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

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

Biotech earnings news flow accelerated in last week, with Pfizer Inc. (NYSE: PFE) and Sanofi SA (NYSE: SNY) among the noteworthy releases of the week.

With the earnings news flow set to continue, these are some of the catalysts biotech investors should watch for in the upcoming week.


  • 28th World Congress on Cardiology and Heart Diseases: Nov. 5-6 in Amsterdam, Netherlands
  • 5th International Conference on Depression, Anxiety and Stress Management: Nov. 5-6 in Bangkok, Thailand
  • 23rd Annual Congress on Pediatrics & Neonatology: Nov. 5-6 in Bangkok
  • International Conference on Bipolar Disorder: Depression and Psychiatry: Nov. 5-6 in Abu Dhabi, UAE
  • World Summit on Liver Cirrhosis and Hepatitis: Nov. 7-8 in Singapore City
  • Global Congress on Asthma, Allergy and Immunology: Nov. 7-8 in Singapore City
  • International Conference on Frontiers in Gynecologic Cancers: Nov. 7-8 in Singapore City
  • Global Congress on Asthma, Allergy and Immunology: Nov. 7-8 in Singapore City
  • The Society for Immunotherapy of Cancer, or SITC Annual Meeting: Nov. 7-11 in Washington, D.C.
  • 24th Asia-Pacific Dermatology Conference: Nov. 8-9 in Sydney, Australia
  • American Medical Association 2018 Interim Meeting: Nov. 8-13 in National Harbor, Maryland
  • 2nd Annual Summit on Cell Therapy, Tissue Science and Regenerative Medicine: Nov. 9-10 in Atlanta
  • 2nd Annual Summit on Stem Cell Research, Cell and Gene Therapy: Nov. 9-10 in Atlanta
  • The American Association for the Study of Liver Diseases, or AASLD, 2018 Liver Meeting: Nov. 9-13 in San Francisco


Merck & Co., Inc. (NYSE: MRK), which recently announced FDA approval for its Keytruda in combination with chemotherapy drugs for metastatic squamous non-small cell lung cancer, or NSCLC, has another tryst with the FDA on Friday, Nov. 9. The regulatory body will announce its verdict on Keytruda as a monotherapy for hepatocellular carcinoma. The sBLA was submitted based on the KEYNOTE-224 study.

Clinical Trial Results

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) will release Phase 2 longer-term 42-month data on its achondroplasia treatment Vosoritide Wednesday, Nov. 7.

Novartis AG (NYSE: NVS) will present Phase 3 data for its heart failure pipeline candidate Entresto at the AHA 2018 meeting to be held between Nov. 10 and 12.

Eidos Therapeutics Inc (NASDAQ: EIDX) will release Phase 2 data for AG10, its treatment candidate for transthyretin amyloidosis, on Saturday, Nov. 10.

SITC 2018 Meeting Presentations

Iovance Biotherapeutics Inc (NASDAQ: IOVA): update on Phase 2 program for LN-144 for treating refractory metastatic melanoma (Nov. 9).

Aduro BioTech Inc (NASDAQ: ADRO): initial Phase 1b data for its ADU-S100 for treating solid tumors as well as lymphoma (Nov. 9).

TESARO Inc (NASDAQ: TSRO): Phase 1 data for its solid tumor treatment combo TSR-022 plus TSR-042 (Nov. 9) as well as Phase 1 data for another solid tumor treatment candidate, TSR-033 (Nov. 7-11).

Nektar Therapeutics (NASDAQ: NKTR): Updated Phase 1/2 data for NKTR-214 plus Bristol-Myers Squibb Co (NYSE: BMY)'s Opdiva for melanoma and renal cell carcinoma and NSCLC (Nov. 9).

Corvus Pharmaceuticals Inc (NASDAQ: CRVS): Phase 2 data for its solid tumor treatment candidate CPI-444 (Nov. 10).

