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Friday, January 27, 2023

Novavax Jumps After Pledging To Update Its Covid Shot; Pfizer, Moderna Slip

 Novavax (NVAX) plans to update its Covid shot for new variants, and NVAX stock outperformed its vaccine rivals on Friday.

The decision follows an advisory committee meeting at the Food and Drug Administration. A panel of independent experts voted unanimously in support of yearly Covid booster shots. They also voted to harmonize strain selection among vaccine makers. This would put Pfizer (PFE) with partner BioNTech (BNTX), Moderna (MRNA) and Novavax on the same page when it comes to selecting the right targets for their updated boosters.

The panelists favored an aggressive timeline for strain selection to booster launch. Experts would pick the strain target in May or June with a goal of launching the updated boosters in September.

"These timelines favor mRNA (messenger RNA) manufacturers, given their speed advantage," SVB Securities analyst Daina Graybosch said in a note to clients.

But in early trading on today's stock market, vaccine stocks Pfizer and Moderna edged lower while NVAX stock and BioNTech shares edged higher. Novavax stock rose 2% near 11.20.

NVAX Stock: Another Vaccine Option

Novavax emphasized the benefit of offering people choices for Covid vaccines. The company uses a protein-based platform, which differs from its rivals' messenger RNA shots. Novavax's approach could garner acceptance from people hesitant to receive vaccines using the newer messenger RNA technology.

"Offering vaccine choices — and ensuring continuous access to those choices — must be at the center of any strategy to protect public health against Covid-19," Novavax's Chief Communications Officer Silvia Taylor said in a written statement.

During the meeting, Novavax leaned in favor of a longer lead-time to update the vaccines, SVB's Graybosch said. She doesn't have a rating on NVAX stock.

"Novavax argued that their platform has greater breadth in variant coverage, allowing for less-frequent strain changes," she said. "They also stated their preference to follow the influenza model more closely with strain recommendation by the end of the first quarter to ensure adequate time for them to build supply for the upcoming season."

Vaccine Stocks All Face Pressure

NVAX stock peaked in February 2021 and has since skidded precipitously. Despite winning myriad new authorizations for its vaccine, the company is facing the same decline in demand as other vaccine makers. Other vaccine stocks have also felt pressure.

Graybosch, the SVB analyst, said the FDA panelists' vote on Thursday is a small boon for vaccine makers. But what's really necessary is a change in public perception, she said.

"It is not yet clear to us that harmonization of vaccine composition or evidence that the bivalent (updated) boosters provide meaningful protection against death, hospitalization, and even symptomatic infection will be sufficient to shift behavior," Graybosch said.

In the U.S., updated vaccines from Pfizer/BioNTech and Moderna are available to all people age 6 months and older. These vaccines are bivalent, meaning they target multiple strains of the virus.

Currently, the strains they target are no longer dominant in the country. Less than 16% of all people have gotten an updated Covid booster.

https://www.investors.com/news/technology/nvax-stock-outperforms-vaccine-stock-rivals-on-pledge-to-update-covid-vaccine/

Akero upped to Overweight from Equal Weight by Morgan Stanley

 Target to $65 from $40

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

FDA approves Eli Lilly's blood cancer drug

 Eli Lilly and Co said on Friday the U.S. health regulator approved its drug for the treatment of a rare form of blood cancer.

The Food and Drug Administration gave accelerated approval to Jaypirca for the treatment of adults mantle cell lymphoma after at least two lines of therapy.

The approval is based on data from a subset of patients from early- to mid-stage trial. The confirmatory late-stage trial is currently enrolling patients, the U.S. drugmaker added.

The drug is expected to be available in the United States in the coming weeks, the company said.

https://finance.yahoo.com/news/1-fda-approves-eli-lillys-192707812.html

Cabaletta upped to Overweight from Equal Weight by Morgan Stanley

 Target to $16 from $3

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

Quince Sells Legacy Protease Inhibitor Portfolio

 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biopharmaceutical company advancing innovative precision therapeutics targeting debilitating and rare diseases, announced the sale of the company’s legacy small molecule protease inhibitor portfolio, including COR588, COR388, COR852, and COR803, pursuant to an asset purchase agreement with Lighthouse Pharmaceuticals, Inc., an entity co-founded by Casey Lynch, former chief executive officer of Quince’s predecessor company Cortexyme.

Lead compound COR588 is a selective, oral small molecule inhibitor of lysine-gingipain that is Phase 2 ready for further evaluation in the treatment of Alzheimer’s disease with mild to moderate dementia and biomarker evidence of P. gingivalis infection. Precision targeting of gingipains with small molecule inhibitors represents an innovative therapeutic approach to addressing P. gingivalis, a bacterium associated with dementia and other degenerative and inflammatory disorders.

Highlights of the asset purchase agreement include:

  • Lighthouse gains exclusive rights to develop, manufacture, and commercialize Quince’s legacy protease inhibitor portfolio globally;

  • Protease inhibitor portfolio includes lysine- and arginine-gingipain inhibitors COR588, COR388, COR852, in addition to COR803, which is a coronavirus 3CLpro targeted program with demonstrated in vivo efficacy;

  • Potential for Quince to receive up to $150 million in regulatory and commercial milestones payments on a product-by-product basis, subject to conditions in the agreement;

  • Potential tiered royalty rates on a product-by-product basis ranging from high single-digit to mid-teens of annual net sales related to the two existing clinical stage programs, and low single-digit royalties for the preclinical programs, subject to conditions in the agreement;

  • Share of sublicense income or acquisition value of clinical and preclinical assets on a product-by-product basis; and

  • Quince to receive a 7.5% ownership stake of Lighthouse Common stock with anti-dilution through the first $10 million raised.

Quince expects to benefit from the reduction of more than $500,000 of annualized expenses associated with the operational and financial support of these protease inhibitor assets.

https://finance.yahoo.com/news/quince-therapeutics-completes-sale-legacy-130000851.html

Compass started at Buy by Stifel

 Target $9

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

J&J, Legend: Blood cancer drug improves progression-free survival

  Johnson & Johnson said on Friday an interim analysis showed its drug Carvykti met the main goal of improving progression-free survival in patients with a type of blood cancer in a late-stage study.

The company is testing Carvykti in multiple myeloma patients, with a history of relapse, who have stopped responding to existing treatment and have received one to three prior therapies.

Carvykti, developed by J&J and its China-focused partner Legend Biotech Corp, was approved by the U.S. health regulator last year based on an early-to mid-stage study to treat relapsed or refractory multiple myeloma patients who had received four or more prior lines of therapy.

U.S.-listed shares of Legend Biotech were up 2% in early trading.

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, found in the bone marrow. J&J estimates more than 35,000 people to be diagnosed with the disease in 2023.

Carvykti belongs to a class of drugs known as CAR-T therapies that work by harvesting a patient's own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.

https://finance.yahoo.com/news/1-j-j-says-blood-145402930.html