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

Zinger Key Points
  • Biotech stocks defied the broader market drop in the just concluded week
  • The unfolding week's catalysts include a couple of FDA decisions and presentations at two scientific conferences

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

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

On the regulatory front, Sanofi SNY-Regeneron Pharmaceuticals, Inc. 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. PFE-BioNTech SE 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 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 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. 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 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. CBAY will present data for seladelpar in patients with primary biiliary cholangitis (Sunday)

Protagonist Therapeutics, Inc. 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. 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. RSLS (Monday, before the market open)
Biocept, Inc. BIOC (likely on Monday)
Medtronic plc MDT (Thursday, before the market open)
Taro Pharmaceutical Industries Ltd. TARO (Thursday, after the close)

IPOs

IPO Quiet Period Expiry

Tenon Medical, Inc. TNON
Belite Bio, Inc BLTE
HilleVax, Inc. HLVX

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

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