Catalyst Pharmaceutical (CPRX) is higher by 10% in premarket action.
The company says it has completed a Type B meeting with the FDA regarding the LEMS treatment Firdapse.
CPRX says it updated the regulator on the drug's development program and "confirmed ... the clinical, nonclinical, and chemistry and manufacturing controls requirements that FDA will require to approve an NDA."
The company notes that after discussing "the acceptability of the primary and secondary endpoints specified in the protocol for the ongoing Phase 3 trial, the FDA requested a slight modification in the analyses to be conducted for the endpoints." CPRX does not see this as changing the data being collected and should not alter the number of patients "needed to complete enrollment." (PR)