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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. (NASDAQ:REGN) announced a deal to buy Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) for $250 million.
Johnson & Johnson, Inc. (NYSE: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:
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.
The Food and Drug Administration is scheduled to announce its verdict on Bristol-Myers Squibb Company's (NYSE:BMY) new drug application for heart failure treatment mavacamten. The decision is due on Thursday, April 28.
Supernus Pharmaceuticals, Inc.'s (NASDAQ: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 (NASDAQ: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. (NASDAQ: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 (NASDAQ: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
Nkarta, Inc. (NASDAQ: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. (NASDAQ:ARWR) will present at the Oligo22 conference Phase 1b data for ARO-HIF2 in clear cell renal cell carcinoma.
Ocuphire Pharma, Inc. (NASDAQ:OCUP) will present at the ASCRS meeting Phase 2 data for Nyxol in presbyopia. (Monday)
Cidara Therapeutics, Inc. (NASDAQ:CDTX) is scheduled to present at the ECCMID meeting Phase 2/3 data for rezafungin in candidemia. (Monday)
Magenta Therapeutics, Inc. (NASDAQ: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. (NYSE: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. (NASDAQ:LYRA) will present at the COSM meeting Phase 2 data for LYR-210 in chronic rhinosinusitis. (Thursday)
Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS) expects to release Phase 3 topline data for TP-03 in Demodex blepharitis in April.
The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule
Tuesday
NeuroMetrix, Inc. (NASDAQ:NURO) (before the market open)
Wednesday
Boston Scientific Corporation (NYSE:BSX) (before the market open)
Alkermes plc (NASDAQ:ALKS) (before the market open)
Integra LifeSciences Holdings Corporation (NASDAQ:IART) (before the market open)
Amgen Inc. (NASDAQ:AMGN) (after the close)
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) (after the close)
Thursday
Merck (before the market open)
Eli Lilly & Company (NYSE:LLY) (before the market open)
Alnylam, Inc. (NASDAQ:ALNY) (before the market open)
Friday
AbbVie, Inc. (NYSE:ABBV) (before the market open)
Birstol-Myers Squibb (before the market open)
IPO Pricing
San Diego, California-based Belite Bio, Inc. (NASDAQ: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. (NASDAQ: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: ABBV ALKS ALNY AMGN ARWR AXSM BLTE BMRN BMY BSX CDTX CHRS CMPI HCM IART IBB JNJ LLY LYRA MGTA
