The Week Ahead In Biotech: Conferences, PDUFA Dates, Earnings, IPOs

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 BIIB announced an $800-million deal to buy Nightstar Therapeutics PLC NITE.

Bio-Path Holdings Inc BPTH was the biotech performer of the week, advancing more than 250 percent.

Depression drugs had contrasting effects on Johnson & Johnson JNJ and Allergan plc 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.

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 REGN and Sanofi SA 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 RHHBY and Celgene Corporation 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 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.