Biotech week ahead, Feb. 22

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 -0.14%

 (Get Free Alerts for AGIO) mitapivat for treating pyruvate kinase deficiency, a rare, inherited metabolic disorder.

Avenue Therapeutics, Inc. 

ATXI -10.73%

 (Get Free Alerts for 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 -0.69%

 and Sanofi 

SNY -0.7%

-Regeneron Pharmaceuticals, Inc. 

REGN -1.85%

 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 -1.68%

 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 +4.82%

 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 -1.48%

 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 -6.63%

 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 +0%

 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 -1.79%

 (before the market open)
Medtronic plc 

MDT -1.13%

 (before the market open)
Exact Sciences Corporation 

EXAS -0.86%

 (after the close)
Glaukos Corporation 

GKOS -4.33%

 (after the close)
Penumbra, Inc. 

PEN -2.34%

 (after the close)
PTC Therapeutics, Inc. 

PTCT -0.15%

 (after the close)
Halozyme Therapeutics, Inc. 

HALO -0.91%

 (after the close)
Tandem Diabetes Care, Inc. 

TNDM -3.7%

 (after the close)

Wednesday

Avanos Medical, Inc. 

AVNS -2.43%

 (before the market open)
Bausch Health Companies Inc. 

BHC -3.08%

 (before the market open)
NeoGenomics, Inc. 

NEO -4.08%

 (before the market open)
Arena Pharmaceuticals, Inc. 

ARNA -0.19%

 (after the market close)
Fulgent Genetics, Inc. 

FLGT +1.28%

 (after the market close)
Global Blood Therapeutics, Inc. 

GBT -1.45%

 (after the market close)
BioMarin Pharmaceutical Inc. 

BMRN -6.02%

 (after the market close)
Guardant Health, Inc. 

GH -4.15%

 (after the market close)
Inari Medical, Inc. 

NARI -2.52%

 (after the market close)
Insulet Corporation 

PODD -2.75%

 (after the market close)
iRhythm Technologies, Inc. 

IRTC -4.58%

 (after the market close)
Maravai LifeSciences Holdings, Inc. 

MRVI +2.54%

 (after the market close)
NuVasive, Inc. 

NUVA -0.53%

 (after the market close)
Nevro Corp. 

NVRO -1.74%

 (after the market close)

Thursday

Agios (before the market open)
Editas Medicine, Inc. 

EDIT -2.63%

 (before the market open)
Moderna, Inc. 

MRNA -0.42%

 (before the market open)
Pacira BioSciences, Inc. 

PCRX -0.17%

 (before the market open)
Sage Therapeutics, Inc. 

SAGE +1.82%

 (before the market open)
Vericel Corporation 

VCEL -0.8%

 (before the market open)
AbCellera Biologics Inc. 

ABCL -1.51%

 (after the market close)
CareDx, Inc 

CDNA -2%

 (after the market close)
Axonics, Inc. 

AXNX -3.13%

 (after the market close)
Collegium Pharmaceutical, Inc. 

COLL -1.09%

 (after the market close)
Emergent BioSolutions Inc. 

EBS -1.47%

 (after the market close)
Codexis, Inc. 

CDXS -3.36%

 (after the market close)
ICU Medical, Inc. . 

ICUI -0.3%

 (after the market close)
Invitae Corporation 

NVTA -3.76%

 (after the market close)
Iovance Biotherapeutics, Inc. 

IOVA -2.08%

 (after the market close)
Merit Medical Systems, Inc. 

MMSI -3.15%

 (after the market close)
LeMaitre Vascular, Inc. 

LMAT -0.28%

 (after the market close)
MacroGenics, Inc. 

MGNX -3.34%

 (after the market close)
Natera, Inc. 

NTRA -2.75%

 (after the market close)
OPKO Health, Inc. 

OPK +0.32%

 (after the market close)
Sangamo Therapeutics, Inc. 

SGMO -0.53%

 (after the market close)
Silk Road Medical, Inc 

SILK -4.09%

 (after the market close)
Travere Therapeutics, Inc. 

TVTX -0.32%

 (after the market close)
Y-mAbs Therapeutics, Inc. 

YMAB -2.02%

Vir Biotechnology, Inc. 

VIR -2.65%

 (after the market close)

Friday

Biohaven Pharmaceutical Holding Company Ltd. 

BHVN -0.94%

 (before the market open)
ImmunoGen, Inc. 

IMGN -5.06%

 (before the market open)

https://www.benzinga.com/general/biotech/22/02/25732174/the-week-ahead-in-biotech-feb-20-26-reata-awaits-fda-decision-bausch-health-moderna-lead-earnings