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.

PDUFA Dates

The FDA is set to rule on Lipocine Inc 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 AKCA-Ionis Pharmaceuticals Inc 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

Earnings

Monday, May 7

• ArQule, Inc. ARQL
• Fulgent Genetics Inc FLGT
• MacroGenics Inc MGNX
• Ultragenyx Pharmaceutical Inc RARE

Tuesday, May 8

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

Wednesday, May 9

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

Thursday, May 10

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

IPO

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.