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
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
Takeda Pharmaceutical Company Limited
FDA decision on ALUNBRIG as first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC
GlaxoSmithKline PLC
Belantamab mafodotin (BLA)
FDA decision on Belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma
Evoke Pharma, Inc.
GimotI (NDA resubmission)
FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
Viela Bio
Inebilizumab (BLA)
FDA decision on Inebilizumab the treatment of neuromyelitis optica spectrum disorder
Viela Bio
Inebilizumab (BLA)
FDA decision on Inebilizumab for treatment of patients with neuromyelitis optica spectrum disorder (
Foamix Pharmaceuticals Ltd.
FMX103 topical foam (NDA)
FDA decision on FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults.
Immunomedics Inc.
Sacituzumab Govitecan (Resubmission BLA)
FDA decision on Sacituzumab Govitecan for patients with Metastatic Triple-Negative Breast Cancer
Incyte Corporation
Pemigatinib (NDA)
FDA decision on Pemigatinib for patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on Dupixent as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
PTC Therapeutics Inc.
Risdiplam (NDA)
FDA decision on Risdiplam for the treatment of spinal muscular atrophy
Roche Holding AG
Risdiplam (NDA)
FDA decision on risdiplam for spinal muscular atrophy
Blueprint Medicines
Avapritinib (NDA)
FDA decision on Avapritinib for the treatment of adult patients with fourth-line gastrointestinal stromal tumor (GIST)
Sumitomo Dainippon Pharma
Dasotraline (NDA)
FDA decision on Dasotraline for the treatment of patients with moderate-to-severe binge eating disorder
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