secwatch.observer — SEC 8-K summary
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Issuer:     CATALYST PHARMACEUTICALS, INC. (CPRX)
CIK:        0001369568
Form:       8-K
Filed at:   2023-12-19T23:59:59+00:00
Accession:  0001193125-23-298644
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Catalyst partner DyDo submits NDA in Japan for FIRDAPSE; milestone payment triggered
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- DyDo Pharma submitted NDA to PMDA for FIRDAPSE (amifampridine) 10 mg for LEMS in Japan.
- Submission based on favorable interim data after six months of the safety-phase registration study.
- Upon acceptance of NDA filing, Catalyst due JPY 200M (~$1.4M USD) milestone payment from DyDo.
- Territorial rights automatically expand to Asia, Central/South America; plans underway for global partnerships.
- PMDA review period expected to be a minimum of nine months from submission date.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1369568/000119312523298644/0001193125-23-298644-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1369568/000119312523298644/d676830d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-298644

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