Biotech stocks continued to slide for a second straight week as risk aversion continued to pressure stocks amid geopolitical tensions and macro concerns.
From a regulatory perspective, the Food and Drug Administration has approved Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) mitapivat for the treatment of pyruvate kinase deficiency, a rare inherited metabolic disorder.
Avenue Therapeutics, Inc. (NASDAQ: ATXI) Shares fell nearly 60% after an FDA panel found that data included in the company’s New Drug Application for the painkiller tramadol was insufficient to support the approval.
GlaxoSmithKline plc (NYSE:GSK) and Sanofi (NASDAQ: SNY)-Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) suffered setbacks after their respective late-stage studies of the respiratory syncytial vaccine candidate in pregnant women and Dupixent as a rash treatment option had to be halted.
Here are the main catalysts for the week that is unfolding:
Conferences
American Auditory Society’s 49th Annual Science and Technology Meeting, AAS (Hybrid Event) – February 24-27, in Scottsdale, Arizona and online
Multidisciplinary Head and Neck Cancer Symposium (virtual event): February 24-27, in Phoenix, Arizona and online
International Society of Nephrology, or WCN, World Congress of Nephrology, 2022 (Hybrid Event): February 24-27, in Kuala Lumpur and online
PDUFA Dates
The FDA has set a PDUFA date of Friday, February 25 for its new drug application for Reata Pharmaceuticals, Inc. (NASDAQ: RETA) Bardoxolone. The investigational compound is a drug taken orally once a day that is being evaluated as a treatment option for Alport syndrome, a rare genetic form of chronic kidney disease caused by mutations in genes.
Clinical readings/presentations
Chinook Therapeutics, Inc. (NASDAQ: KDNY) is set to report top results from the Phase 1/2 study of BION-1301 in patients with IgA nephropathy to WCN.
Otonomy, Inc. (NASDAQ: OTIC) to Present Data from Phase 1/2 Study of Eurotrophin OTO-413 for Hearing Loss at AAS Meeting (Thursday)
PDS Biotechnology Company (NASDAQ: PDSB) will present early safety data from its VERSATILE-002 study at the Multidisciplinary Head and Neck Cancer Symposium. The study evaluates the company’s PDS0101 in combination with Merck & Co., Inc. (NYSE: MRK) keytruda for the treatment of recurrent or metastatic HPV16 positive head and neck cancer.
Earnings
The list of prizes presented is not exhaustive. Click here to access Benzinga’s earnings schedule for the full schedule.
Tuesday
Esperion Therapeutics, Inc. (NASDAQ: ESPR) (before market open)
Medtronic plc (NYSE: MDT) (before market open)
Society of Exact Sciences (NASDAQ: EXAS) (after closing)
Glaukos Corporation (NYSE: GKOS) (after closing)
Penumbra, Inc. (NYSE: PEN) (after closing)
PTC Therapeutics, Inc. (NASDAQ: PTCT) (after closing)
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after close)
Tandem Diabetes Care, Inc. (NASDAQ: TNDM) (after closing)
Related Link: Needham Upgrades Masimo to Buy, with Price Target of $205
Wednesday
Avanos Medical, Inc. (NYSE: AVNS) (before market open)
Bausch Health Companies Inc. (NYSE: BHC) (before market open)
NeoGenomics, Inc. (NASDAQ: NEO) (before market open)
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) (after market close)
Fulgent Genetics, Inc. (NASDAQ: FLGT) (after market close)
Global Blood Therapeutics, Inc. (NASDAQ: GBT) (after market close)
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after market close)
Guardant Health, Inc. (NASDAQ: GH) (after market close)
Inari Medical, Inc. (NASDAQ: NARI) (after market close)
Island Corporation (NASDAQ: PODD) (after market close)
iRhythm Technologies, Inc. (NASDAQ: IRTC) (after market close)
Maravai LifeSciences Holdings, Inc. (NASDAQ: MRVI) (after market close)
NuVasive, Inc. (NASDAQ: NUVA) (after market close)
Nevro Corp. (NYSE: NVRO) (after market close)
Thursday
Agios (before market opening)
Editas Medicine, Inc. (NASDAQ: EDIT) (before market open)
Moderna, Inc. (NASDAQ: MRNA) (before market open)
Pacira BioSciences, Inc. (NASDAQ: PCRX) (before market open)
Sage Therapeutics, Inc. (NASDAQ: SAGE) (before market open)
Vericel Corporation (NASDAQ: VCEL) (before market open)
AbCellera Biologics Inc. (NASDAQ: ABCL) (after market close)
CareDx, Inc. (NASDAQ: CDNA) (after market close)
Axonics, Inc. (NASDAQ: AXNX) (after market close)
Collegium Pharmaceutical, Inc. (NASDAQ: COLL) (after market close)
Emergent BioSolutions Inc. (NYSE: EBS) (after market close)
Codexis, Inc. (NASDAQ: CDXS) (after market close)
ICU Medical, Inc. . (NASDAQ: ICUI) (after market close)
Invitee Corporation (NYSE: NVTA) (after market close)
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) (after market close)
Merit Medical Systems, Inc. (NASDAQ: MMSI) (after market close)
LeMaitre Vascular, Inc. (NASDAQ: LMAT) (after market close)
MacroGenics, Inc. (NASDAQ: MGNX) (after market close)
Natera, Inc. (NASDAQ: NTRA) (after market close)
OPKO Health, Inc. (NASDAQ: OPK) (after market close)
Sangamo Therapeutics, Inc. (NASDAQ: SGMO) (after market close)
Medical Silk Road, Inc. (NASDAQ: SILK) (after market close)
Travere Therapeutics, Inc. (NASDAQ: TVTX) (after market close)
Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB)
Vir Biotechnology, Inc. (NASDAQ: VIR) (after market close)
Friday
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (before market open)
ImmunoGen, Inc. (NASDAQ: IMGN) (before market open)
Related Link: 2 Natural Killer Cell Therapy Oncology Companies Investors Should Watch
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