secwatch.observer — SEC 8-K summary
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Issuer:     CATALYST PHARMACEUTICALS, INC. (CPRX)
CIK:        0001369568
Form:       8-K
Filed at:   2024-09-26T23:59:59+00:00
Accession:  0001193125-24-226538
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Catalyst earns $2.1M milestone as Japan approves FIRDAPSE for LEMS
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- Japan's Ministry of Health approved DyDo's NDA for FIRDAPSE (amifampridine) 10 mg to treat Lambert-Eaton myasthenic syndrome (LEMS).
- Catalyst receives JPY 300 million (~$2.1M) milestone payment from sub-licensee DyDo upon approval.
- FIRDAPSE is the only FDA-approved LEMS treatment in the U.S.; approval expands access to Japan.
- Catalyst CEO says approval underscores commitment to expanding rare disease product portfolio beyond the U.S.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1369568/000119312524226538/0001193125-24-226538-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1369568/000119312524226538/d841208d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-226538

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