FDA accepts Zevra's NDA resubmission for arimoclomol (NPC); PDUFA date June 21, 2024

ZEVRA THERAPEUTICS, INC.

FDA deems resubmission a Class II complete response with 6-month review; PDUFA date June 21, 2024.
FDA intends to present arimoclomol NDA for discussion at an advisory committee meeting.
Resubmission addresses previous CRL concerns with additional trial metrics, preferred analyses, and supporting studies.
Arimoclomol is an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.

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