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Sunday, March 10, 2019

Biotech week ahead, March 11

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 2.33% announced an $800-million deal to buy Nightstar Therapeutics PLC NITE 0.32%.
Bio-Path Holdings Inc BPTH 45.96% was the biotech performer of the week, advancing more than 250 percent.
Depression drugs had contrasting effects on Johnson & Johnson JNJ 0.14% and Allergan plc AGN 1.51%, 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 1.69% and Sanofi SA SNY 0.09%‘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 0.36% and Celgene Corporation CELG 1.46% 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 0.75%‘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.

Earnings

Monday

  • Athenex Inc ATNX 1.67% (before the market open)
  • Dicerna Pharmaceuticals Inc DRNA 1.35% (after the market close)
  • Oxford Immunotec Global PLC OXFD 0.44% (after the market close)
  • Kala Pharmaceuticals Inc KALA 0.61% (after the market close)
  • Zafgen Inc ZFGN 2.93% (after the market close)

Tuesday

  • Corbus Pharmaceuticals Holdings Inc CRBP 0.51% (before the market open)
  • Aratana Therapeutics Inc PETX 1.32% (after the market close)
  • Clearside Biomedical Inc CLSD 2.99% (after the market close)
  • Verastem Inc VSTM (after the market close)
  • Inovio Pharmaceuticals Inc INO 5.92% (after the market close)

Wednesday

  • Trevena Inc TRVN 4.7% (before the market open)
  • Galmed Pharmaceuticals Ltd GLMD 1.3% (before the market open)
  • Infinity Pharmaceuticals Inc. INFI 3.23% (before the market open)
  • Miragen Therapeutics Inc MGEN 2.1% (after the market close)
  • Melinta Therapeutics Inc MLNT 1.29% (after the market close)

Thursday

  • Neos Therapeutics Inc NEOS 0.93% (before the market open)
  • Catabasis Pharmaceuticals Inc CATB 6.77% (before the market open)
  • Tetraphase Pharmaceuticals Inc TTPH 9.33% (after the market close)
  • Zosano Pharma Corp ZSAN 0.42% (after the market close)
  • BioDelivery Sciences International, Inc. BDSI (after the market close)

Friday

  • Diplomat Pharmacy Inc DPLO 1.72% (after the market close)

IPO Quiet Period Expiry

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