regulatory
confidence high
sentiment positive
materiality 0.65
Catalyst earns $2.1M milestone as Japan approves FIRDAPSE for LEMS
CATALYST PHARMACEUTICALS, INC.
- 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.