secwatch.observer — SEC 8-K summary
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Issuer:     CATALYST PHARMACEUTICALS, INC. (CPRX)
CIK:        0001369568
Form:       8-K
Filed at:   2024-05-30T23:59:59+00:00
Accession:  0001193125-24-150433
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1369568/000119312524150433/0001193125-24-150433-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1369568/000119312524150433/d831301d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-150433

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