centric outcomes for clinicians to use when designing their trials. Adopting these outcomes wouldnt render all trials the same.

They could measure other outcomes as well but using a core outcome set means the results of these small trials can be pooled to inform policy and practice, Dr Bhaumik said. We need to start developing core outcome sets for diseases of significance to our country.

In the time of COVID-19, this duty fell on the ICMRs shoulders, but which is yet to issue any such directions to the many COVID-19 trials happening in the country.

In fact, in the loudest directive the organisation sent forth (and quickly withdrew), its chief Dr Balram Bhargava demanded in July 2020 that hospitals involved in Covaxins clinical trial complete it in just two months, or face the governments music. The results of this trial are yet to be published.

Ronak Borana is a science communicator based in Mumbai. He tweets at @ronaklmno.

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COVID-19: India Has a Habit of Bad Clinical Trials - The Wire Science

Jasper Therapeutics and Aruvant Announce Research Collaboration to Study JSP191, an Antibody-Based Conditioning Agent, with ARU-1801, a Novel Gene…

Posted: at 1:52 am


REDWOOD CITY, Calif. and NEW YORK and BASEL, Switzerland, June 21, 2021 /PRNewswire/ --Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, andAruvant Sciences, a private company focused on developing gene therapies for rare diseases, today announced that they have entered a non-exclusive research collaboration to evaluate the use of JSP191, Jasper's anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent with ARU-1801, Aruvant's investigational lentiviral gene therapy for sickle cell disease (SCD). The objective of the collaboration is to evaluate the use of JSP191 as an effective and more tolerable conditioning agent that can expand the number of patients who can receive ARU-1801, a potentially curative treatment for SCD.

"This research collaboration with Aruvant is the first to use a clinical-stage antibody-based conditioning agent and a novel clinical-stage gene therapy, giving this combination a clear advantage by moving beyond the harsh conditioning agents currently used for gene therapy and establishing this next-generation potentially curative treatment as a leader in sickle cell disease," said Kevin N. Heller, M.D., executive vice president, research and development of Jasper. "Our goal is to establish JSP191 as a potential new standard of care conditioning agent, broadly in autologous gene therapy and allogeneic hematopoietic stem cell transplantation."

Gene therapies and gene editing technologies generally require that a patient's own hematopoietic stem cells first be depleted from the bone marrow to facilitate the engraftment of the new, gene-modified stem cells through a process called conditioning. Other investigational gene therapies and gene editing approaches in SCD use a high-dose chemotherapy such as busulfan for the conditioning regimen, which can place patients at prolonged risk for infection and bleeding, secondary malignancy and infertility. ARU-1801 is currently the only gene therapy that has demonstrated durable efficacy using both a lower dose of chemotherapy and a different agent than busulfan with a more limited side effect profile. The Aruvant-Jasper partnership is focused on evaluating the potential of using JSP191, a highly targeted anti-CD117 (stem cell factor receptor) monoclonal antibody agent, as the foundationof a novel conditioning regimen for use in combination with ARU-1801 to further reduce the negative side effects while maintaining efficacy.

"The unique attributes of ARU-1801 enable us to bring a potentially curative one-time therapy to individuals with sickle cell disease that can be delivered in the safest way possible," said Will Chou, M.D., Aruvant chief executive officer. "By partnering with Jasper to evaluate the use of JSP191 with ARU-1801, we are one step closer to developing a next-generation definitive therapy with an even more patient-friendly conditioning regimen. We believe that this combination may be able to further expand the number of patients who can benefit from ARU-1801 in the future, including potentially those with more moderate disease."

