---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-000822"
form_type: "8-K"
ticker: "ZVRA"
cik: "0001434647"
company_name: "ZEVRA THERAPEUTICS, INC."
filed_at: "2024-01-08T23:59:59+00:00"
generated_at: "2026-06-07T02:09:41.987969+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Zevra's NDA resubmission for arimoclomol (NPC); PDUFA date June 21, 2024

## Summary
- FDA deems resubmission a Class II complete response with 6-month review; PDUFA date June 21, 2024.
- FDA intends to present arimoclomol NDA for discussion at an advisory committee meeting.
- Resubmission addresses previous CRL concerns with additional trial metrics, preferred analyses, and supporting studies.
- Arimoclomol is an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.

## SEC filing metadata
- accession: 0001437749-24-000822
- form_type: 8-K
- ticker: ZVRA
- cik: 0001434647
- company_name: ZEVRA THERAPEUTICS, INC.
- filed_at: 2024-01-08T23:59:59+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/1434647/000143774924000822/0001437749-24-000822-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1434647/000143774924000822/zvra20240107_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-000822
- JSON: https://secwatch.observer/filing/0001437749-24-000822.json
- Plain text: https://secwatch.observer/filing/0001437749-24-000822.txt

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