The Week Ahead In Biotech (April 24: April 30): Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA Decisions, Big Pharma Revenue, IPOs, and More

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Biotech stocks extended their losses in the week ending April 22. The sector took signals from the broader market, which reacted to the lackluster start to the first quarter reporting season and lingering fears of rate hikes.

In the field of mergers and acquisitions, Regeneron Pharmaceuticals, Inc. REGN strikes a deal to acquire Checkmate Pharmaceuticals, Inc. CMPI for $250 million.

Johnson & Johnson, Inc. JNJ started the pharma reporting season with mixed results for the first quarter. The company withdrew its COVID-19 vaccine guidelines for the year, citing global supply surplus and demand uncertainty.

Here are the key catalysts for the unfolding week:

Conferences

2022 American Society of Cataract and Refractive Surgery, or ASCRS, Annual Meeting: April 23-26, in Washington, D.C.

2022 Tandem Meetings – American Society for Transplantation and Cellular Therapy, or ASTCT, and Center for International Blood and Marrow Transplant Research, or CIBMTR Transplantation and Cellular Therapy Meetings: April 23-26, in Salt Lake City, Utah

32nd European Congress of Clinical Microbiology and Infectious Diseases, or ECCMID: April 23-26, held virtually in Lisbon, Portugal

American Academy of Neurology, or AAN, Annual Meeting: April 24-26, in Seattle, Washington

The 2022 FDA/DIA Oligonucleotide-based Therapeutics Conference, or Oligo22: April 25-27, in Rockville, Maryland

2022 Combined Otolaryngology Spring Meetings, or COSM: April 27 – May 1 in Dallas, Texas.

PDUFA Dates

The Food and Drug Administration is expected to release its ruling on Bristol-Myers Squibb Company’s new BMY filing for mavacamten for the treatment of heart failure. The decision will be made on Thursday 28 April.

Supernus Pharmaceuticals, Inc.’s SUPN additional new drug application to extend Qelbree’s label to adult patients with ADHD has a PDUFA target date of Friday, April 29.

The FDA will also rule on HUTCHMED (China) Limited’s HCM NDA for surufatinib as a treatment option for pancreatic and extra-pancreatic neuroendocrine tumors. The decision is expected by Saturday, April 30.

Axsome Therapeutics, Inc. AXSM has a Friday PDUFA target date for its NDA for meloxicam-rizatriptan in acute migraine.

The drug regulatory agency is also expected to announce its decision on Coherus BioSciences, Inc.’s CHRS biologics license application. for toripalimab in nasopharynx cancer. The PDUFA target date is Saturday.

Related Link: Attention Biotech Investors: Mark Your Diary for the April PDUFA Dates

Clinical Readings/Presentations

Nkarta, Inc. NKTX is scheduled to hold a conference call Monday at 8 a.m. ET to review clinical data from the Phase 1 clinical trials evaluating two lead clinical programs, NKX101 and NKX019. The former is being evaluated for acute myeloid leukemia/myelodysplastic syndromes and the latter for B-cell malignancies.

Arrowhead Pharmaceuticals, Inc. ARWR will present Phase 1b data for ARO-HIF2 in clear cell renal cell carcinoma at the Oligo22 conference.

Ocuphire Pharma, Inc. OCUP will present Phase 2 data for Nyxol in presbyopia at the ASCRS meeting. (Monday)

Cidara Therapeutics, Inc. CDTX is expected to present Phase 2/3 data for rezafungin in candidaemia at the ECCMID meeting. (Monday)

Magenta Therapeutics, Inc. MGTA will present Phase 2 data for MGTA-145, in combination with plerixafor, in patients with multiple myeloma at the TCT meeting. (Tuesday)

Merck & Company, Inc. MRK will present Phase 3 data for oral COVID-19 Lagevrio, formerly molnupiravir, in COVID-19 patients at the ECCMID meeting.

Lyra Therapeutics, Inc. LYRA will present Phase 2 data for LYR-210 in chronic rhinosinusitis at the COSM meeting. (Thursday)

Tarsus Pharmaceuticals, Inc. TARS expects to release Phase 3 topline data for TP-03 in Demodex blepharitis in April.

Income

The income list presented is not exhaustive. Click here to access Benzinga’s earnings calendar for the full schedule

Tuesday

NeuroMetrix, Inc. NURO (before the market opens)

Wednesday

Boston Scientific Corporation BSX (before the market opens)
Alkermes plc ALKS (before market opening)
Integra LifeSciences Holdings Corporation IART (before the market opens)
Amgen Inc. AMGN (after closing)
BioMarin Pharmaceutical Inc. BMRN (after closing)

Thursday

Merck (before the market opens)
Eli Lilly & Company LLY (before market opens)
Alnylam, Inc. ALNY (before the market opens)

Friday

AbbVie, Inc. ABBV (before the market opens)
Birstol-Myers Squibb (before the market opens)

IPOs

IPO prices

San Diego, California-based Belite Bio, Inc. BLTE, a clinical-stage biopharmaceutical company focused on therapies for retinal disease, has filed to offer 6 million shares in an IPO. This exempt holding company in the Cayman Islands expects to price the offering between $5.50 and $6.50 per ADS. The company has applied to list its ADSs on the Nasdaq.

Tenon Medical, Inc., a medical device company, plans to offer 4 million shares in an IPO, with an estimated price range of $4.50-$5.50 per share. The Los Gatos, California-based company expects to list its shares on the Nasdaq under the ticker symbol TNON.

Related link: Biogen fails to convince European regulatory agency’s benefits of Alzheimer’s drug


This post The Week Ahead In Biotech (April 24: April 30): Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA Decisions, Big Pharma Revenue, IPOs, and More was original published at “https://www.benzinga.com/general/biotech/22/04/26778599/the-week-ahead-in-biotech-april-24-april-30-bristol-myers-squibb-supernus-hutchmed-axsome-coherus”

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