Apellis Announces FDA Acceptance and Priority Review of the Supplemental New Drug Application for EMPAVELI® (pegcetacoplan) for C3G and Primary IC-MPGN

WALTHAM, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI^® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. The Prescription Drug User Fee Act (PDUFA) target action date is July 28, 2025.

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