---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-076358"
form_type: "8-K"
ticker: "CPRX"
cik: "0001369568"
company_name: "CATALYST PHARMACEUTICALS, INC."
filed_at: "2025-04-09T23:59:59+00:00"
generated_at: "2026-05-23T18:07:42.103557+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Catalyst Pharmaceuticals: Health Canada accepts AGAMREE NDS with Priority Review for DMD

## Summary
- Health Canada accepted New Drug Submission for AGAMREE (corticosteroid) for Duchenne muscular dystrophy.
- Submission granted Priority Review; potential marketing authorization before end of 2025.
- If approved, AGAMREE would be first and only DMD treatment indicated in Canada.
- AGAMREE already FDA-approved (Oct 2023) and commercially available in the U.S. since March 2024.
- Sub-licensee Kye Pharmaceuticals markets FIRDAPSE in Canada for LEMS.

## SEC filing metadata
- accession: 0001193125-25-076358
- form_type: 8-K
- ticker: CPRX
- cik: 0001369568
- company_name: CATALYST PHARMACEUTICALS, INC.
- filed_at: 2025-04-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1369568/000119312525076358/0001193125-25-076358-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1369568/000119312525076358/d941124d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-076358
- JSON: https://secwatch.observer/filing/0001193125-25-076358.json
- Plain text: https://secwatch.observer/filing/0001193125-25-076358.txt

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