INCY - FDA accepts to review Incyte's NDA for parsaclisib

Incyte (NASDAQ:INCY) announces that the U.S. FDA has accepted its New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K?). The NDA for use of parsaclisib will have a Standard Review and a PDUFA target action date of August 30, 2022. The submission is based on data from several Phase 2 studies evaluating parsaclisib as a treatment for relapsed or refractory non-Hodgkin lymphomas ((NHLs)) ((FL, MZL and MCL)). Shares up marginally premarket.

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FDA accepts to review Incyte's NDA for parsaclisib