---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-150433"
form_type: "8-K"
ticker: "CPRX"
cik: "0001369568"
company_name: "CATALYST PHARMACEUTICALS, INC."
filed_at: "2024-05-30T23:59:59+00:00"
generated_at: "2026-06-01T07:21:22.271005+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA approves higher max daily dose of FIRDAPSE for LEMS to 100 mg

## Summary
- FDA approved sNDA increasing FIRDAPSE max daily dose from 80 mg to 100 mg for adults and peds >45 kg with LEMS.
- FIRDAPSE is the only U.S.-approved treatment for LEMS; expanded dosing offers greater treatment flexibility.
- CEO Richard Daly states approval will have meaningful impact on LEMS patient outcomes.
- Catalyst Pathways patient support program available for eligible patients.

## SEC filing metadata
- accession: 0001193125-24-150433
- form_type: 8-K
- ticker: CPRX
- cik: 0001369568
- company_name: CATALYST PHARMACEUTICALS, INC.
- filed_at: 2024-05-30T23:59:59+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/1369568/000119312524150433/0001193125-24-150433-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1369568/000119312524150433/d831301d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-150433
- JSON: https://secwatch.observer/filing/0001193125-24-150433.json
- Plain text: https://secwatch.observer/filing/0001193125-24-150433.txt

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