About JSP191JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high dose myeloablative conditioning is associated with severe toxicities and standard low dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. It is currently enrolling in two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) and expects to begin enrollment in four additional studies in 2021 for severe autoimmune disease, sickle cell disease, chronic granulomatous disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

About ARU-1801ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of graft-versus-host disease (GvHD) seen with allogeneic stem cell transplants. Unlike investigational gene therapies and gene editing approaches which require fully myeloablative conditioning, the unique characteristics of ARU-1801 allow it to be given with reduced intensity conditioning ("RIC"). Compared to myeloablative approaches, the lower dose chemotherapy regimen underlying RIC has the potential to reduce not only hospital length of stay, but also the risk of short- and long-term adverse events such as infection and infertility. Preliminary clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial of ARU-1801 in patients with severe sickle cell disease, demonstrate continuing durable reductions in disease burden.

The MOMENTUM StudyAruvant is conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time potentially curative investigational gene therapy for patients with SCD. This Phase 1/2 study is currently enrolling participants, and information may be found at momentumtrials.comwhich includes a patient brochure, an eligibility questionnaireand information for healthcare providers.

About Jasper TherapeuticsJasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, a first-in-class anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic and autologous hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical engineered hematopoietic stem cell (eHSC) platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

About Aruvant SciencesAruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talented team with extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an active research program with a lead product candidate, ARU-1801, in development for individuals suffering from sickle cell disease (SCD). ARU-1801, an investigational lentiviral gene therapy, is being studied in a Phase 1/2 clinical trial, the MOMENTUM study, as a one-time potentially curative treatment for SCD. Preliminary clinical data demonstrate engraftment of ARU-1801 and amelioration of SCD is possible with one dose of reduced intensity chemotherapy. The company's second product candidate, ARU-2801, is in development to cure hypophosphatasia, a devastating, ultra-orphan disorder that affects multiple organ systems and leads to high mortality when not treated. Data from pre-clinical studies with ARU-2801 shows durable improvement in disease biomarkers and increased survival. For more information on the ongoing ARU-1801 clinical study, please visit http://www.momentumtrials.comand for more on the company, please visit http://www.aruvant.com. Follow Aruvant on Facebook, Twitter @AruvantSciencesand on Instagram @Aruvant_Sciences.

About RoivantRoivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants nimble and focused biopharmaceutical and health technology companies. For more information, please visit http://www.roivant.com.

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Adapalene vs Tretinoin: We Break Down The Acne & Aging Powerhouse Ingredients – mindbodygreen.com

Posted: at 1:51 am


Tretinoin is by no means new to skincare. In fact, it was the first FDA-approved retinoid to help treat and prevent acne. Tretinoin is another topical retinoid, derived from vitamin A, that also helps to prevent and treat acne, Libby says. It is more well-studied for its anti-aging benefits and works to increase cell turnover, improving the thickness of the epidermis and minimizing fine lines, while improving discolorations and treating acne, she says.

Unlike adapalene, you cant buy tretinoin over-the-counter. This retinoid is only available by prescription. One of the downsides of tretinoin is the timeline it takes to see results and the possibility of pesky side effects.

For example, if you have sensitive skin, this may not be the retinoid for you. Tretinoin works by irritating further to activate cell turnover, you may experience redness, irritation, blisters, and even a change in skin pigmentation. So, its important to only use this product with the supervision of a doctor. And even with the undesirable side effects, research shows that tretinoin helps to reduce fine lines and wrinkles, correct skin texture and tone and even reduce hyperpigmentation.

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Adapalene vs Tretinoin: We Break Down The Acne & Aging Powerhouse Ingredients - mindbodygreen.com

Could the pandemic help America finally embrace wrinkles? – Vox.com

Posted: at 1:51 am


Consider the wrinkle.

Formed when skin loses elasticity over time, wrinkles are one of the hallmarks of the aging process. Though everyones skin ages differently, almost all of us can expect to see at least a few creases as the years go by.

Despite (or perhaps because of) their universality, wrinkles remain one of the most stigmatized aspects of human appearance: theres a nearly $200 billion industry devoted to smoothing them out, filling them in, and (supposedly) preventing them from cropping up in the first place.

We live in a patriarchal, heterosexist, capitalist society where if wrinkles and signs of aging are held forth as a problem, we can be persuaded to buy shit, Ashton Applewhite, author of the book This Chair Rocks: A Manifesto Against Ageism, told Vox.

