---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-265168"
form_type: "8-K"
ticker: "CPRX"
cik: "0001369568"
company_name: "CATALYST PHARMACEUTICALS, INC."
filed_at: "2023-10-27T23:59:59+00:00"
generated_at: "2026-06-09T06:51:22.874940+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Catalyst reports FDA approval of AGAMREE for DMD; expects Q1 2024 launch

## Summary
- Santhera received FDA approval for AGAMREE (vamorolone) oral suspension 40 mg/mL for DMD in patients aged 2+.
- Catalyst holds exclusive North American license; NDA transfer from Santhera to Catalyst is prompt.
- Catalyst expects to commercially launch AGAMREE in Q1 2024 with a patient assistance program.
- AGAMREE has orphan drug exclusivity (7 years) and patent protection potentially until 2040.
- Approval based on Phase 2b VISION-DMD study and open-label extension data up to 48 months.

## SEC filing metadata
- accession: 0001193125-23-265168
- form_type: 8-K
- ticker: CPRX
- cik: 0001369568
- company_name: CATALYST PHARMACEUTICALS, INC.
- filed_at: 2023-10-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1369568/000119312523265168/0001193125-23-265168-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1369568/000119312523265168/d577328d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-265168
- JSON: https://secwatch.observer/filing/0001193125-23-265168.json
- Plain text: https://secwatch.observer/filing/0001193125-23-265168.txt

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