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The Week Ahead In Biotech: PDUFA Dates, Clinical Trials, Merck And Pfizer Earnings On Tap

The Week Ahead In Biotech: PDUFA Dates, Clinical Trials, Merck And Pfizer Earnings On Tap

After a lackluster show mid-way through the week despite M&A news and earnings, the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) staged a recovery in the later part of the week.

As the sector struggles to make a headway, here's a list of key catalytic events for the upcoming week.

Medical/Healthcare/Biotech Conferences

  • Association for Research in Vision and Ophthalmology Annual Meeting – April 29-May 3 in Honolulu, Hawaii
  • William Blair 2nd Annual Late Stage Therapeutics Conference – May 3 in New York


Monday, April 30

Amgen, Inc. (NASDAQ: AMGN) is scheduled to hear from the FDA its verdict on the company's sNDA for Kyprolis in patients with relapsed multiple myeloma. The company's sNDA seeks to include in the label overall survival results from the ENDEAVOR trial that demonstrated Kyprolis and dexamethasone reduced the risk of death by 21 percent and increased overall survival by 7.6 months compared to Velcade and dexamethasone.

Friday, May 4

The verdict on Portola Pharmaceuticals Inc (NASDAQ: PTLA)'s Andexanet alfa, a factor Xa inhibitor reversal agent, is scheduled to be announced. The FDA had issued a CRL for the pipeline candidate in August 2016.

Adcom Schedule

FDA's Antimicrobial Drugs Advisory Committee is scheduled to discuss SIGA Technologies, Inc. (NASDAQ: SIGA)‘s NDA for tecovitimat to treat smallpox caused by variola virus in adults and pediatric patients on Tuesday, May 1. The PDUFA date is set for Aug. 8, 2018.

The ADAC will also deliberate on Achaogen Inc (NASDAQ: AKAO)'s plazomicin for complicated urinary tract infections and blood stream infections in adults. The Adcom meeting is scheduled for Wednesday, May 2.

Clinical Trial Outcomes

BioTime, Inc. (NYSE: BTX) will present data from the first three cohorts of the Phase 1/2 trial for OpRegen in patients with dry age-related macular degeneration at the ARVO meeting on April 29.

Karyopharm Therapeutics Inc (NASDAQ: KPTI) is due to present Phase 2b expansion data from a study dubbed STORM, which tested its Selinexor for quadruple refractory multiple myeloma.

See Also: Syros Takes The Road Less Traveled In Gene Control, Awaits Windfall From Diverse Indications


Monday, April 30

  • Allergan plc (NYSE: AGN)
  • AxoGen, Inc Common Stock (NASDAQ: AXGN)

Tuesday, May 1

  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
  • Gilead Sciences, Inc. (NASDAQ: GILD)
  • Merck & Co., Inc. (NYSE: MRK)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Pfizer Inc. (NYSE: PFE)

Wednesday, May 2

  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Flex Pharma Inc (NASDAQ: FLKS)
  • Insmed Incorporated (NASDAQ: INSM)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Anika Therapeutics Inc (NASDAQ: ANIK)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Pacific Biosciences of California (NASDAQ: PACB)

Thursday, May 3

  • AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
  • Sarepta Therapeutics Inc (NASDAQ: SRPT)

Friday, May 4

  • Agios Pharmaceuticals, Inc. (NASDAQ: AGIO)
  • Celgene Corporation (NASDAQ: CELG)
  • ImmunoGen, Inc. (NASDAQ: IMGN)
  • Aratana Therapeutics Inc (NASDAQ: PETX)

See Also: Baird: Biogen A Buy On M&A Prospects, Underappreciated Franchises


Clinical-stage oncology-focused biotech Aslan Pharma is scheduled to price its IPO of 7.5 million shares. The shares are to be listed on the Nasdaq under the ticker symbol ASLN.

Inspire Medical Systems seeks to list its shares on the NYSE under the ticker symbol INSP, as it prepares to price its 5-million share IPO.

Unity Biotechnology, which works on therapies for age-related ailments, is set price its 5-million share IPO. The shares are to be listed on the NASDAQ under the ticker symbol UBX.


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