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
Alnylam Pharmaceuticals Inc.
Givosiran (NDA)
FDA decision on Givosiran for the treatment of acute hepatic porphyria
Epizyme, Inc.
Tazemetostat (NDA)
FDA decision on Tazemetostat for the treatment of Epithelioid sarcoma
Novartis AG
Crizanlizumab (SEG101) (BLA)
FDA decision on crizanlizumab for the prevention of vaso-occlusive crises wih sickle cell disease
Alkermes plc
Vumerity (diroximel fumarate) (NDA)
FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis
Acceleron Pharma, Inc
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with beta-thalassemia-associated anemia
Celgene Corporation
Luspatercept (BLA)
FDA decision on Luspatercept for the treatment of MDS and Beta-Thalassemia-Associated Anemias
Tesaro Inc.
Zejula (sNDA)
FDA decision on Zejula for the Late Stage Ovarian Cancer
Melinta Therapeutics, Inc
FDA decision on BAXDELA seeking to include adult patients with community-acquired bacterial pneumonia,
Alexion Pharmaceuticals Inc.
Ultomiris (sBLA)
FDA decision on Ultomiris for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)
Clearside Biomedical, Inc.
FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
Novartis AG
Brolucizumab (BLA)
FDA decision on Brolucizumab for the treatment of wet age-related macular degeneration
Flexion Therapeutics, Inc.
FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
Amarin Corp Plc
Vascepa (sNDA)
FDA decision on Vascepa to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
Johnson & Johnson
Darzalex (sBLA)
FDA decision on Darzalex in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myelom
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