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

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 REGN- Sanofi SA 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. 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 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 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 EPZM – Phase 2 data for Tazemetostat (epithelioid Sarcoma)
• Merus NV MRUS – Phase 1/2 data for MCLA-128 (gastric cancer, ovarian, endometrial and non-small cell lung cancer)
• Aeglea Bio Therapeutics Inc AGLE – Phase 1 data for Pegzilarginase (solid tumors)
• Immune Design Corp IMDZ – Phase 2 data for CMB305 (soft tissue sarcoma)
• Deciphera Pharmaceuticals Inc DCPH – Phase 1 data for DCC-2618(gastrointestinal stromal cancers)
• Kura Oncology Inc KURA – Phase 3 data for Tipifarnib (head and neck squamous cell carcinomas )
• TESARO Inc 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 LOXO – duration of response data for Larotrectinib (solid tumor that harbor a TRK fusion)
• Roche Holdings AG Basel ADR Common Stock RHHBY – Phase 3 data for Tecentriq plus nab-paclitaxe (first-line triple-negative breast cancer)
• Seattle Genetics, Inc. SGEN – Phase 1/2 data for Tisotumab Vedotin (recurrent cervical cancer)
• Agenus Inc AGEN – Phase 1/2 data for AGEN2034 and AGEN1884 (solid tumors) & Phase 1/2 data for AGEN2034 (cervical cancer)
• Oncomed Pharmaceuticals Inc OMED – Phase 1b data (Navicixizumab)
• G1 Therapeutics Inc GTHX – Updated Phase 2a data for Trilaciclib (second/third-line small-cell lung cancer)
• Adaptimmune Therapeutics PLC – ADR ADAP – Phase 1 initial safety data for MAGE-A10 (non-Small Cell Lung Cancer)
• Dynavax Technologies Corporation DVAX – updated Phase 1/2 data for SD-101 + Keytruda (melanoma & head and neck squamous cell carcinoma)
• BIOLINERX Ltd/S ADR BLRX – Phase 2 top-line data for BL-8040 in combination with Keytruda (pancreatic cancer)
• ImmunoGen, Inc. IMGN – updated Phase 1b/2 data for Mirvetuximab soravtansine (ovarian and relapsed endometrial cancer)

Pending Q3 Releases

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

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

Novo Nordisk A/S (ADR) 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 ABT (before the market open)

Thursday, Oct. 18

• Intuitive Surgical, Inc. 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 ELAN

Y-mAbs Therapeutics, Inc YMAB