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


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

Conferences

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  • 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


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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.

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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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


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