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 AGIO mitapivat for treating pyruvate kinase deficiency, a rare, inherited metabolic disorder.

Avenue Therapeutics, Inc. 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 GSK and Sanofi SNY-Regeneron Pharmaceuticals, Inc. 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 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. 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. 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 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 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. ESPR (before the market open)
Medtronic plc MDT (before the market open)
Exact Sciences Corporation EXAS (after the close)
Glaukos Corporation GKOS (after the close)
Penumbra, Inc. PEN (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
Halozyme Therapeutics, Inc. HALO (after the close)
Tandem Diabetes Care, Inc. TNDM (after the close)

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

Wednesday

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

Thursday

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

Friday

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

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