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.

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 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.

See Also: What's Behind TrovaGene's Volatile Ride?

Earnings

Monday

  • Athenex Inc ATNX (before the market open)
  • Dicerna Pharmaceuticals Inc DRNA (after the market close)
  • Oxford Immunotec Global PLC OXFD (after the market close)
  • Kala Pharmaceuticals Inc KALA (after the market close)
  • Zafgen Inc ZFGN (after the market close)

Tuesday

  • Corbus Pharmaceuticals Holdings Inc CRBP (before the market open)
  • Aratana Therapeutics Inc PETX (after the market close)
  • Clearside Biomedical Inc CLSD (after the market close)
  • Verastem Inc VSTM (after the market close)
  • Inovio Pharmaceuticals Inc INO (after the market close)

Wednesday

  • Trevena Inc TRVN (before the market open)
  • Galmed Pharmaceuticals Ltd GLMD (before the market open)
  • Infinity Pharmaceuticals Inc. INFI (before the market open)
  • Miragen Therapeutics Inc MGEN (after the market close)
  • Melinta Therapeutics Inc MLNT (after the market close)

Thursday

  • Neos Therapeutics Inc NEOS (before the market open)
  • Catabasis Pharmaceuticals Inc CATB (before the market open)
  • Tetraphase Pharmaceuticals Inc TTPH (after the market close)
  • Zosano Pharma Corp ZSAN (after the market close)
  • BioDelivery Sciences International, Inc. BDSI (after the market close)

Friday

  • Diplomat Pharmacy Inc DPLO (after the market close)

IPO Quiet Period Expiry

  • Avedro Inc AVDR
  • Tcr2 Therapeutics Inc TCRR
  • Hoth Therapeutics Inc HOTH
  • Stealth BioTherapeutics Corp MITO
  • Soliton Inc SOLY
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