Leap Therapeutics Inc (NASDAQ: LPTX): Interim Phase 1 data for its TRX518 in combination with KEYTRUDA or Opdivo for treating advanced solid tumors (Nov. 7-11).

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



  • Amicus Therapeutics, Inc. (NASDAQ: FOLD) (before the market open)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (before the market open)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR) (after the market close)
  • Alimera Sciences Inc (NASDAQ: ALIM) (after the market close)
  • Akcea Therapeutics Inc (NASDAQ: AKCA) (after the market close)
  • Neurocrine Biosciences, Inc. (NASDAQ: NBIX) (after the market close)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) (after the market close)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the market close)
  • Insys Therapeutics Inc (NASDAQ: INSY) (after the market close)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (after the market close)
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the market close)
  • Kura Oncology Inc (NASDAQ: KURA) (after the market close)
  • Mylan NV (NASDAQ: MYL) (after the market close)
  • Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) (after the market close)
  • Xencor Inc (NASDAQ: XNCR) (after the market close)
  • Evolus Inc (NASDAQ: EOLS) (after the market close)
  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) (after the market close)
  • Otonomy Inc (NASDAQ: OTIC) (after the market close)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) (after the market close)


  • ANI Pharmaceuticals Inc (NASDAQ: ANIP) (before the market open)
  • Eli Lilly And Co (NYSE: LLY) (before the market open)
  • Becton Dickinson and Co (NYSE: BDX) (before the market open)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open)
  • Chimerix Inc (NASDAQ: CMRX) (before the market open)
  • InspireMD Inc (NYSE: NSPR) (before the market open)
  • SAGE Therapeutics Inc (NASDAQ: SAGE) (before the market open)
  • Spark Therapeutics Inc (NASDAQ: ONCE) (before the market open)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN) (before the market open)
  • Mallinckrodt PLC (NYSE: MNK) (before the market open)
  • Neuronetics Inc (NASDAQ: STIM) (before the market open)
  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (before the market open)
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS) (before the market open)
  • Haemonetics Corporation (NYSE: HAE) (before the market open)
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) (before the market open)
  • Adaptimmune Therapeutics PLC (NASDAQ: ADAP) (before the market open)
  • Aquestive Therapeutics Inc (NASDAQ: AQST) (after the market close)
  • Accelerate Diagnostics Inc (NASDAQ: AXDX) (after the market close)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS) (after the market close)
  • Audentes Therapeutics Inc (NASDAQ: BOLD) (after the market close)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI) (after the market close)
  • CytomX Therapeutics Inc (NASDAQ: CTMX) (after the market close)
  • Iovance Biotherapeutics Inc (NASDAQ: IOVA) (after the market close)
  • Theravance Biopharma Inc (NASDAQ: TBPH) (after the market close)
  • Cara Therapeutics Inc (NASDAQ: CARA) (after the market close)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE) (after the market close)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the market close)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the market close)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX) (after the market close)
  • Genomic Health, Inc. (NASDAQ: GHDX) (after the market close)
  • Myriad Genetics, Inc. (NASDAQ: MYGN) (after the market close)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the market close)
  • Inspire Medical Systems Inc (NYSE: INSP) (after the market close)
  • Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (after the market close)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the market close)
  • CytomX Therapeutics Inc (NASDAQ: CTMX) (after the market close)
  • Immune Design Corp (NASDAQ: IMDZ) (after the market close)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY) (after the market close)
  • DexCom, Inc. (NASDAQ: DXCM) (after the market close)
  • Fulgent Genetics Inc (NASDAQ: FLGT) (after the market close)


