Last week was an event-filled one for the biotech space, with M&A, FDA decisions, clinical trial results and earnings all on offer.
Depression drugs had contrasting effects on Johnson & Johnson (NYSE: JNJ) and Allergan plc (NYSE: AGN), with the former's novel treatment-resistant depression drug passing FDA muster — although with a boxed warning — while the latter's major depressive disorder drug flunked a late-stage trial.
The following are key biotech catalysts that could sway stocks in the unfolding week.
- 13th Annual Conference on Stem Cell & Regenerative Medicine - March 11-12 in Nice, France
- Cowen & Co. 39th Healthcare Conference – March 11-13 in Boston, Massachusetts
- 13th Annual Canaccord Genuity Musculoskeletal Conference - March 12 in Las Vegas
- Barclays Global Healthcare Conference 2019 – March 12-14 in Miami Beach
- 20th World Dermatology Congress - March 13-14 in Singapore City, Singapore
- 12th World Congress on Virology and Infectious Diseases - March 13-14 in Singapore City
- BioCapital Europe 2019, organized by Life Sciences Partners – March 14 in Amsterdam, The Netherlands
- Annual Congress on Neurology & Neuroscience - March 14-15 in Paris, France
- European Autism Congress - March 14-15 in Zagreb, Croatia
- 4th Global Summit on Heart Diseases - March 15-16 in Singapore City
The FDA is set to rule on Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA (NASDAQ: SNY)'s sBLA for Dupixent, with the approval being sought for an expanded indication to include adolescents with moderate-to-severe atopic dermatitis. The PDUFA date is scheduled for Monday.
Roche Holdings AG Basel ADR (OTC: RHHBY) and Celgene Corporation (NASDAQ: CELG) await a FDA nod for Tecentriq plus chemotherapy Abraxane as first-line treatment of unresectable, locally advanced or metastatic triple-negative breast cancer in people whose disease expresses PD-L1 protein, as determined by PD-L1 biomarker testing. The PDUFA date is set for Tuesday.
The FDA will decide on Aerie Pharmaceuticals Inc (NASDAQ: AERI)'s NDA for Roclatan — its investigational once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. The PDUFA date is scheduled for Thursday.
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- Athenex Inc (NASDAQ: ATNX) (before the market open)
- Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) (after the market close)
- Oxford Immunotec Global PLC (NASDAQ: OXFD) (after the market close)
- Kala Pharmaceuticals Inc (NASDAQ: KALA) (after the market close)
- Zafgen Inc (NASDAQ: ZFGN) (after the market close)
- Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) (before the market open)
- Aratana Therapeutics Inc (NASDAQ: PETX) (after the market close)
- Clearside Biomedical Inc (NASDAQ: CLSD) (after the market close)
- Verastem Inc (NASDAQ: VSTM) (after the market close)
- Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the market close)
- Trevena Inc (NASDAQ: TRVN) (before the market open)
- Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
- Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (before the market open)
- Miragen Therapeutics Inc (NASDAQ: MGEN) (after the market close)
- Melinta Therapeutics Inc (NASDAQ: MLNT) (after the market close)
- Neos Therapeutics Inc (NASDAQ: NEOS) (before the market open)
- Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (before the market open)
- Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) (after the market close)
- Zosano Pharma Corp (NASDAQ: ZSAN) (after the market close)
- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (after the market close)
- Diplomat Pharmacy Inc (NYSE: DPLO) (after the market close)
IPO Quiet Period Expiry
- Avedro Inc (NASDAQ: AVDR)
- Tcr2 Therapeutics Inc (NASDAQ: TCRR)
- Hoth Therapeutics Inc (NASDAQ: HOTH)
- Stealth BioTherapeutics Corp (NASDAQ: MITO)
- Soliton Inc (NASDAQ: SOLY)
See more from Benzinga
- The Daily Biotech Pulse: Tonix Gets European Patent, EC Nod For Roche, Insys Earnings
- Daily Biotech Pulse: Allergan's Depression Drug Flunks Late-Stage Trial, Apellis Offering, ShockWave Medical IPO
- The Daily Biotech Pulse: Horizon Pharma Under DoJ Radar, FDA Greenlights J&J's Depression Drug, Endologix Reverse Split
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