The Week Ahead In Biotech: Merck, Pfizer In Earnings Mix, Plus Adamas, Mallinckrodt FDA Decisions, IPOs And More
Biotech stocks alternated between gains and losses in the week ended Jan. 29 before ending lower. Big pharma earnings season kick started, with Novartis AG(NYSE: NVS), Johnson & Johnson (NYSE: JNJ) and Eli Lilly And Co (NYSE: LLY) all in the mix.
Coronavirus vaccine and treatment news flow abounded in the week. J&J and Novavax, Inc. (NASDAQ: NVAX) released top-line results from their respective late-stage vaccine studies. Merck & Co., Inc. (NYSE: MRK), meanwhile, dropped out of the vaccine race.
Lilly and Vir Biotechnology Inc (NASDAQ: VIR) announced a study combining their COVID-19 antibody treatments.
Biogen Inc (NASDAQ: BIIB) reacted with a move to the upside after the Food and Drug Administration extended the review period of its Alzheimer’s drug, aducanumab, by three months.
Here are the key catalytic events for the unfolding week:
Conferences
Canaccord Genuity’s “New Paradigms & Treatment Approaches in Mental Health” conference: Feb. 3-4
PDUFA Dates
The FDA is scheduled to announce its verdict on Adamas Pharmaceuticals Inc‘s (NASDAQ: ADMS) new drug application for Gocovri as a treatment option for “off episodes” in Parkinson’s disease patients receiving levodopa-based therapy. The decision is due Monday, Feb. 1.
The agency will also decide on Mallinckrodt PLC‘s (OTC: MNKKQ) biologics license application for StrataGraft, an engineered tissue designed to mimic natural human skin, with both inner dermis-like and outer epidermis-like layers. StrataGraft is being evaluated as a treatment option for deep partial-thickness thermal burns. The PDUFA goal date is Tuesday, Feb. 2.
Related Link: Pharma Stock Ideas: Why BMO Is Recommending Regeneron, Constellation
Clinical Readouts
Turning Point Therapeutics Inc (NASDAQ: TPTX) will present at the IASLC World Conference On Lung Cancer updated data from the TRIDENT-1 study of its lead candidate repotrectinib in TKI-naive patients with ROS1-positive advanced non-small cell lung cancer (Sunday, Jan. 31).
Vaxart Inc (NASDAQ: VXRT) is expected to release data from the Phase 1 study of its oral COVID-19 vaccine candidate.
Earnings
Monday
Omnicell, Inc. (NASDAQ: OMCL)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the market close)
Tuesday
Bio-Techne Corp (NASDAQ: TECH) (before the market open)
Catalent Inc (NYSE: CTLT) (before the market open)
Haemonetics Corporation (NYSE: HAE) (before the market open)
Pfizer Inc. (NYSE: PFE) (before the market open)
Amgen, Inc. (NASDAQ: AMGN) (after the market close)
Wednesday
AbbVie Inc (NYSE: ABBV) (before the market open)
Biogen (before the market open)
Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (before the market open)
Boston Scientific Corporation (NYSE: BSX) (before the market open)
Cardiovascular Systems Inc (NASDAQ: CSII) (after the market close)
Thursday
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (before the market open)
Baxter International Inc (NYSE: BAX) (before the market open)
Bristol-Myers Squibb Co (NYSE: BMY (before the market open)
Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI) (before the market open)
Quest Diagnostics Inc (NYSE: DGX) (before the market open)
Twist Bioscience Corp (NASDAQ: TWST) (after the market close)
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) (after the market close)
Misonix Inc (NASDAQ: MSON) (after the market close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the market close)
Friday
Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open)
Zimmer Biomet Holdings Inc (NYSE: ZBH) (before the market open)
Regeneron Pharmaceuticals Inc (NASDAQ: REGN) (before the market open)
IPOs
Blacksburg, Virginia-based Landos Biopharma, Inc. has filed for an initial public offering of 6.25-million shares priced between $15 and $17 each. This clinical-stage biopharma develops oral therapeutics for patients with autoimmune diseases. It is expected to list its shares on the Nasdaq under the ticker symbol LABP.
Danish AI-immunology platform company Evaxion Biotech A/S is offering 2.75 million ADSs in an IPO, with each ADS representing one ordinary share. The company estimates a price range of $10-$12 for the offering. The company has applied for listing its shares on the Nasdaq under the ticker symbol EVAX.
Sana Biotechnology, Inc. is developing in-vivo and ex-vivo cell engineering platforms for developing treatments for a wide range of diseases. The company proposes to offer 15 million shares in an IPO, with an estimated price range of $20-$23. The Seattle-based company has applied for listing its shares on the Nasdaq under the ticker symbol SANA.
IPO Quiet Period Expiries
Gracell Biotechnologies Inc (NASDAQ: GRCL)
Other Events
Johnson & Johnson could file for emergency use authorization approval in the U.S. in the coming week. The company said in a release announcing topline results from the Phase 3 study of its vaccine candidate that an EUA filing will be done in early February.
Related Link: Lilly Awash In Catalysts, Pipeline Updates, Mizuho Says In Upgrade
See more from Benzinga
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