The stigma against wrinkles has been remarkably stubborn for example, while a movement toward body positivity and size diversity has led to more brands highlighting models above a size 6 (though not always making larger clothes for actual customers), its still rare to see a wrinkled face in ads, even for brands aimed at older women.

But this might be starting to change, especially since the pandemic has Americans rethinking their relationship to their appearance in all kinds of ways. After letting their roots grow out in lockdown, some are embracing gray hair. Experts are offering advice for accepting changes to our bodies after a traumatic year, including weight gain and aging skin. Celebrities like Katie Couric and Justine Bateman are posing without makeup and making an effort to normalize faces that change with time. And Kate Winslet recently made headlines for insisting that her wrinkles go un-retouched on posters for HBOs Mare of Easttown.

The bias against aging skin has deep roots in American culture, and in some ways seems as entrenched as ever see, for instance, the supposed Zoom boom, a rise in plastic surgery among people tired of looking at their faces on video calls. But the last year has also been a time of rejecting beauty norms that seemed increasingly onerous or pointless, as well as growing awareness around the problems of ageism, as many advocates pushed back on the idea that the elderly and others who were especially vulnerable to Covid-19 were somehow disposable. And after a period of unprecedented trauma, more people may be interested in embracing what wrinkles mean that youve been lucky enough to make it to old age.

The culture is absolutely moving in the right direction, Applewhite said.

Anti-aging treatments are far from new. Cosmetic modifications to the face date back to ancient Egypt, if not earlier, Zakia Rahman, a clinical professor of dermatology at Stanford University, told Vox. Many early treatments involved acids applied to the skin to stimulate collagen production and give a more youthful appearance.

Later, in the 16th and 17th centuries, European women applied meat or wine to their faces in order to smooth out wrinkles (wine maybe kind of worked, according to Pacific Standard). A more drastic measure, the facelift, debuted in the early 1900s: a surgeon would make cuts around the hairline and pull the skin taut, reducing the appearance of wrinkles. Then, in 2002, came a game-changer: Botox was approved for cosmetic use. A toxin produced by bacteria, Botox paralyzes facial muscles, smoothing out wrinkles or even preventing them from forming in the first place.

The history of skin care may one day be divided into its own epochs: B.B. (Before Botox) and A.B. (After Botox), Allure declared in 2007.

But another development may have been even more influential in the history of aging and body image: the smartphone. With the rise of mobile devices and social media, the sheer number of images were exposed to every day has increased dramatically in recent years. Many of these images are carefully curated, with lighting, filters, and in some cases Photoshop, allowing users to present only idealized versions of themselves. But the photos we see, however edited they may be, give us ideas of what is normal and what is beautiful, Rahman said. And oftentimes, we think that these images represent reality.

Ive certainly seen in my practice that more and more people are coming in wanting to look like an image that theyve seen on Instagram or a video they bring on TikTok, Rahman added.

The same distorted reality is evident in Hollywood, where, it seems, only mens faces wrinkle as they age. The double standard is clear in TV shows like 2020s The Undoing, in which Hugh Grant displayed the lined face of a 60-year-old man (he is 60), while Nicole Kidman, 53, appeared preternaturally smooth-skinned. And the onslaught of images like this can lead to pressure to look a certain way as we get older as well as judgment if we dont. Visible signs of aging are held against us, especially women, Applewhite said.

And its not just about critical comments. Older women can face ageism in workplaces and in hiring, with one 2017 study showing that the older a woman was, the less likely she was to hear back from prospective employers about job applications. Given this, its not a shock that many women would fear the tell-tale signs that age leaves on their faces. The discrimination is real, Applewhite said.

