---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-029747"
form_type: "8-K"
ticker: "ZVRA"
cik: "0001434647"
company_name: "ZEVRA THERAPEUTICS, INC."
filed_at: "2024-09-20T23:59:59+00:00"
generated_at: "2026-05-31T02:46:10.926269+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Zevra Therapeutics' MIPLYFFA receives FDA approval as first treatment for Niemann-Pick disease type C

## Summary
- FDA approved MIPLYFFA (arimoclomol) for NPC in adult and pediatric patients 2 years+; first FDA-approved NPC treatment.
- MIPLYFFA is indicated for use in combination with miglustat for neurological manifestations of NPC.
- Zevra received a rare pediatric disease priority review voucher (PRV) with the approval.
- Launch of AmplifyAssist patient support program; MIPLYFFA expected commercially available in 8-12 weeks.
- Conference call and webcast on Sept 23, 2024 at 8 a.m. ET to discuss approval.

## SEC filing metadata
- accession: 0001437749-24-029747
- form_type: 8-K
- ticker: ZVRA
- cik: 0001434647
- company_name: ZEVRA THERAPEUTICS, INC.
- filed_at: 2024-09-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1434647/000143774924029747/0001437749-24-029747-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1434647/000143774924029747/zvra20240920_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-029747
- JSON: https://secwatch.observer/filing/0001437749-24-029747.json
- Plain text: https://secwatch.observer/filing/0001437749-24-029747.txt

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