FDA panel votes 11-5 that Zevra's arimoclomol is effective for NPC; PDUFA date Sep 21

ZEVRA THERAPEUTICS, INC.

FDA GeMDAC voted 11 yes, 5 no that data support arimoclomol as effective for Niemann-Pick disease type C.
PDUFA action date for arimoclomol NDA is September 21, 2024.
The committee’s recommendation is non-binding but will be considered by the FDA.
Vote based on pivotal trial, long-term open-label extension, and expanded access program data.
Zevra CEO expresses confidence in arimoclomol's clinical benefit and path to approval.

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