In recent years, movements around body positivity have sought to expand definitions of beauty beyond the thin, white, young ideal that so often dominates mainstream fashion and media. Beginning around 2008, for example, body positivity advocates began posting photos, essays, and poetry on Tumblr and Facebook in an effort to normalize being bigger and being happy, or being bigger and just being comfortable in your skin, Stephanie Yeboah, a blogger and author of the book Fattily Ever After: A Black Fat Girls Guide to Living Life Unapologetically. Predominantly led by larger fat Black women, the movement was a safe space for marginalized bodies to come together and celebrate and normalize ourselves, Yeboah said.

Over time, body positivity entered the mainstream, with brands featuring more plus-size models and offering clothes in larger sizes. And that also translated to a more inclusive definition of beauty beyond just size, Yeboah said, as more campaigns began to feature disabled or older models as well. UK retailer Marks & Spencer, for example, has used older women in ads, as have fashion houses Lanvin and Cline (the latter famously featured 80-year-old Joan Didion in a 2015 campaign that quickly went viral).

However, the mainstream embrace of body positivity has its limits. Even when brands use plus-size models, they often choose white or white-passing women with hourglass figures and small stomachs people who are seen as good fat, Yeboah said. Meanwhile, older models used in ad campaigns also tend to be white.

In general, the public conversation around aging and anti-aging has tended to center white people and white skin, as well. In part, thats because of a perception that Black women age less quickly than everybody else, Yeboah said.

Its true that melanin, a pigment present at higher levels in darker skin, provides some protection from sun damage and therefore from winkles. Think of it as an umbrella, Rahman said. Its also true that Black communities and other communities of color have conversations and beliefs around aging and bodies that diverge from the negative messages handed down by mainstream media.

Theres a certain status that is given to older people of color within their communities, Afiya Mbilishaka, a clinical psychologist who studies the psychology of beauty, told Vox. They were able to thrive in this society that often is focused on their demise.

Magazines like Essence and Ebony have often celebrated the beauty of older Black celebrities, Mbilishaka said. Actors Cicely Tyson and Angela Bassett have been especially held up as icons of beautiful aging. And grandmothers have a very particular power status in Black families, she added. We really honor the aging process. We celebrate it. We want people to live a long time.

Still, the exclusion of Black people and other people of color from mainstream conversations around aging remains problematic, Yeboah said. While the idea that Black women dont age or dont worry about aging might sound nice, its still kind of marginalizing and cutting off a demographic of women, she explained.

And even if older women of color are celebrated within their communities, they can face intertwined ageism and racism in mainstream media, which also shows up in society as a whole. In movies and TV, older Black women often show up either in matronly subservient roles as maids or nurses, or harsh disciplinarian roles like police commissioners, Yeboah said. Theyre never really given their moment to really show up for themselves and to live their best lives.

While the body positivity movement provided one opportunity to challenge the stigma around wrinkles, the pandemic may offer another. After all, when lockdowns forced hair salons to close, many women missed their dye appointments and started letting their hair go gray. And while some went back as soon as they could, others decided to stick with their new silver hue. The New Yorker chronicled some of these transformations in a recent photo feature. When I see friends whom I have known since I was thirteen, and they are gray, I think, Wow, we are older, one woman, Sabrina Spencer, told the magazine. But I dont see it as negative.

The trend could be a broader sign of changing attitudes toward visible signs of aging, including wrinkles, Applewhite said: Were not going to allow ourselves to be so tyrannized by them.

Recent months have also seen a number of celebrities and other public figures speak out about embracing older skin. For example, in Face: One Square Foot of Skin, published this April, author and filmmaker (and a star of the 1980s sitcom Family Ties) Justine Bateman explores womens relationships to their wrinkles. Bateman was inspired to write the book after she tried Googling herself and found the search autocompleted to Justine Bateman looks old.

It messed with my head far more than I thought it would, she told Vox. But the experience led her to think about larger social attitudes toward aging: What fears do we have as a group that are acting as anchors for this idea that womens faces are broken and need to be fixed?

Today, her message to readers is that they can interrogate these fears rather than feeling they have to alter their appearance to please someone else. You dont have to go along with this idea that your face is hideous, she said. You have a choice.

