regulatory
confidence high
sentiment positive
materiality 0.75
FDA approves higher max daily dose of FIRDAPSE for LEMS to 100 mg
CATALYST PHARMACEUTICALS, INC.
- 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.