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Sunday, May 22, 2022

Biotech week ahead, May 23

 Biotech stocks advanced in the week ending May 22, defying the broader market retreat. The defensive nature of the industry and stock-specific moves lent support.

The spread of the monkey pox virus in the U.S. and Europe sparked a rally in companies working on vaccine candidates against viruses. GeoVax Labs, Inc. 

 was the biggest beneficiary, with its stock more than doubling in the week.

NanoViricides, Inc. 

 also advanced strongly following positive clinical updates provided by the company.

On the regulatory front, Sanofi -Regeneron Pharmaceuticals, Inc.  received the Food and Drug Administration's approval for expanding Dupixent's label to include eosinophilic esophagitis as an indication.

A booster shot of Comirnaty, the COVID vaccine co-developed by Pfizer, Inc. 

-BioNTech SE , was authorized by the FDA for use in children in the age group of 5-11 years.

Here are the key catalysts for the unfolding week:

Conferences

Digestive Disease Week, or DDW, 2022: May 21-24, San Diego, California and virtually
European Society of Cardiology, or ESC, World Congress On Acute Heart Failure: May 21-24, in Madrid, Spain & virtually
BioEquity Europe 2022: May 23-24, 2022 (virtual one-on-one meetings)
The UBS Global Healthcare Conference: May 23-25, in New York
H.C. Wainwright Global Investment Conference 2022: May 23-26, in Miami Beach, Florida & virtually

PDUFA Dates

The FDA is scheduled to rule on Verrica Pharmaceuticals Inc.'s 

 new drug application for VP-102 as a potential treatment option for molluscum contagiosum and common warts. The PDUFA goal date is set for Tuesday, May 24.

Bristol-Myers Squibb Company's 

 has a decision date of Saturday, May 28, for Opdivo-Yervoy combination as a first-line treatment option for adults with advanced, metastatic esophageal squamous cell carcinoma.

Clinical Readout/Presentations

Windtree Therapeutics, Inc. 

 will present data at the ESC Heart Failure Congress, on the istaroxime Phase 2 study in early cardiogenic shock patients. (Monday)

At the same congress, Cytokinetics, Incorporated 

 is due to present interim data from the open-label extension study of aficamten in hypertrophic cardiomyopathy patients. (Monday)

At the DDW meeting, CymaBay Therapeutics, Inc. 

 will present data for seladelpar in patients with primary biiliary cholangitis (Sunday)

Protagonist Therapeutics, Inc. 

 is scheduled to present at the DDW meeting topline data from the Phase 2 study of PN-943 in ulcerative colitis. (Tuesday)

AbbVie Inc. 

 will present at the DDW meeting Phase 3 data for upadacitinib induction therapy in patients with moderately to severely active Crohn's disease who failed prior biologics. (Tuesday)

Earnings

ReShape Lifesciences Inc. 

 (Monday, before the market open)
Biocept, Inc.  (likely on Monday)
Medtronic plc  (Thursday, before the market open)
Taro Pharmaceutical Industries Ltd.  (Thursday, after the close)

IPOs

IPO Quiet Period Expiry

Tenon Medical, Inc. 


Belite Bio, Inc 
HilleVax, Inc. 

https://www.benzinga.com/general/biotech/22/05/27340007/the-week-ahead-in-biotech-may-22-28-verrica-bristol-myers-squibb-fda-decisions-medtronic-earnings

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