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
Verrica Pharmaceuticals Inc.
VP-102 (cantharidin 0.7% Topical Solution) (NDA)
FDA decision on VP-102 for the Treatment of Molluscum Contagiosum
Endo International plc
Collagenase clostridium histolyticum (BLA)
FDA decision on collagenase clostridium histolyticum (CCH) for cellulite in buttocks
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
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
Sumitomo Dainippon Pharma
Dasotraline (NDA)
FDA decision on Dasotraline for the treatment of patients with moderate-to-severe binge eating disorder
Halozyme Therapeutics, Inc.
FDA decision on subcutaneous delivery of DARZALEX for patients with multiple myeloma.
Isatuximab (BLA)
FDA decision on Isatuximab b for the treatment of patients with relapsed/refractory multiple myeloma
United Therapeutics Corp
Trevyent (UTHR)
FDA decision on Trevyent for the treatment of pulmonary arterial hypertension
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