The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Arrowhead Earnings And More

Biotech stocks experienced some momentum last week amid a few clinical readouts. Karuna Therapeutics Inc KRTX, which went public in June, was among the biggest gainers of the week on a positive mid-stage readout for its schizophrenia drug.

Bristol-Myers Squibb Co BMY announced the completion of its Celgene Corporation CELG buy nearly a year after the deal was announced.

During the week, the FDA approved Alnylam Pharmaceuticals, Inc.'s ALNY RNAi therapy Givlaari for the treatment of a rare genetic disorder, acute hepatic porphyria.

The following are some key catalytic events in the unfolding week for biotech investors to keep a tab on:


  • World Congress on Congestive Heart Failure & Angina: Nov. 25-26 in Paris, France.
  • International Conference on Diabetes and Cholesterol Metabolism: Nov. 25-26 in Dubai, UAE.
  • 8th International Conference on Human Genetics and Genetic Diseases: Nov. 25-26 in Madrid, Spain.
  • 7th World Hematology & Blood Disorders Conference: Nov. 25-26 in Paris.
  • International Conference on Cell and Gene Therapy: Nov. 26-27 in Lisbon, Portugal.

PDUFA Calendar

The FDA is set to rule Saturday, Nov. 30 on Aquestive Therapeutics Inc's AQST NDA for riluzole oral film as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis.

See Also: Biotech Stock On The Radar: Nabriva And Its Novel Antibiotic Portfolio

Probable Regulatory Filings  

Bausch Health Companies Inc BHC and Eton Pharmaceuticals Inc ETON: NDA filing for EM-100 in allergic conjunctivitis before the end of November. 

Revance Therapeutics Inc RVNC: BLA filing for DaxibotulinumtoxinA for Injection, or DAXI, for the treatment of glabellar lines in November. 

Aquestive Therapeutics: Rolling NDA submission for Libervant buccal film to be completed around the end of November. Libervant is being evaluated as an oral therapy for the management of seizure clusters. 

Immunomedics, Inc. IMMU: BLA resubmission for sacituzumab govitecan in late-stage metastatic triple-negative breast cancer in patients who have received at least two prior therapies in late November/early December. 

Clinical Trial Readouts

Veru Inc VERU is due to release topline results from a Phase 2 study of zuclomiphene citrate for hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer.

Evofem Biosciences Inc EVFM is scheduled to release topline data in November from the Phase 2b study dubbed AMPREVENCE that is evaluating Amphora for the prevention of urogenital acquisition of chlamydia trachomatis and neisseria gonorrhoea in women.



Arrowhead Pharmaceuticals Inc ARWR (after the close)

IPO Quiet Period Expiry

Rapt Therapeutics Inc RAPT

Oyster Point Pharma Inc OYST

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