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

Shanthi Rexaline
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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.

Conferences

  • 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

PDUFA Dates

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).

View more earnings on IBB

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

Earnings

Monday

  • 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)

Tuesday

  • 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)

Wednesday

  • 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)

Thursday

  • 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)

Friday

  • 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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