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

Shanthi Rexaline

Biotech stocks saw a reversal in sentiment as the week saw an earnings deluge from small-, micro- and nano-cap biotechs and some M&A activity.

Here are some key catalysts for the unfolding week that should be on the radar of a biotech investor.

Conferences

  • Bank of America Merrill Lynch 2019 Healthcare Conference – May 13-15, in Las Vegas
  • Oppenheimer 4th Annual Emerging Growth Conference – May 14, in New York
  • Oppenheimer Oncology Insight Summit – May 16, in New York
  • National Lipid Association 2019 Scientific Sessions – May 16-19, in Miami
  • 8th Annual Summit on Microbiology - May 17-18, in Philadelphia

PDUFA Dates

The FDA is set to rule Monday on Regeneron Pharmaceuticals Inc (NASDAQ: REGN)'s sBLA for Eylea in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema.

Clinical Trial Readouts

Sesen Bio Inc (NASDAQ: SESN) is scheduled to release updated preliminary Phase 3 data for Vicinium in non-muscle invasive bladder cancer on Monday.

View more earnings on IBB

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) will release interim Phase 2 data for ACH-447 in paroxysmal nocturnal hemoglobinuria on Friday.

The Medicines Company (NASDAQ: MDCO) will release Phase 2 data for inclisiran from a study called ORION 3 that is evaluating the pipeline asset for cardiovascular disease. The presentation is scheduled to be made at the National Lipid Association Scientific Sessions on Saturday, May 18.

Abstracts For Presentations at the American Society of Clinical Oncology Meeting

Amgen, Inc. (NASDAQ: AMGN) – Phase 1 data for AMG 510 in solid tumors

Adcom Schedule

The Oncologic Drugs Advisory Committee will discuss DAIICHI SANKYO/S ADR (OTC: DSNKY)'s NDA for pexidartinib capsule for treating adult patients with giant cell tumor of the tendon sheath. The committee will also vote on the Japanese company's NDA for quizartinib tablets being tested in adults with relapsed or refractory acute myeloid leukemia which is FLT3-ITD positive.

Both meetings are scheduled for Tuesday.

Earnings

Monday

  • Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) (before the market open)
  • Capricor Therapeutics Inc (NASDAQ: CAPR) (after the close)

Tuesday

  • Matinas BioPharma Holdings Inc (NYSE: MTNB) (before the market open)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (before the market open)
  • Dare Bioscience Inc (NASDAQ: DARE) (after the close)
  • Cesca Therapeutics Inc (NASDAQ: KOOL) (after the close)
  • Zosano Pharma Corp (NASDAQ: ZSAN) (after the close)

Wednesday

  • Vascular Biogenics Ltd (NASDAQ: VBLT) (before the market open)
  • Rubius Therapeutics Inc (NASDAQ: RUBY) (before the market open)
  • Edap Tms SA (NASDAQ: EDAP) (after the close)
  • Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (after the close)
  • Altimmune Inc (NASDAQ: ALT)

IPO Quiet Period Expirations

Brainsway (NASDAQ: BWAY)
Turning Point Therapeutics Inc (NASDAQ: TPTX)
Hookipa Pharma Inc (NASDAQ: HOOK)

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