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 AGNVS, Johnson & Johnson JNJ and Eli Lilly And Co LLY all in the mix.

Coronavirus vaccine and treatment news flow abounded in the week. J&J and Novavax, Inc. NVAX released top-line results from their respective late-stage vaccine studies. Merck & Co., Inc. MRK, meanwhile, dropped out of the vaccine race.

Lilly and Vir Biotechnology Inc VIR announced a study combining their COVID-19 antibody treatments.

Biogen Inc 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 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 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 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 VXRT is expected to release data from the Phase 1 study of its oral COVID-19 vaccine candidate.

Earnings

Monday

Omnicell, Inc. OMCL
Vertex Pharmaceuticals Incorporated VRTX (after the market close)

Tuesday

Bio-Techne Corp TECH (before the market open)
Catalent Inc CTLT (before the market open)
Haemonetics Corporation HAE (before the market open)
Pfizer Inc. PFE (before the market open)
Amgen, Inc. AMGN (after the market close)

Wednesday

AbbVie Inc ABBV (before the market open)
Biogen (before the market open)
Ligand Pharmaceuticals Inc. LGND (before the market open)
Boston Scientific Corporation BSX (before the market open)
Cardiovascular Systems Inc CSII (after the market close)

Thursday

Alexion Pharmaceuticals, Inc. ALXN (before the market open)
Baxter International Inc BAX (before the market open)
Bristol-Myers Squibb Co BMY
Brainstorm Cell Therapeutics Inc BCLI (before the market open)
Quest Diagnostics Inc DGX (before the market open)
Twist Bioscience Corp TWST (after the market close)
Neurocrine Biosciences, Inc. NBIX (after the market close)
Misonix Inc MSON (after the market close)
Gilead Sciences, Inc. GILD (after the market close)

Friday

Meridian Bioscience, Inc. VIVO (before the market open)
Zimmer Biomet Holdings Inc ZBH (before the market open)
Regeneron Pharmaceuticals Inc 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 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