The Week Forward In Biotech: Sanofi, Bristol-Myers Squibb Await FDA Choices, Earnings Information Stream Tapers Off


Biotech shares had a unstable journey within the week ended Might 14, with shares transferring broadly decrease for a lot of the week earlier than coming again up strongly within the last session. Among the weak spot could also be traced again to the across-the-board weak spot in markets, as macroeconomic fears unnerved merchants.

Earnings information move and data presentations at conferences served as catalysts for the week’s strikes.

Novavax, Inc. (NASDAQ: NVAX) was one of many high-profile losers of the week after it disclosed in its quarterly report that it’ll file for emergency use authorization for its COVID-19 vaccine solely within the third quarter. The timeline suggests the vaccine is prone to be made out there solely after July.

Heron Therapeutics, Inc. (NASDAQ: HRTX) succeeded in its third attempt to take it post-operative, non-opioid ache drug previous the end line.

Listed here are the important thing catalytic occasions for the unfolding week:

Conferences

2021 RBC Capital Markets International Healthcare Convention: Might 18-20

View more earnings on IBB

Cowen 2nd Annual Digital Oncology Innovation Summit: Might 21-22

Oppenheimer Uncommon & Orphan Illness Summit: Might 21

PDUFA Dates

The FDA is scheduled to announce its verdict on Sanofi’s (NASDAQ: SNY) biologic license utility for avalglucosidase alfa, an enzyme substitute remedy. It’s being evaluated for the remedy of sufferers with Pompe illness, a uncommon degenerative muscle dysfunction that may affect a person’s potential to maneuver and breathe. The PDUFA date is mounted for Tuesday, Might 17.

The regulatory company will even determine on the BLA submitted by Bristol-Myers Squibb Firm (NYSE: BMY) for Opdivo for the remedy of sufferers with surgically eliminated esophageal or gastroesophageal junction most cancers. The FDA has till Friday, Might 20, to determine on the regulatory utility.

Associated Hyperlink: Biogen’s Retinal Disease Gene Therapy Flunks Mid-Stage Study

Earnings

Milestone Scientific Inc. (NYSE: MLSS) (Monday, earlier than the market shut)
Pieris Prescribed drugs, Inc. (NASDAQ: PIRS) (Monday, earlier than the market shut)
Titan Medical Inc. (NASDAQ: TMDI) (Monday, earlier than the market shut)
Paratek Prescribed drugs, Inc. (NASDAQ: PRTK) (Monday, earlier than the market shut)
F-star Therapeutics, Inc. (NASDAQ: FSTX) (Monday, earlier than the market shut)
Cerevel Therapeutics Holdings, Inc. (NASDAQ: CERE) (Monday, earlier than the market shut)
AcelRx Prescribed drugs, Inc. (NASDAQ: ACRX) (Monday, after the shut)
Aytu Biopharma, Inc. (NASDAQ: AYTU) (Monday, after the shut)
Adamis Prescribed drugs Company (NASDAQ: ADMP) (Monday, after the shut)
Clearside Biomedical, Inc. (NASDAQ: CLSD) (Monday, after the shut)
OncoCyte Company (NASDAQ: OCX) (Monday, after the shut)
Helius Medical Applied sciences, Inc. (NASDAQ: HSDT) (Monday, after the shut)
Onconova Therapeutics, Inc. (NASDAQ: ONTX) (Monday, after the shut)
PAVmed Inc. (NASDAQ: PAVM) (Monday, after the shut)
Rockwell Medical, Inc. (NASDAQ: RMTI) (Monday, after the shut)
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (Wednesday)

IPOs

IPO Quiet Interval Expiry

NeuroPace, Inc. (NASDAQ: NPCE)
Impel NeuroPharma, Inc. (NASDAQ: IMPL)
Rain Therapeutics Inc. (NASDAQ: RAIN)
Treace Medical Ideas, Inc. (NASDAQ: TMCI)

Associated Hyperlink: Why Bionano Genomics, CorMedix and Eloxx Are Moving Friday

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