regulatory
confidence high
sentiment positive
materiality 0.60
Catalyst partner DyDo submits NDA in Japan for FIRDAPSE; milestone payment triggered
CATALYST PHARMACEUTICALS, INC.
- 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.