The Week Ahead In Biotech (Feb. 20-26): Reata Awaits FDA Decision, Bausch Health, Moderna Lead Earnings News Flow

Biotech stock extended lower for a second straight week as risk aversion continued to pressure stocks amid geopolitical tensions and macroeconomic worries.

On the regulatory front, the Food and Drug Administration approved Agios Pharmaceuticals, Inc.'s (NASDAQ:AGIO) mitapivat for treating pyruvate kinase deficiency, a rare, inherited metabolic disorder.

Avenue Therapeutics, Inc. (NASDAQ:ATXI) stock tumbled close to 60% after an FDA panel found that data included in the company's new drug application for pain drug tramadol was inadequate to support approval.

GlaxoSmithKline plc (NYSE:GSK) and Sanofi (NASDAQ:SNY)-Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) suffered setbacks after their respective late-stage studies of respiratory syncytial vaccine candidate in pregnant women and Dupixent as a treatment option for skin rash had to be halted.

Here are the key catalysts for the unfolding week:

Conferences

49th Annual Scientific and Technology Meeting of the American Auditory Society, AAS (hybrid event) – Feb. 24-27, in Scottsdale, Arizona & online

Multidisciplinary Head and Neck Cancers Symposium (virtual event): Feb. 24-27, in Phoenix, Arizona & online

International Society of Nephrology's World Congress of Nephrology, or WCN, 2022 (hybrid event): Feb. 24-27, in Kuala Lumpur & online

PDUFA Dates

The FDA has set a PDUFA date of Friday, Feb. 25, for its new drug application for Reata Pharmaceuticals, Inc.'s (NASDAQ:RETA) Bardoxolone. The investigational compound is a once-daily, orally administered drug 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 Readouts/Presentations

Chinook Therapeutics, Inc. (NASDAQ:KDNY) is due to release at the WCN initial results from the Phase 1/2 study of BION-1301 in patients with IgA nephropathy.

Otonomy, Inc. (NASDAQ:OTIC) is scheduled to present at the AAS meeting data from the Phase 1/2 study of eurotrophin OTO-413 for hearing loss (Thursday)

PDS Biotechnology Corporation (NASDAQ:PDSB) will present at the Multidisciplinary Head and Neck Cancers Symposium, initial safety data from its VERSATILE-002 study. The study is evaluating the company's PDS0101 in combination with Merck & Co., Inc.'s (NYSE:MRK) keytruda for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

Earnings

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

Tuesday

Esperion Therapeutics, Inc. (NASDAQ:ESPR) (before the market open)
Medtronic plc (NYSE:MDT) (before the market open)
Exact Sciences Corporation (NASDAQ:EXAS) (after the close)
Glaukos Corporation (NYSE:GKOS) (after the close)
Penumbra, Inc. (NYSE:PEN) (after the close)
PTC Therapeutics, Inc. (NASDAQ:PTCT) (after the close)
Halozyme Therapeutics, Inc. (NASDAQ:HALO) (after the close)
Tandem Diabetes Care, Inc. (NASDAQ:TNDM) (after the close)

Related Link: Needham Upgrades Masimo To Buy, With Price Target Of $205

Wednesday

Avanos Medical, Inc. (NYSE:AVNS) (before the market open)
Bausch Health Companies Inc. (NYSE:BHC) (before the market open)
NeoGenomics, Inc. (NASDAQ:NEO) (before the market open)
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) (after the market close)
Fulgent Genetics, Inc. (NASDAQ:FLGT) (after the market close)
Global Blood Therapeutics, Inc. (NASDAQ:GBT) (after the market close)
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) (after the market close)
Guardant Health, Inc. (NASDAQ:GH) (after the market close)
Inari Medical, Inc. (NASDAQ:NARI) (after the market close)
Insulet Corporation (NASDAQ:PODD) (after the market close)
iRhythm Technologies, Inc. (NASDAQ:IRTC) (after the market close)
Maravai LifeSciences Holdings, Inc. (NASDAQ:MRVI) (after the market close)
NuVasive, Inc. (NASDAQ:NUVA) (after the market close)
Nevro Corp. (NYSE:NVRO) (after the market close)

Thursday

Agios (before the market open)
Editas Medicine, Inc. (NASDAQ:EDIT) (before the market open)
Moderna, Inc. (NASDAQ:MRNA) (before the market open)
Pacira BioSciences, Inc. (NASDAQ:PCRX) (before the market open)
Sage Therapeutics, Inc. (NASDAQ:SAGE) (before the market open)
Vericel Corporation (NASDAQ:VCEL) (before the market open)
AbCellera Biologics Inc. (NASDAQ:ABCL) (after the market close)
CareDx, Inc (NASDAQ:CDNA) (after the market close)
Axonics, Inc. (NASDAQ:AXNX) (after the market close)
Collegium Pharmaceutical, Inc. (NASDAQ:COLL) (after the market close)
Emergent BioSolutions Inc. (NYSE:EBS) (after the market close)
Codexis, Inc. (NASDAQ:CDXS) (after the market close)
ICU Medical, Inc. . (NASDAQ:ICUI) (after the market close)
Invitae Corporation (NYSE:NVTA) (after the market close)
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) (after the market close)
Merit Medical Systems, Inc. (NASDAQ:MMSI) (after the market close)
LeMaitre Vascular, Inc. (NASDAQ:LMAT) (after the market close)
MacroGenics, Inc. (NASDAQ:MGNX) (after the market close)
Natera, Inc. (NASDAQ:NTRA) (after the market close)
OPKO Health, Inc. (NASDAQ:OPK) (after the market close)
Sangamo Therapeutics, Inc. (NASDAQ:SGMO) (after the market close)
Silk Road Medical, Inc (NASDAQ:SILK) (after the market close)
Travere Therapeutics, Inc. (NASDAQ:TVTX) (after the market close)
Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB)
Vir Biotechnology, Inc. (NASDAQ:VIR) (after the market close)

Friday

Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) (before the market open)
ImmunoGen, Inc. (NASDAQ:IMGN) (before the market open)

Related Link: 2 Natural-Killer Cell Therapy Oncology Companies Investors Should Watch