Zevra resubmits NDA for arimoclomol (NPC) to FDA on Dec 22, 2023

ZEVRA THERAPEUTICS, INC.

FDA acknowledgment letter and PDUFA date expected within 30 days.
Resubmission classified as Class II; review targeted within six months.
Additional data includes non-clinical studies, natural history, real-world data, and 4-year open-label extension results.
Open-label extension data suggests arimoclomol reduces long-term NPC progression.
Arimoclomol evaluated in 21 studies across 600+ subjects.

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