  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO) (before the market open)
  • Affimed NV (NASDAQ: AFMD) (before the market open)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
  • Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
  • Protalix Biotherapeutics Inc (NYSE: PLX) (before the market open)
  • Intra-Cellular Therapies Inc (NASDAQ: ITCI) (before the market open)
  • Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open)
  • Melinta Therapeutics Inc (NASDAQ: MLNT) (before the market open)
  • Recro Pharma Inc (NASDAQ: REPH) (before the market open)
  • Charles River Laboratories Intl. Inc (NYSE: CRL) (before the market open)
  • Reata Pharmaceuticals Inc (NASDAQ: RETA) (before the market open)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) (before the market open)=
  • Horizon Pharma PLC (NASDAQ: HZNP) (before the market open)
  • Miragen Therapeutics Inc (NASDAQ: MGEN) (before the market open)
  • Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK) (before the market open)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON) (after the market close)
  • Zafgen Inc (NASDAQ: ZFGN) (after the market close)
  • MacroGenics Inc (NASDAQ: MGNX) (after the market close)
  • G1 Therapeutics Inc (NASDAQ: GTHX) (after the market close)
  • Regenxbio Inc (NASDAQ: RGNX) (after the market close)
  • Viking Therapeutics Inc (NASDAQ: VKTX) (after the market close)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) (after the market close)
  • Achieve Life Sciences Inc (NASDAQ: ACHV) (after the market close)
  • Avalara Inc (NYSE: AVLR) (after the market close)
  • Arbutus Biopharma Corp (NASDAQ: ABUS) (after the market close)
  • Aileron Therapeutics Inc (NASDAQ: ALRN) (after the market close)
  • Calithera Biosciences Inc (NASDAQ: CALA) (after the market close)
  • Kindred Biosciences Inc (NASDAQ: KIN) (after the market close)
  • Nektar Therapeutics (NASDAQ: NKTR) (after the market close)
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the market close)
  • Immunomedics, Inc. (NASDAQ: IMMU)
  • Glaukos Corp (NYSE: GKOS) (after the market close)
  • Editas Medicine Inc (NASDAQ: EDIT) (after the market close)
  • Flexion Therapeutics Inc (NASDAQ: FLXN) (after the market close)
  • Ocular Therapeutix Inc (NASDAQ: OCU) (after the market close)
  • Hologic, Inc. (NASDAQ: HOLX) (after the market close)
  • Pfenex Inc (NYSE: PFNX) (after the market close)
  • Voyager Therapeutics Inc (NASDAQ: VYGR) (after the market close)
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA) (after the market close)
  • TherapeuticsMD Inc (NASDAQ: TXMD) (after the market close)


  • Karyopharm Therapeutics Inc (NASDAQ: KPTI) (before the market open)
  • Histogenics Corp (NASDAQ: HSGX) (before the market open)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (before the market open)
  • Obseva SA (NASDAQ: OBSV) (before the market open)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) (before the market open)
  • Endo International PLC (NASDAQ: ENDP) (before the market open)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX) (before the market open)
  • Misonix, Inc. (NASDAQ: MSON) (after the market close)
  • Assertio Therapeutics Inc (NASDAQ: ASRT) (after the market close)
  • BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (after the market close)
  • BioTime, Inc. (NYSE: BTX) (after the market close)
  • Coherus Biosciences Inc (NASDAQ: CHRS) (after the market close)
  • CareDx Inc (NASDAQ: CDNA) (after the market close)
  • Synthetic Biologics Inc (NYSE: SYN) (after the market close)
  • Vermillion, Inc. (NASDAQ: VRML) (after the market close)
  • ICU Medical, Incorporated (NASDAQ: ICUI) (after the market close)
  • Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the market close)
  • Transenterix Inc (NYSE: TRXC) (after the market close)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL) (after the market close)
  • DENTSPLY SIRONA Inc (NASDAQ: XRAY) (after the market close)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the market close)
  • Organovo Holdings Inc (NASDAQ: ONVO) (after the market close)


  • SurModics, Inc. (NASDAQ: SRDX) (before the market open)
  • PLx Pharma Inc (NASDAQ: PLXP) (before the market open)

IPO Quiet Period Expiry

Allogene Therapeutics, Inc. (NASDAQ: ALLO)

Equillium, Inc. (NASDAQ: EQ)

Related Link: Slow Breast Cancer Drug Sales Send Puma Biotech Shares Reeling


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