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The Week Ahead In Biotech: PDUFA Dates, Earnings, IPOs And More

Shanthi Rexaline

The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) saw a modest uptick this week amid a slew of biotech earnings news flow and a deal announced in the space.

Here's a compilation of key biotech events and catalysts an investor can look forward to in the upcoming week.

Medical, Healthcare and Biotech Conferences

  • 14th EILAT Conference on New Antiepileptic Drugs and Devices: May 13-16, in Madrid, Spain
  • 2018 World Congress on Cell and Structural Biology: May 14-15, in Osaka, Japan
  • 2018 Bank of America Merrill Lynch Healthcare Conference: May 15-17 in Las Vegas, Nevada
  • International Investigative Dermatology 2018 Meeting: May 16-19, in Orlando, Florida
  • American Society of Gene & Cell Therapy, 2018 Annual Meeting: May 16-19 in Chicago, Illinois
  • American Urological Association's 2018 Annual Meeting: May 18-21, in San Francisco


Thursday, May 17

The FDA is set to rule on the Novartis AG (ADR) (NYSE: NVS)- Amgen, Inc. (NASDAQ: AMGN) combine's BLA for their migraine treatment Aimovig.

Clinical Trial Outcomes

Xenon Pharmaceuticals Inc (NASDAQ: XENE) is scheduled to present Phase 1 interim data for its epilepsy treatment XEN1101 at the EILAT conference on Tuesday, May 15.

Voyager Therapeutics Inc (NASDAQ: VYGR) will release final Phase 1b data for its advanced Parkinson's disease treatment VY-AADC01 at the ASGCT on Wednesday, May 16.

Audentes Therapeutics Inc (NASDAQ: BOLD) is due to release final Phase 1/2 data for its X-linked Myotubular myopathy treatment AT132 at the ASGCT meeting on Wednesday. The company will also present preliminary Phase 1/2 data on AT342 to treat Crigler-Najjar syndrome treatment at the ASGCT meeting on Thursday, May 17. The syndrome is an inherited disorder that impairs bilirubin metabolism, leading to accumulation of it in blood. Bilirubin is formed when red blood cells are broken down.

View more earnings on IBB

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RXi Pharmaceuticals Corp (NASDAQ: RXII) is set to present Phase 2 data for its dermal scarring treatment RXI-109-1501 on Thursday. RXi will also present Phase 2 data on its cutaneous wart treatment Samcyprone on Friday, May 18.

GTx, Inc. (NASDAQ: GTXI) is scheduled to present updated open-label data from the Phase 2 trial of its stress urinary incontinence therapy enobosarm at the AUA on Friday.

Rocket Pharmaceuticals Inc (NASDAQ: RCKT) will release updated Phase 1/2 data for its Fanconi anemia treatment at the ASGCT meeting in the form of a poster on Friday.

CELYAD SA/ADR (NASDAQ: CYAD) is set to release updated data on CYAD-01, its pipeline candidate for various solid and hematologic cancers, at the ASGCT meeting on Saturday, May 19.

ProQR Therapeutics NV (NASDAQ: PRQR) is scheduled to release Phase 1/2 data on its epidermolysis bullosa treatment candidate QR-313 at the IID meeting on Saturday.


Monday, May 14

  • Bovie Medical Corporation (NYSE: BVX)
  • Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI)
  • Orthopediatrics Corp (NASDAQ: KIDS)

Tuesday, May 15

  • Ampliphi Biosciences Corp (NYSE: APHB)
  • Onconova Therapeutics Inc (NASDAQ: ONTX)

Thursday, May 17

  • Vascular Biogenics Ltd (NASDAQ: VBLT)

Friday, May 18

  • AstraZeneca plc (ADR) (NYSE: AZN)

IPO Quiet Period Expirations

  • Surface Oncology Inc (NASDAQ: SURF)

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