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The Week Ahead In Biotech (Sept. 16-22): Conferences, PDUFA Dates, Clinical Trial Results And IPOs

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The Week Ahead In Biotech Sept. 16-22: Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Biotech were trending mostly sideways in the week ending Sept. 14 after posting weekly gains in the previous two weeks. Notwithstanding the overall muted sentiment, there was some activity in reaction to the release of clinical trial results.

The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) remains on track to end the week modestly higher, having gained about 0.5 percent through Thursday.

The following are noteworthy catalysts for biotech investor to focus on in the unfolding week:

Conferences

  • 9th International Congress of the Growth Hormone Research and IGF Societies, or GRS & IGF: Sept. 14-17, in Seattle.
  • European Respiratory Society, or ERS, International Congress 2018: Sept. 15-19 in Paris
  • Janney Montgomery Scott Healthcare Conference 2018: Sept. 17-18 at the Union League Club in New York City
  • 24th World Cardiology Conference: Sept. 17-18 in Tin Shui Wai, Hong Kong
  • 25th Annual Cardiologists Conference : Sept. 17-18 in Hong Kong
  • 3rd International Conference on Hepatobiliary & Pancreatic Disorders: Sept. 17-18 in Philadelphia
  • 12th World Congress on Advances and Innovations in Dementia: Sept. 17-18 in Singapore City
  • 25th International Conference on Neurology: Neurochemistry, Neuropharmacology and Neurosciences: Sept. 17-18 in Dubai
  • 3rd International Conference on Tumor & Cancer Immunology and Immunotherapy: Sept. 17-18 in San Diego
  • Second annual summit on Cell Signaling and Cancer Therapy" Sept. 19 –20 in Philadelphia
  • Second annual summit on Cell Metabolism and Cytopathology: Sept. 19-20 in Philadelphia
  • Annual Summit on Pain Management - Opioid Drugs – Sep. 19-20, in San Diego, U.S.
  • 9th International Conference on Cardiac Surgery: Sept. 20-21, in Oslo
  • 6th International Conference on Hepatology: Sept. 21-22 in Osaka
  • The FDA approved Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE: TEVA)'s BLA for its migraine treatment candidate fremanezumab late Friday. 

Clinical Trial Results

  • Mylan NV (NASDAQ: MYL) and Theravance Biopharma Inc (NASDAQ: TBPH) are due to release new data on their chronic obstructive pulmonary disease treatment revefenacin at the ERS International Congress 2018 on Sunday.
  • VERONA PHARMA P/S ADR (NASDAQ: VRNA) will present expanded Phase 2b data for its COPD candidate RPL554 at the ERS International Congress 2018 at 8:30 am EST Monday, Sept. 17.

See also: Attention Biotech Investors: Mark Your Calendar For These September PDUFA Dates

Q3 Schedule

  • Omeros Corporation (NASDAQ: OMER) is scheduled to release Phase 2 data for its OMS721 for treating IgA nephropathy.
  • ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) will release Phase 3 data for its dasiglucagon to treat severe hypoglycemia in diabetes.
  • Galectin Therapeutics Inc. Common Stock (NASDAQ: GALT) is due to release Phase 1 data for its melanoma treatment combination GR-MD-02 and Merck & Co., Inc. (NYSE: MRK)'s Keytruda.
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG) is due to release Phase 2 data for its combo treatment GLPG 2451+2222+2737 for cystic fibrosis.
  • 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. The company is also set to release Phase 3 extension data for its adult growth hormone deficiency treatment candidate somapacitan.
  • Celsion Corporation (NASDAQ: CLSN) is likely to release Phase 1b data for its ovarian cancer treatment candidate GEN-1.
  • Geron Corporation (NASDAQ: GERN) and Johnson & Johnson (NYSE: JNJ) are scheduled to release primary analysis of data from the Phase 2 IMbark study for Imetelstat to treat myelofibrosis.
  • Amarin Corporation plc (ADR) (NASDAQ: AMRN) is due to release Phase 3 data for its Vascepa to treat high triglycerides with mixed dyslipidemia.
  • Inovio Pharmaceuticals Inc (NASDAQ: INO) will release Phase 1 data for its prostate cancer treatment candidate INO-5150.
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) is due to release Phase 1b data for its Type 2 diabetes treatment candidate LX2761.
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX) is set to release Phase 3 progression-free survival data for E2112, its treatment candidate for HR+ and HER2- breast cancer.
  • Cytokinetics, Inc. (NASDAQ: CYTK) will release interim analysis of Phase 1b data for its CK-2127107 for limited mobility. The company will also release results of a Phase 2 study of the same candidate for treating COPD.
  • Proteostasis Therapeutics Inc (NASDAQ: PTI) is set to release final Phase 1 data for its cystic fibrosis treatment PTI-801.
  • TapImmune Inc. (NASDAQ: TPIV) will release Phase 2 interim response data for TPIV200 that is being evaluated as second-line treatment for triple-negative breast cancer.
  • Arcus Biosciences Inc (NASDAQ: RCUS) is expected to release Phase 1 data for AB122 for treating solid tumors.
  • Ra Pharmaceuticals Inc (NASDAQ: RARX) is scheduled to release Phase 1b pharmacokinetics data for RA101495 SC, its pipeline candidate for atypical hemolytic uremic syndrome.
  • AnaptysBio Inc (NASDAQ: ANAB) is due to release Phase 2a data for its ANB020 that is being evaluated for severe adult eosinophilic asthma.
  • argenx SE – ADR (NASDAQ: ARGX) will release Phase 2 data for its immune thrombocytopenia treatment ARGX-113.
  • CTI BioPharma Corp (NASDAQ: CTIC) is due to release interim Phase 2 data for pacritinib, its pipeline candidate for myelofibrosis.

IPO

Y-MABS Therapeutics, a developer of antibody-based therapeutic cancer products, is set to offer 5.33 million shares in an IPO, with the shares expected to be priced between $14 and $16. The shares are to be listed on the Nasdaq under the ticker symbol YMAB.

Elanco Animal Health, a spin-off unit of Eli Lilly And Co (NYSE: LLY)'s global animal health medicines and vaccines business, is due to offer 62.9 million shares in an IPO, with an estimated price range per share of $20-$23. The shares will be listed on the NYSE under the ticker symbol ELAN.

Related Link: Goldman's Specialty Pharma Pair Trade: Sidelined On Endo, Bearish On Mallinckrodt

Editor's note: This story has been corrected to reflect that Arcus Biosciences — not Radius Health Inc (NASDAQ: RDUS) — is expected to release Phase 1 data for AB122 for treating solid tumors. 

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