---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-024543"
form_type: "8-K"
ticker: "ZVRA"
cik: "0001434647"
company_name: "ZEVRA THERAPEUTICS, INC."
filed_at: "2024-08-05T23:59:59+00:00"
generated_at: "2026-05-31T13:03:18.833917+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-24-024543
- form_type: 8-K
- ticker: ZVRA
- cik: 0001434647
- company_name: ZEVRA THERAPEUTICS, INC.
- filed_at: 2024-08-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1434647/000143774924024543/0001437749-24-024543-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1434647/000143774924024543/zvra20240802_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-024543
- JSON: https://secwatch.observer/filing/0001437749-24-024543.json
- Plain text: https://secwatch.observer/filing/0001437749-24-024543.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.