Others, too, have recently used their platforms to normalize wrinkles. Katie Couric, for example, posed without makeup for a March spread in People magazine, saying, When we start seeing women as they age and appreciate the beauty that comes with that, women will stop trying to look young all the time. Earlier this month, actress Shannen Doherty posted a makeup-free selfie on Instagram, writing, Watching movies tonight and noticed there were few female characters I could relate to. You know, women without fillers, without Botox, without a facelift.

I have lived, she added. I love that Ive lived and that my face reflects my life.

Kate Winslet sent a similar message in promoting Mare of Easttown, in which she plays an unglamorous middle-aged detective. The actress initially sent a promo poster for the show back because her skin was too retouched, she told the New York Times: Im like Guys, I know how many lines I have by the side of my eye, please put them all back.

Her character, Mare Sheehan, is a fully functioning, flawed woman with a body and a face that moves in a way that is synonymous with her age and her life and where she comes from, Winslet added. I think were starved of that a bit.

Meanwhile, makeup brand Ilia Beauty has been getting attention for featuring older women with visible wrinkles on its Instagram, either on their own or paired with their daughters.

Such moments of wrinkle visibility could be heightened by the current historical moment. Indeed, the pandemic might be changing cultural attitudes around aging and life experiences, encouraging people to celebrate the bodies that have taken them through hard times and shining a bright light on ageism across society. When Covid-19 first began spreading in America, many dismissed it as only afflicting the old and sick, a dismissal that may even have led to worse health care for elderly patients. But now, theres a growing awareness of the role of age discrimination in the pandemic and beyond.

In March, for example, the World Health Organization launched the new Global Campaign to Combat Ageism, which aims to change the narrative around age and ageing and help create a world for all ages.

The pandemic exposed the prejudice that has been all around us all along, Applewhite said. It brought age and aging out of the corner, out of the shadows.

The last year has also been a time when many people reconsidered their priorities, including the time and effort they spend on their appearance. As the stressors and anxieties of the past year mounted, many people became comfortable with long, gray hair, bushy beards, makeup- or Botox-free faces, and extra pounds, clinical psychologist Jelena Kecmanovic wrote in the Washington Post. For some, this went hand-in-hand with a more natural, mindful way of living.

Some people just became less self-conscious about their looks over the last 18 months, Mbilishaka said because its a pandemic, and who cares?

Of course, the pandemic also forced many people to spend their workdays on Zoom, which may have encouraged them to focus on their wrinkles. There was this constant looking at the face, Bateman said. Whens the last time you looked at yourself in the mirror for an hour?

And while getting Botox or forgoing it may be a decision for some people, not everyone has the luxury of choice when it comes to taking care of their skin. Someone who does manual labor outdoors may not be able to avoid the sun, for example, Mbilishaka said. And its important to recognize both the extra income involved in beauty (Botox can cost around $300-$600 per treatment, while fillers can start at more than $650) and the free time needed for anything from getting fillers to applying under-eye cream. Going without such treatments may be empowering for some people for others, its just life.

More than just eschewing certain products, a true shift in the way we see older faces may require a change in how we see older people and their roles. American society needs to really disrupt the concept of aging, Mbilishaka said. Just because someone is retired or not having more children doesnt mean that they cant make such a meaningful contribution.

Beauty publications should not only feature older models (including those with actual wrinkles), but also hire older writers to make sure their experiences with skin care and products are being represented, Yeboah said. Beauty doesnt stop when you are 40.

And while older people arent responsible for ending the stigma against them, they could still have a role to play. If older women continue to, as a group, despise their own faces, all the women that are younger than them are going to be terrified of the second half of their life, Bateman said. But if older women are able to love themselves and their skin, then these younger women are going to look at the older women the same way an 8-year-old looks at a tween, she explained: like, Oh, my God, I cant wait to be 12.

Wouldnt it be more fun if we were always looking forward, going like, I cant wait to be 50. I cant wait to be 60, 70, 80, Bateman said. Im going to be rad like that.

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Could the pandemic help America finally embrace wrinkles? - Vox.com

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