The Week Ahead In Biotech: Sanofi, Bristol-Myers Squibb Await FDA Decisions, Earnings News Flow Tapers Off

Biotech stocks had a volatile ride in the week ended May 14, with stocks moving broadly lower for much of the week before coming back up strongly in the final session. Some of the weakness may be traced back to the across-the-board weakness in markets, as macroeconomic fears unnerved traders.

Earnings news flow and data presentations at conferences served as catalysts for the week's moves.

Novavax, Inc. (NASDAQ:NVAX) was one of the high-profile losers of the week after it disclosed in its quarterly report that it will file for emergency use authorization for its COVID-19 vaccine only in the third quarter. The timeline suggests the vaccine is likely to be made available only after July.

Heron Therapeutics, Inc. (NASDAQ:HRTX) succeeded in its third try to take it post-operative, non-opioid pain drug past the finish line.

Here are the key catalytic events for the unfolding week:

Conferences

2021 RBC Capital Markets Global Healthcare Conference: May 18-20

Cowen 2nd Annual Virtual Oncology Innovation Summit: May 21-22

Oppenheimer Rare & Orphan Disease Summit: May 21

PDUFA Dates

The regulatory agency will also decide on the BLA submitted by Bristol-Myers Squibb Company (NYSE:BMY) for Opdivo for the treatment of patients with surgically removed esophageal or gastroesophageal junction cancer. The FDA has until Friday, May 20, to decide on the regulatory application.

Related Link: Biogen's Retinal Disease Gene Therapy Flunks Mid-Stage Study

Earnings

IPOs

IPO Quiet Period Expiry

Related Link: Why Bionano Genomics, CorMedix and Eloxx Are Moving Friday

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