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Tuesday, January 3, 2023

Vaxcyte Top Pick at Needham

 

  • Vaxcyte Inc  is Needham's top pick for 2023 and has been added to the Needham Conviction list and raised the price target to $58 from $52.
  • The analyst writes that the positive initial VAX-24 Phase 1/2 results in October 2022 significantly de-risked the company's VAX-24 Pneumococcal Conjugate Vaccine (PCV) lead program, thus increasing conviction for a similarly optimistic outcome for the upcoming initial Phase 1/2 data readout in adults 65+ y/o in 1H23. 
  • The analyst sees an upside into the $55-60/share range if the Phase 1/2 64+ y/o results are positive.
  • With a significant Pharma interest in the Pneumococcal Vaccine space (over $7 billion market dominated by Pfizer Inc's  Prevnar) and analyst views that VAX-24 has a potential best-in-class profile make PCVX a compelling M&A target. 
  • Needham models the Pneumococcal Vaccine market to reach around $11.7 billion by 2038. The base case assumes VAX-24/XP captures ~50% of the market at peak, with $6.1 billion in global sales.

Investor Group to Vote AGAINST Sesen Bio Merger with Carisma

 Proposes Alternative to the Merger That Would Deliver Superior Value for Sesen Bio’s Stockholders

Questions the Sesen Bio Board’s Resistance to Obtaining a New Fairness Opinion for Carisma Now That Comparable Companies Have Declined 30%-60% Since the Merger Announcement

https://finance.yahoo.com/news/investor-group-reiterates-intent-vote-130000302.html

Vera: Positive Topline Results of Phase 2bl Trial of Atacicept for IgA Nephropathy

 Atacicept met primary endpoint at 24 weeks, and also achieved statistical significance in the 150 mg dose group with a 33% mean reduction in proteinuria from baseline, with available data showing trend towards further reductions in proteinuria at week 36

Atacicept safety profile in IgAN patients was similar to placebo

Vera plans to advance atacicept into a pivotal Phase 3 trial in the first half of 2023

Company to host investor conference call and webcast on January 4, 2023, at 8:00 a.m. ET to further discuss results

Conference Call / Webcast Details
Vera will host a conference call and webcast with slide presentation at 8:00 a.m. ET on January 4, 2023. The live webcast will be available here, and on the Events & Presentations page of the Vera website, with the recording and presentation available immediately following the event.

https://finance.yahoo.com/news/vera-therapeutics-announces-positive-topline-210100527.html

Health Catalyst cut to In Line from Outperform by Evercore

 Target to $11 from $10

https://finviz.com/quote.ashx?t=HCAT&ty=c&ta=1&p=d

Novo: Weight loss drug Wegovy available to retail pharmacies nationwide after shortages

 Novo Nordisk, the maker of weight loss drug Wegovy, said the medication that faced a nationwide shortage due to a rise in popularity on social media is now available to all retail pharmacies in the U.S.

The Danish multinational pharmaceutical company – which also suffered supply constraints with its diabetes-related drug Ozempic – said that all dose strengths of Wegovy are now available after the company faced supply constraints due to unprecedented product demand and short-term manufacturing issues.

The company said in a statement to FOX Business that it "worked through supply challenges" and is increasing production capacity in 2023 while "closely monitoring prescribing trends and assessing demand." 

It is a sigh of relief for doctors who were left "scrambling to find alternative medicines that don't exist," according to gastroenterologist and obesity medicine specialist Dr. Christopher McGowan. 

"This is extremely positive for the field because we've been waiting for many, many months for the availability of Wegovy… which has been immensely frustrating for medical providers and patients alike," McGowan told FOX Business. "We have this incredibly effective medicine, and we just simply couldn't prescribe it," he added. 

The pharmaceutical company said it may still "experience normal delays given the time required to order the product from their local distribution center, and geographical variabilities." It is also still "experiencing intermittent supply disruptions" for certain doses of Ozempic "due to the combination of incredible demand coupled with overall global supply constraints." 

McGowan cautioned that patients resuming Wegovy need to start at the lowest dose again. If patients start where they left off, they can face significant side effects.

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While Wegovy and Ozempic are the same medication – semaglutide – they have different dosages and FDA-approved intended uses. 

Both drugs surged in popularity last year after celebrities and other high-profile figures – including Elon Musk – touted their effects as a weight loss treatment. Novo Nordisk said neither drug is "intended to be used as a lifestyle medication."

Ozempic was approved by federal health officials in 2017 and marketed for medical use in the treatment of Type 2 diabetes "with weight loss as a secondary effect of the drug’s effects and mechanism of action." 

Meanwhile, Wegovy was approved four years later specifically for chronic weight management in adults who are obese or overweight and that have at least one weight-related condition such as high blood pressure, Type 2 diabetes or high cholesterol, according to the Food and Drug Administration. 

In October, Novo Nordisk announced that it was dealing with supply disruptions on various doses of Ozempic. 

TickerSecurityLastChangeChange %
NVONOVO NORDISK A/S137.00+1.68+1.24%

The issue is that as Wegovy started to become less readily available, medical professionals started to see "the off-label use of Ozempic for weight loss which is not what it's indicated for," according to McGowan.

This, in turn, began to pose risks for patients with diabetes and who needed the medicine.

https://www.foxbusiness.com/lifestyle/weight-loss-drug-wegovy-available-retail-pharmacies-nationwide-after-shortages

Universal Health upped to Equal Weight from Underweight by Wells Fargo

 Target $154 from $113

https://finviz.com/quote.ashx?t=UHS&ty=c&ta=1&p=d

Arvinas cut to Equal Weight from Overweight by Wells Fargo

 Target to $49 from $83

https://finviz.com/quote.ashx?t=ARVN&ty=c&ta=1&p=d