FDA Calendar

PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
IntelGenx Technologies Corp.
FDA decision on RIZAPORT VersaFilm for the treatment of acute migraines
Heron Therapeutics Inc.
HTX-011 (Resubmitted NDA)
FDA decision on HTX-011 for the management of postoperative pain
Intercept Pharmaceuticals Inc.
Obeticholic acid (NDA)
FDA decision on obeticholic acid for fibrosis due to nonalcoholic steatohepatitis
Zogenix, Inc.
FDA decision on FINTEPLA for the treatment of seizures associated with Dravet syndrome
Celgene Corporation
Ozanimod (NDA)
FDA decision on Ozanimod for Treatment of Relapsing Forms of Multiple Sclerosis
Vertex Pharmaceuticals Inc.
VX-445 (elexacaftor), tezacaftor and ivacaftor triple therapy (NDA)
FDA decision on triple therapy to treat cystic fibrosis
FDA approved the triple therapy, under brand name Trikafta, on October 21, 2019.
Eton Pharmaceuticals, Inc
ET-105 oral liquid (NDA)
FDA decision on ET-105 oral liquid for the treatment of various forms of epilepsy
Astellas Pharma Inc.
Enfortumab vedotin (BLA)
FDA decision on Enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
Seattle Genetics Inc.
Enfortumab vedotin (BLA)
FDA decision on Enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
Merck & Co Inc.
V920 (BLA)
FDA decision on Ebola vaccine V920
NewLink Genetics
V920 (BLA)
FDA decision on Ebola vaccine V920
Horizon Pharma Inc
Teprotumumab (BLA)
FDA decision on Teprotumumab for the treatment of active thyroid eye disease
Zanubrutinib (NDA)
FDA decision on Zanubrutinib for the treatment of patients with mantle cell lymphoma
FDA approved Zanubrutinib, under brand name BRUKINSA, for the treatment of patients with mantle cell lymphoma on Nov.14, 2019
Esperion Therapeutics
Bempedoic Acid / Ezetimibe Combination Tablet (NDA)
FDA decision on bempedoic acid / ezetimibe combination tablet for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C)
Global Blood Therapeutics
Voxelotor (NDA)
FDA decision on Voxelotor for the treatment of sickle cell disease
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