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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
Alnylam Pharmaceuticals Inc.
Givosiran (NDA)
FDA decision on Givosiran for the treatment of acute hepatic porphyria
02/04/2020
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
Alkermes plc
Vumerity (diroximel fumarate) (NDA)
FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis
12/25/2019
Acceleron Pharma, Inc
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with beta-thalassemia-associated anemia
12/04/2019
Celgene Corporation
Luspatercept (BLA)
FDA decision on Luspatercept for the treatment of MDS and Beta-Thalassemia-Associated Anemias
12/04/2019
Tesaro Inc.
Zejula (sNDA)
FDA decision on Zejula for the Late Stage Ovarian Cancer
10/24/2019
Melinta Therapeutics, Inc
BAXDELA (sNDA)
FDA decision on BAXDELA seeking to include adult patients with community-acquired bacterial pneumonia,
10/24/2019
Alexion Pharmaceuticals Inc.
Ultomiris (sBLA)
FDA decision on Ultomiris for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)
10/19/2019
Clearside Biomedical, Inc.
XIPERE (NDA)
FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
10/19/2019
Novartis AG
Brolucizumab (BLA)
FDA decision on Brolucizumab for the treatment of wet age-related macular degeneration
10/15/2019
Flexion Therapeutics, Inc.
ZILRETTA (sNDA)
FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
10/14/2019
Amarin Corp Plc
Vascepa (sNDA)
FDA decision on Vascepa to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol
09/28/2019
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
09/27/2019
Johnson & Johnson
Darzalex (sBLA)
FDA decision on Darzalex in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myelom
09/26/2019
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