Market Overview

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

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

After eking out a modest gain in the week ended April 27, the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) pulled back this week amid some not-so-encouraging earnings reports and negative regulatory decisions.

Will the lean trot end? Stay tuned to the upcoming week's developments on the biotech front.

Medical, Health Care And Biotech Conferences

  • 2018 Disruptive Growth and Healthcare Conference: May 8-9 in New York City.
  • Deutsche Bank 43rd Annual Health Care Conference: May 8-9 at the InterContinental Boston Hotel.


The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)'s NDA for tlando, which is tested for hypogonadism. The PDUFA action date is May 8.

Adcom Schedule

The Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet May 10 to discuss the safety and efficacy of the Akcea Therapeutics Inc (NASDAQ: AKCA)-Ionis Pharmaceuticals Inc (NASDAQ: IONS) combine's subcutaneously injected volanesoren solution for patients with familial chylomicronemia syndrome.

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates


Monday, May 7

  • ArQule, Inc. (NASDAQ: ARQL)
  • Fulgent Genetics Inc (NASDAQ: FLGT)
  • MacroGenics Inc (NASDAQ: MGNX)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)

Tuesday, May 8

  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • Opko Health Inc. (NASDAQ: OPK)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR)
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC)
  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
  • Clovis Oncology Inc (NASDAQ: CLVS)
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
  • Epizyme Inc (NASDAQ: EPZM)
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Haemonetics Corporation (NYSE: HAE)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)
  • Kindred Biosciences Inc (NASDAQ: KIN)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Loxo Oncology Inc (NASDAQ: LOXO)
  • Melinta Therapeutics, Inc. (NASDAQ: MLNT)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MAC)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • Ocular Therapeutix Inc (NASDAQ: OCUL)
  • Oncomed Pharmaceuticals Inc (NASDAQ: OMED)
  • Prothena Corporation PLC (NASDAQ: PRTA)
  • Regenxbio Inc (NASDAQ: RGNX)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Vital Therapies Inc (NASDAQ: VTL)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE)

Wednesday, May 9

  • Endocyte, Inc. (NASDAQ: ECYT)
  • FibroGen Inc (NASDAQ: FGEN)
  • Jounce Therapeutics Inc (NASDAQ: JNCE)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Mylan NV (NASDAQ: MYL)
  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Arcadia Biosciences Inc (NASDAQ: RKDA)
  • Array Biopharma Inc (NASDAQ: ARRY)
  • Audentes Therapeutics Inc (NASDAQ: BOLD)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
  • Glaukos Corp (NYSE: GKOS)
  • Horizon Pharma PLC (NASDAQ: HZNP)
  • Inovio Pharmaceuticals Inc (NASDAQ: INO)
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Viking Therapeutics Inc (NASDAQ: VKTX)

Thursday, May 10

  • Depomed Inc (NASDAQ: DEPO)
  • Karyopharm Therapeutics Inc (NASDAQ: KPTI)
  • Nektar Therapeutics (NASDAQ: NKTR)
  • Athersys, Inc. (NASDAQ: ATHX)
  • BioDelivery Sciences International, Inc (NASDAQ: BDSI)
  • BioTime, Inc. (NYSE: BTX)
  • CareDx Inc (NASDAQ: CDNA)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • Synergy Pharmaceuticals Inc (NASDAQ: SGYP)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB)
  • RXi Pharmaceuticals Corp (NASDAQ: RXII)
  • Catalyst Pharmaceuticals Inc (NASDAQ: CPRX)
  • Fibrocell Science Inc (NASDAQ: FCSC)


Immuno-oncology company Abpro is set to offer 4 million shares. The shares are to be listed on the Nasdaq under the ticker symbol ABP.

Evelo Biosciences, which focuses on therapies that act on the gut-body network, is offering 5.3 million shares. Shares are to be listed on the Nasdaq under the ticker symbol EVLO.


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