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

Zinger Key Points
  • The upcoming week's calendar is heavy, loaded with a slew of FDA decisions and data readouts
  • Big pharma earnings picks up pace and IPO news flow is also in the mix

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

On the M&A front, Regeneron Pharmaceuticals, Inc. REGN announced a deal to buy Checkmate Pharmaceuticals, Inc. CMPI for $250 million.

Johnson & Johnson, Inc. JNJ kickstarted the pharma reporting season with mixed first-quarter results. The company withdrew its COVID-19 vaccine guidance 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 – Transplantation & Cellular Therapy Meetings Of American Society for Transplantation and Cellular Therapy, or ASTCT, and Center for International Blood and Marrow Transplant Research, or CIBMTR: April 23-26, in Salt Lake City, Utah

32nd European Congress of Clinical Microbiology and Infectious Diseases, or ECCMID: April 23-26, being held virtually and 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 scheduled to announce its verdict on Bristol-Myers Squibb Company's BMY new drug application for heart failure treatment mavacamten. The decision is due on Thursday, April 28.

Supernus Pharmaceuticals, Inc.'s SUPN supplemental new drug application to expand the label of Qelbree to include adult patients with attention deficit hyperactivity disorder has a PDUFA goal date of Friday, April 29.

The FDA is also scheduled to 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 PDUFA goal date of Friday for its NDA for meloxicam-rizatriptan in acute migraine.

The drug regulator is also expected to announce its decision on Coherus BioSciences, Inc.'s CHRS biologic license application for toripalimab in nasopharyngeal cancer. The PDUFA goal date is Saturday.

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Clinical Readouts/Presentations

Nkarta, Inc. NKTX is scheduled to host a conference call on Monday, at 8 am ET, to review clinical data from the Phase 1 clinical trials assessing 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 at the Oligo22 conference Phase 1b data for ARO-HIF2 in clear cell renal cell carcinoma.

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

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

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

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

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

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

Earnings

The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule

Tuesday

NeuroMetrix, Inc. NURO (before the market open)

Wednesday

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

Thursday

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

Friday

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

IPOs

IPO Pricing

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

Medical device company Tenon Medical, Inc. TNON plans to offer 4 million shares in an IPO, with the estimated price range at $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 Benefits Of Alzheimer's Drug To European Regulator

Posted In: BiotechEarningsNewsFDAIPOsGeneral