---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-035343"
form_type: "8-K"
ticker: "ZVRA"
cik: "0001434647"
company_name: "ZEVRA THERAPEUTICS, INC."
filed_at: "2023-12-27T23:59:59+00:00"
generated_at: "2026-06-07T06:51:38.239233+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-23-035343
- form_type: 8-K
- ticker: ZVRA
- cik: 0001434647
- company_name: ZEVRA THERAPEUTICS, INC.
- filed_at: 2023-12-27T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- 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/1434647/000143774923035343/0001437749-23-035343-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1434647/000143774923035343/zvra20231226_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-035343
- JSON: https://secwatch.observer/filing/0001437749-23-035343.json
- Plain text: https://secwatch.observer/filing/0001437749-23-035343.txt

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