---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-006365"
form_type: "8-K"
ticker: "ZVRA"
cik: "0001434647"
company_name: "ZEVRA THERAPEUTICS, INC."
filed_at: "2024-03-04T23:59:59+00:00"
generated_at: "2026-06-05T04:40:11.095680+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-24-006365
- form_type: 8-K
- ticker: ZVRA
- cik: 0001434647
- company_name: ZEVRA THERAPEUTICS, INC.
- filed_at: 2024-03-04T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1434647/000143774924006365/0001437749-24-006365-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1434647/000143774924006365/zvra20240303_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-006365
- JSON: https://secwatch.observer/filing/0001437749-24-006365.json
- Plain text: https://secwatch.observer/filing/0001437749-24-006365.txt

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