secwatch.observer — SEC 8-K summary
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Issuer:     CATALYST PHARMACEUTICALS, INC. (CPRX)
CIK:        0001369568
Form:       8-K
Filed at:   2023-10-13T23:59:59+00:00
Accession:  0001193125-23-255742
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1369568/000119312523255742/0001193125-23-255742-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1369568/000119312523255742/d896301d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-255742

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer