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Last week was an event-filled one for the biotech space, with M&A, FDA decisions, clinical trial results and earnings all on offer.
Biogen Inc (NASDAQ:BIIB) announced an $800-million deal to buy Nightstar Therapeutics PLC (NASDAQ:NITE).
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Bio-Path Holdings Inc (NASDAQ:BPTH) was the biotech performer of the week, advancing more than 250 percent.
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.
Related Link: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates
The following are key biotech catalysts that could sway stocks in the unfolding week.
Conferences
- 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
PDUFA Dates
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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See Also: What's Behind TrovaGene's Volatile Ride?
Earnings
Monday
- 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)
Tuesday
- 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)
Wednesday
- 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)
Thursday
- 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)
Friday
- 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)
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.