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The Week Ahead In Biotech: Earnings Trickle In, While Glaxo, Melinta, Foamix And Eton Await FDA Verdict

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The Week Ahead In Biotech: Earnings Trickle In, While Glaxo, Melinta, Foamix And Eton Await FDA Verdict

Biotech stocks saw some strength last week. Positive clinical readouts, a couple of M&A deals and hopes of drug companies clinching a broader opioid settlement agreement worked in favor of the sector.

Reata Pharmaceuticals Inc (NASDAQ: RETA) was among the strong performers of the week following a positive Phase 2 readout for its drug to treat Friedreich ataxia.

Here are the key catalysts for the upcoming week.

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Conferences

  • United European Gastroenterology Week – Oct. 19-23 in Barcelona, Spain
  • The Chest Annual Meeting – Oct. 19-23, in New Orleans, Louisiana
  • 21st World Congress on Advances in Gastroenterology and Hepatology - Oct. 21-22 in Melbourne, Australia
  • Annual Congress on Vaccine Immunology & HIV/AIDS - Oct. 21-22 in Copenhagen, Denmark
  • 12th International Conference on Allergy & Immunology – Oct. 21-22 in Rome, Italy
  • Targeted Protein Degradation Summit – Oct. 22-24, in Boston, Massachusetts
  • European Society of Gene and Cell Therapy 27th Annual Congress – Oct. 22-25 in Barcelona
  • European Heart Congress – Oct. 23-24 in Prague, Czech Republic
  • 11th International Conference on Predictive, Preventive and Personalized Medicine & Molecular Diagnostics – Oct. 23-24 in Amsterdam, Netherlands
  • 23rd European Nephrology Conference – Oct. 23-24 in Rome, Italy
  • 15th World Congress on Blood Cancer – Oct. 23-24 in Prague, Czech Republic
  • 32nd European Cardiology Conference – Oct. 24-26 in Zurich, Switzerland

PDUFA Dates

Sunday

The FDA is set to rule on Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)'s NDA for FMX101 in treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older.

Monday

The regulatory is also expected to issue its verdict on Eton Pharmaceuticals Inc (NASDAQ: ETON)'s NDA for ET-202, a ready-to-use injectable formulation of phenylephrine.

Thursday

Melinta Therapeutics Inc NASDAQ: MLNT) and Ligand Pharmaceuticals Inc. (NASDAQ: LGND) await FDA decision on a label expansion for Baxdella in community-acquired bacterial pneumonia.

The FDA is scheduled to rule on GlaxoSmithKline plc (NYSE: GSK)'s sNDA for Zejula in treating advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or homologous recombination deficiency.

See Also: Biotech Stock On The Radar: Assessing Mirati's Oncology Franchise With An Eye On Multiple Readouts

Clinical Trial Readouts

Protagonist Therapeutics Inc (NASDAQ: PTGX) will present Phase 1 data for PTG-200 in Crohn's disease on Tuesday.

Arvinas Inc (NASDAQ: ARVN) is scheduled to present at the Targeted Protein Degradation Summit initial Phase 1 data on ARV-110 for treating castration-resistant prostate cancer on Wednesday. The company will also present Phase 1 data for ARV-471 in ER+ positive/HER2-negative breast cancer at the summit.

Bellerophon Therapeutics Inc (NASDAQ: BLPH) is due to present Phase 2b additional cohort 1data at the CHEST meeting on Wednesday.

Axovant Gene Therapies Ltd (NASDAQ: AXGT) is scheduled to present Phase 1/2 data for AXO-Lenti-PD in Parkinson's disease and AXO-AAV-GM2 in GM2 gangliosidosis. Both presentations are to be made at the ESGCT annual Congress on Wednesday.

Earnings

Wednesday, Oct. 23

  • Eli Lilly And Co (NYSE: LLY) (before the market open)
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (before the market open)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close)
  • Edwards Lifesciences Corp (NYSE: EW) (after the close)

Thursday, Oct. 24

  • Baxter International Inc (NYSE: BAX) (before the market open)
  • Integra Lifesciences Holdings Corp (NASDAQ: IART) (before the market open)
  • West Pharmaceutical Services Inc. (NYSE: WST (before the market open)
  • Anika Therapeutics Inc (NASDAQ: ANIK) (after the close)
  • ResMed Inc. (NYSE: RMD) (after the close)
  • Illumina, Inc. (NASDAQ: ILMN) (after the close)
  • Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)

IPOs

Phathom Pharmaceuticals, a company working on in-licensed assets for treating gastrointestinal disorders, proposes to offer 7.9 million shares in an IPO, estimated to be priced between $18 and $20. The company seeks to list its shares on the Nasdaq under the ticker symbol "PHAT."

Posted-In: Biotech News Previews FDA IPOs Top Stories Trading Ideas Best of Benzinga

 

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