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

Shanthi Rexaline

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).

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.

View more earnings on XBI

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.

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)

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