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. 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. 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 FDA is scheduled to announce its verdict on Sanofi's SNY biologic license application for avalglucosidase alfa, an enzyme replacement therapy. It is being evaluated for the treatment of patients with Pompe disease, a rare degenerative muscle disorder that can impact an individual's ability to move and breathe. The PDUFA date is fixed for Tuesday, May 17.

The regulatory agency will also decide on the BLA submitted by Bristol-Myers Squibb Company 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

Milestone Scientific Inc. MLSS (Monday, before the market close)
Pieris Pharmaceuticals, Inc. PIRS (Monday, before the market close)
Titan Medical Inc. TMDI (Monday, before the market close)
Paratek Pharmaceuticals, Inc. PRTK (Monday, before the market close)
F-star Therapeutics, Inc. FSTX (Monday, before the market close)
Cerevel Therapeutics Holdings, Inc. CERE (Monday, before the market close)
AcelRx Pharmaceuticals, Inc. ACRX (Monday, after the close)
Aytu Biopharma, Inc. AYTU (Monday, after the close)
Adamis Pharmaceuticals Corporation ADMP (Monday, after the close)
Clearside Biomedical, Inc. CLSD (Monday, after the close)
OncoCyte Corporation OCX (Monday, after the close)
Helius Medical Technologies, Inc. HSDT (Monday, after the close)
Onconova Therapeutics, Inc. ONTX (Monday, after the close)
PAVmed Inc. PAVM (Monday, after the close)
Rockwell Medical, Inc. RMTI (Monday, after the close)
Taro Pharmaceutical Industries Ltd. TARO (Wednesday)

IPOs

IPO Quiet Period Expiry

NeuroPace, Inc. NPCE
Impel NeuroPharma, Inc. IMPL
Rain Therapeutics Inc. RAIN
Treace Medical Concepts, Inc. TMCI

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