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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
Ticker
Drug
Event
Date
Outcome
Details
IntelGenx Technologies Corp.
RIZAPORT VersaFilm (NDA)
FDA decision on RIZAPORT VersaFilm for the treatment of acute migraines
03/26/2020
Heron Therapeutics Inc.
HTX-011 (Resubmitted NDA)
FDA decision on HTX-011 for the management of postoperative pain
03/26/2020
Intercept Pharmaceuticals Inc.
Obeticholic acid (NDA)
FDA decision on obeticholic acid for fibrosis due to nonalcoholic steatohepatitis
03/26/2020
Zogenix, Inc.
FINTEPLA (NDA)
FDA decision on FINTEPLA for the treatment of seizures associated with Dravet syndrome
03/25/2020
Celgene Corporation
Ozanimod (NDA)
FDA decision on Ozanimod for Treatment of Relapsing Forms of Multiple Sclerosis
03/25/2020
Vertex Pharmaceuticals Inc.
VX-445 (elexacaftor), tezacaftor and ivacaftor triple therapy (NDA)
FDA decision on triple therapy to treat cystic fibrosis
03/19/2020
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
03/17/2020
Astellas Pharma Inc.
Enfortumab vedotin (BLA)
FDA decision on Enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
03/15/2020
Seattle Genetics Inc.
Enfortumab vedotin (BLA)
FDA decision on Enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
03/15/2020
Merck & Co Inc.
V920 (BLA)
FDA decision on Ebola vaccine V920
03/14/2020
NewLink Genetics
V920 (BLA)
FDA decision on Ebola vaccine V920
03/14/2020
Horizon Pharma Inc
Teprotumumab (BLA)
FDA decision on Teprotumumab for the treatment of active thyroid eye disease
03/08/2020
BeiGene
Zanubrutinib (NDA)
FDA decision on Zanubrutinib for the treatment of patients with mantle cell lymphoma
02/27/2020
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)
02/26/2020
Global Blood Therapeutics
Voxelotor (NDA)
FDA decision on Voxelotor for the treatment of sickle cell disease
02/26/2020
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