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The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials And Earnings

The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials And Earnings

The biotech sector notched strong gains last week, capitalizing on the positive overall market sentiment, set in motion by the trade deal between the U.S. and Mexico.

Here are a few catalysts that could drive sentiment toward the sector in the upcoming week.


  • 6th World Summit on Heart, Stroke & Neurological Disorders – Aug. 31-Sept. 1, in Boston
  • 2nd International Conference on Thyroid and Pregnancy – Sept. 3-4, in Auckland, New Zealand
  • 11th World Congress on Endocrinology and Metabolic Disorders - Sept. 3-4, in Auckland, New Zealand
  • 17th International Conference on Gastroenterology and Hepatology – Sept. 3-4, in Dubai, UAE
  • Global Experts Meeting on Infectious Diseases – Sept. 3-4, in Tokyo, Japan
  • Rodman and Renshaw 20th Annual Global Investment Conference - Sept. 4-6, at the St. Regis New York Hotel
  • B. Riley FBR Annual Healthcare Conference – Sep. 4, in New York
  • 2018 CAR-TCR Summit - Sept. 4 - 7, in Boston
  • Citi's 13th Annual Biotech Conference 2018 – Sep. 5–6 Sep., in Boston, Massachusetts
  • Baird 2018 Global Healthcare Conference – Sep. 5-6, in New York
  • 15th Asia Pacific Oncologists Annual Meeting – Sep. 5-6, in Tokyo, Japan
  • World Eye and Vision Congress - September 6-8, in Dubai, UAE
  • 18th World Gastroenterologists Summit – Sept. 7-8, in Auckland, New Zealand


Adamis Pharmaceuticals Corp (NASDAQ: ADMP) awaits the FDA decision on its sNDA for low dose Symjepi (epinephrine) injection to treat Anaphylaxis. The PDUFA date is set for Monday, Sept. 3.

The FDA is set to rule on GlaxoSmithKline plc (ADR) (NYSE: GSK)'s sBLA for Mepolizumab to treat Chronic obstructive pulmonary disease, or COPD, with an eosinophilic phenotype. The decision is due Friday, Sept. 7.

Clinical Trial Presentations

Sangamo Therapeutics Inc (NASDAQ: SGMO) is due Sept. 5 to release data from its Phase 1/2 CHAMPIONS study of its SB-913. SB-913 is being evaluated by Sangamo for mucopolysaccharidosis type II, aka Hunter syndrome, a group of debilitating inherited metabolic disorders caused by a deficiency of lysosomal enzymes needed for degradation of mucopolysaccharides.

Roche Holdings AG Basel ADR (OTC: RHHBY) is scheduled to release Sept. 5 Phase 3 data for its TECENTRIQ, chemically atezolizumab, based on a study dubbed Impower150, to treat non-squamous, non-small cell lung cancer.

bluebird bio Inc (NASDAQ: BLUE) is due to releaseupdated Phase 2/3 data on its Lenti-D to treat childhood cerebral adrenoleukodystrophy at the Society for the Study of Inborn Errors of Metabolism 2018 Symposium at 2 am EST Sep. 5.

ProQR Therapeutics NV (NASDAQ: PRQR) will release interim analysis of Phase 1/2 data for its QR-010 for treating Leber's congenital amaurosis, a form of genetic blindness, at 8:30 am GMT, Sep. 5.

Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) is set to release Sep. 5 abstract of the updated Phase 2 data on Poziotinib, its pipeline candidate for non-small cell lung cancer with exon 20 insertion mutation in EGFR, or HER2. The data is to be presented at the World Conference on Lung Cancer on Sep. 24.

See Also: Affimed Shares Soar On $5B Collaboration With Roche's Genentech

Q3 Release Schedule

Atossa Genetics Inc (NASDAQ: ATOS) is due to release preliminary Phase 1 data for Endoxifen, its male breast cancer and Gynecomastia treatment.

GALAPAGOS NV/S ADR (NASDAQ: GLPG) and Gilead Sciences, Inc. (NASDAQ: GILD) are set to release Phase 3 data for its rheumatoid arthritis candidate filgotinib, which is being evaluated in the FINCH 2 study. The companies are also due to release Phase 2 data for the same pipeline candidate for another indication, namely ankylosing spondylitis.

Omeros Corporation (NASDAQ: OMER) is scheduled to release Phase 2 data for its OMS721 for treating IgA nephropathy.

ZEALAND PHARMA/S ADR (NASDAQ: ZEAL) is due to release Phase 3 data for its dasiglucagon to treat severe hypoglycemia in diabetes.

Galectin Therapeutics Inc. (NASDAQ: GALT) is due to release Phase 1 data for its melanoma treatment combination GR-MD-02 and Merck & Co., Inc.'s (NYSE: MRK) Keytruda.

Eyegate Pharmaceuticals Inc (NASDAQ: EYEG) is due to release Phase 3 data for its EGP-437 to treat non-infectious anterior uveitis.

Palatin Technologies, Inc. (NYSE: PTN) is scheduled to release Phase 1 data for its inflammatory bowel disease candidate PL-8177.

Amarin Corporation plc (ADR) (NASDAQ: AMRN) is due to release Phase 3 data for its Vascepa to treat high triglycerides with mixed dyslipidemia.

Geron Corporation (NASDAQ: GERN) and Johnson & Johnson (NYSE: JNJ) are scheduled to release data from the Phase 2 IMbark study for their Imetelstat to treat myelofibrosis.



Misonix, Inc. (NASDAQ: MSON)

IPO Quiet Period Expiry

Vaccinex Inc (NASDAQ: VCNX)

Aridis Pharmaceuticals Inc (NASDAQ: ARDS)


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