The Week Ahead In Biotech: ESMO Conference, PDUFA Dates, Clinical Trial Results And IPOs

Shanthi Rexaline

Here are a few catalysts that can dictate the directional moves of biotech stocks in the upcoming week:

Conferences

  • European Society For Medical Oncology, or ESMO, 2018 Congress – Oct. 19-23, in Munich, Germany

  • 11th Annual Conference on Stem Cell and Regenerative Medicine – Oct. 15-16, in Helsinki, Finland

  • International Conference on Obesity and Chronic Diseases – Oct. 15-16, in Dubai, UAE

  • 22nd European Nephrology Conference – Oct. 15-16, in Warsaw, Poland

  • International Conference on Diabetes and Cholesterol Metabolism – Oct. 15-17, in Dubai

  • 9th European Congress on Rheumatology, Autoimmunity and Orthopedics -Oct. 16-17, in Warsaw, Poland

  • The American Society of Human Genetics, or ASHG, 2018 Meeting – Oct. 16-20, in San Diego, California

  • Annual Congress on Cellular Therapies, Cancer, Stem Cells and Bio Medical Engineering – Oct. 17-18, in New York

  • 3rd International Conference on Embryology and Human Genetics – Oct. 17-18, in Las Vegas

  • 4th International Conference on Synthetic Biology and Tissue Engineering – Oct. 18-19, in Rome, Italy

  • 27th International Conference on Neurology and Cognitive Neuroscience – Oct. 18-19, in Warsaw, Poland

  • Euro Oncology Summit – Oct. 18-19, in Amsterdam, Netherlands

  • 14th Global Biomarkers Summit – Oct. 18-19, in Amsterdam

  • 10th World Congress and Expo on Immunity, Autoimmunity Inflammation and Immunotherapies – Oct. 19-20, in New York

  • 3rd Annual Kidney Congress – Oct. 19-20, in New York, U.S.

  • 16th International Conference on Nephrology & Therapeutics – Oct. 19-20, in New York

  • 5th International Conference on Parkinson's disease and Movement Disorders – Oct. 19-20, in New York

  • 2018 American College of Rheumatology, or ACR, Annual Meeting – Oct. 19 - 24 in Chicago, Illinois

PDUFA Dates

The FDA is set to rule on Regeneron Pharmaceuticals Inc (NASDAQ: REGN)- Sanofi SA (NYSE: SNY)'s sBLA for Dupixent, which is being evaluated for adults and adolescents aged 12 years or older with moderate-to-severe asthma. Dupixent is a monoclonal antibody approved already for the treatment of adults with moderate-to-severe atopic dermatitis that is not properly controlled with topical therapies.

The PDUFA date is set for Saturday, Oct. 20.

Clinical Trial Results

  • ArQule, Inc. (NASDAQ: ARQL) is set to present Phase 1/2 data for ARQ 092, its treatment candidate for overgrowth diseases, at ASHG 2018 Oct. 17.

  • Selecta Biosciences Inc (NASDAQ: SELB) will present Phase 2 five-monthly data on its tophaceous gout candidate SEL-212 at the ACR meeting to be held between Oct. 19 and Oct. 24.

  • Novartis AG (NYSE: NVS) is due to present Phase 3 data for Cosentyx for treating psoriatic arthritis at the ACR meeting.

See Also: Akorn's Generic Drug For Inadequate Eye Lashes Receives FDA Nod

ESMO Presentations

  • Epizyme Inc (NASDAQ: EPZM) – Phase 2 data for Tazemetostat (epithelioid Sarcoma)

  • Merus NV (NASDAQ: MRUS) – Phase 1/2 data for MCLA-128 (gastric cancer, ovarian, endometrial and non-small cell lung cancer)

  • Aeglea Bio Therapeutics Inc (NASDAQ: AGLE) – Phase 1 data for Pegzilarginase (solid tumors)

  • Immune Design Corp (NASDAQ: IMDZ) – Phase 2 data for CMB305 (soft tissue sarcoma)

  • Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) – Phase 1 data for DCC-2618(gastrointestinal stromal cancers)

  • Kura Oncology Inc (NASDAQ: KURA) – Phase 3 data for Tipifarnib (head and neck squamous cell carcinomas )

  • TESARO Inc (NASDAQ: TSRO) – Phase 1 data for TSR-042 (solid tumors), Phase 3 data for Niraparib (first-line ovarian cancer) & Phase 2 data for Niraparib + bevacizumab (ovarian cancer)

  • Loxo Oncology Inc (NASDAQ: LOXO) – duration of response data for Larotrectinib (solid tumor that harbor a TRK fusion)

  • Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) – Phase 3 data for Tecentriq plus nab-paclitaxe (first-line triple-negative breast cancer)

  • Seattle Genetics, Inc. (NASDAQ: SGEN) – Phase 1/2 data for Tisotumab Vedotin (recurrent cervical cancer)

  • Agenus Inc (NASDAQ: AGEN) – Phase 1/2 data for AGEN2034 and AGEN1884 (solid tumors) & Phase 1/2 data for AGEN2034 (cervical cancer)

  • Oncomed Pharmaceuticals Inc (NASDAQ: OMED) – Phase 1b data (Navicixizumab)

  • G1 Therapeutics Inc (NASDAQ: GTHX) – Updated Phase 2a data for Trilaciclib (second/third-line small-cell lung cancer)

  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) – Phase 1 initial safety data for MAGE-A10 (non-Small Cell Lung Cancer)

  • Dynavax Technologies Corporation (NASDAQ: DVAX) – updated Phase 1/2 data for SD-101 + Keytruda (melanoma & head and neck squamous cell carcinoma)

  • BIOLINERX Ltd/S ADR (NASDAQ: BLRX) – Phase 2 top-line data for BL-8040 in combination with Keytruda (pancreatic cancer)

  • ImmunoGen, Inc. (NASDAQ: IMGN) – updated Phase 1b/2 data for Mirvetuximab soravtansine (ovarian and relapsed endometrial cancer)

Pending Q3 Releases

Acorda Therapeutics Inc (NASDAQ: ACOR) is due to release Phase 2 data for its primary sclerosing cholangitis treatment option BTT1023

GALAPAGOS NV/S ADR (NASDAQ: GLPG) is due to release Phase 2 data for its combo treatment GLPG 2451+2222+2737 for cystic fibrosis in homozygous F508del patients.

View more earnings on IBB

Novo Nordisk A/S (ADR) (NYSE: NVO) will release Phase 2 data for its Concizumab that is being evaluated as a treatment option for hemophilia A.

Earnings

Wednesday, Oct. 17

  • Abbott Laboratories (NYSE: ABT) (before the market open)

Thursday, Oct. 18

  • Intuitive Surgical, Inc. (NASDAQ: ISRG)(after the market close)

IPOs

LogicBio Therapeutics, a pre-clinical gene editing company developing therapies for rare diseases, is set to offer 5.77 million, priced in a $12-$14 range. The company seeks to list its shares on the Nasdaq under the ticker symbol LOGC.

PhaseBio Pharmaceuticals will offer 5 million in an IPO, priced between $12 and $14. The biotech that develops therapies for orphan diseases is to list its shares on the Nasdaq under the ticker symbol PHAS.

Medical device company SI-BONE is to offer 6 million shares in an IPO, with an estimated price range of $13-$15. The shares will be listed on the Nasdaq under the ticker symbol SIBN.

IPO Quiet Period Expiry

Elanco Animal Health Inc (NYSE: ELAN)

Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)

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