regulatory
confidence high
sentiment neutral
materiality 0.70
Zevra announces FDA advisory committee meeting for arimoclomol on Aug 2, 2024
ZEVRA THERAPEUTICS, INC.
- FDA's Genetic Metabolic Diseases Advisory Committee (GeMDAC) will review arimoclomol NDA for Niemann-Pick disease type C.
- Meeting scheduled for August 2, 2024; background materials released two business days prior.
- PDUFA action date for arimoclomol is September 21, 2024.
- Arimoclomol is an orally delivered, first-in-class treatment for NPC, a rare genetic disease.
- Zevra CEO highlights opportunity for NPC community to share treatment needs with the advisory committee.