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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
Acceleron Pharma, Inc
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with very low- to intermediate-risk MDS-associated anemia
04/04/2020
Rockwell Medical Technologies Inc
IV Triferic (NDA)
FDA decision on IV Triferic for iron deficiency in chronic kidney disease patients receiving hemodialysis
03/28/2020
Celgene Corporation
Ozanimod (NDA)
FDA decision on Ozanimod for Treatment of Relapsing Forms of Multiple Sclerosis
03/25/2020
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
ALDER BIOPHARMACEUTICALS INC
Eptinezumab (BLA)
FDA decision on Eptinezumab for migraine prevention
02/21/2020
Merck & Co Inc.
Keytruda (pembrolizumab) (sBLA)
FDA decision on Keytruda for melanoma and multiple other indications
02/18/2020
Alnylam Pharmaceuticals Inc.
Givosiran (NDA)
FDA decision on Givosiran for the treatment of acute hepatic porphyria
02/04/2020
Merck & Co Inc.
DIFICID (NDA)
FDA decision on DIFICID for oral suspension for Clostridium difficile infections
01/24/2020
Merck & Co Inc.
DIFICID (sNDA)
FDA decision on DIFICID tablets and oral suspension for Clostridium difficile infections in children
01/24/2020
Epizyme, Inc.
Tazemetostat (NDA)
FDA decision on Tazemetostat for the treatment of Epithelioid sarcoma
01/23/2020
Novartis AG
Crizanlizumab (SEG101) (BLA)
FDA decision on crizanlizumab for the prevention of vaso-occlusive crises wih sickle cell disease
01/15/2020
Amarin Corp Plc
Vascepa (sNDA)
FDA decision on expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study.
12/28/2019
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