---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-255742"
form_type: "8-K"
ticker: "CPRX"
cik: "0001369568"
company_name: "CATALYST PHARMACEUTICALS, INC."
filed_at: "2023-10-13T23:59:59+00:00"
generated_at: "2026-06-09T23:56:05.570189+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Catalyst's sNDA to increase FIRDAPSE max dose to 100 mg; PDUFA June 4, 2024

## Summary
- FDA accepted supplemental NDA to increase FIRDAPSE maximum daily dose from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome.
- Prescription Drug User Fee Act action date set for June 4, 2024.
- FIRDAPSE is currently approved for adults and children ages 6-17 with LEMS.
- Chairman and CEO Patrick J. McEnany highlighted the milestone for addressing patient needs.

## SEC filing metadata
- accession: 0001193125-23-255742
- form_type: 8-K
- ticker: CPRX
- cik: 0001369568
- company_name: CATALYST PHARMACEUTICALS, INC.
- filed_at: 2023-10-13T23:59:59+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/1369568/000119312523255742/0001193125-23-255742-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1369568/000119312523255742/d896301d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-255742
- JSON: https://secwatch.observer/filing/0001193125-23-255742.json
- Plain text: https://secwatch.observer/filing/0001193125-23-255742.txt

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