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The Week Ahead In Biotech (May 22-28): Verrica, Bristol-Myers Squibb FDA Decisions, Medtronic Earnings, Conference Presentations & More

Published 22/05/2022, 20:58
Updated 22/05/2022, 21:40
© Reuters.  The Week Ahead In Biotech (May 22-28): Verrica, Bristol-Myers Squibb FDA Decisions, Medtronic Earnings, Conference Presentations & More

© Reuters. The Week Ahead In Biotech (May 22-28): Verrica, Bristol-Myers Squibb FDA Decisions, Medtronic Earnings, Conference Presentations & More

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. (NASDAQ: GOVX) was the biggest beneficiary, with its stock more than doubling in the week.

NanoViricides, Inc. (NYSE: NNVC) also advanced strongly following positive clinical updates provided by the company.

On the regulatory front, Sanofi (EPA:SASY) (NASDAQ: SNY)-Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) 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. (NYSE: NYSE:PFE)-BioNTech SE (NASDAQ: BNTX), 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 (NASDAQ: VRCA) 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 (NYSE: NYSE:BMY) 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.

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates

Clinical Readout/Presentations Windtree Therapeutics, Inc. (NASDAQ: WINT) 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 (NASDAQ: CYTK) 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. (NASDAQ: CBAY) will present data for seladelpar in patients with primary biiliary cholangitis (Sunday)

Protagonist Therapeutics, Inc. (NASDAQ: PTGX) is scheduled to present at the DDW meeting topline data from the Phase 2 study of PN-943 in ulcerative colitis. (Tuesday)

AbbVie Inc . (NYSE: NYSE:ABBV) 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. (NASDAQ: RSLS) (Monday, before the market open)

Biocept, Inc. (NASDAQ: BIOC) (likely on Monday)

Medtronic plc (NYSE: NYSE:MDT) (Thursday, before the market open)

Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (Thursday, after the close)

IPOs IPO Quiet Period Expiry

Tenon Medical, Inc. (NASDAQ: TNON)

Belite Bio, Inc (NASDAQ: BLTE)

HilleVax, Inc. (NASDAQ: HLVX)

Related Link: White House To Prioritize Resources To Increase Production Of Baby Formula

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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