FDA extends arimoclomol review; new PDUFA date Sept 21, 2024

ZEVRA THERAPEUTICS, INC.

FDA extended review of arimoclomol NDA for Niemann-Pick disease type C; new PDUFA action date Sept 21, 2024 (was June 21, 2024).
FDA determined additional analyses submitted by Zevra constitute a Major Amendment, causing the extension.
FDA reaffirmed intent to present the resubmission at an advisory committee meeting to be scheduled.
CEO McFarlane notes NPC patient advocacy petition; early access program continues.
Zevra previously announced acceptance of NDA resubmission in early January 2024.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.