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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
Intercept Pharmaceuticals Inc.
Obeticholic acid (NDA)
FDA decision on obeticholic acid for fibrosis due to nonalcoholic steatohepatitis
06/26/2020
Zogenix, Inc.
FINTEPLA (NDA)
FDA decision on FINTEPLA for the treatment of seizures associated with Dravet syndrome
06/25/2020
Takeda Pharmaceutical Company Limited
TKPHF.PK, TAK
ALUNBRIG (NDA)
FDA decision on ALUNBRIG as first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC
06/23/2020
GlaxoSmithKline PLC
GSK.L, GSK
Belantamab mafodotin (BLA)
FDA decision on Belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma
06/19/2020
Evoke Pharma, Inc.
GimotI (NDA resubmission)
FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
06/19/2020
Viela Bio
Inebilizumab (BLA)
FDA decision on Inebilizumab the treatment of neuromyelitis optica spectrum disorder
06/11/2020
Viela Bio
Inebilizumab (BLA)
FDA decision on Inebilizumab for treatment of patients with neuromyelitis optica spectrum disorder (
06/11/2020
Foamix Pharmaceuticals Ltd.
FMX103 topical foam (NDA)
FDA decision on FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults.
06/02/2020
Immunomedics Inc.
Sacituzumab Govitecan (Resubmission BLA)
FDA decision on Sacituzumab Govitecan for patients with Metastatic Triple-Negative Breast Cancer
06/02/2020
Incyte Corporation
Pemigatinib (NDA)
FDA decision on Pemigatinib for patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions
05/30/2020
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
05/26/2020
PTC Therapeutics Inc.
Risdiplam (NDA)
FDA decision on Risdiplam for the treatment of spinal muscular atrophy
05/24/2020
Roche Holding AG
Risdiplam (NDA)
FDA decision on risdiplam for spinal muscular atrophy
05/24/2020
Blueprint Medicines
Avapritinib (NDA)
FDA decision on Avapritinib for the treatment of adult patients with fourth-line gastrointestinal stromal tumor (GIST)
05/14/2020
Sumitomo Dainippon Pharma
Dasotraline (NDA)
FDA decision on Dasotraline for the treatment of patients with moderate-to-severe binge eating disorder
05/14/2020
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