Catalyst's Firdapse gets Priority Review in U.S.

Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) said FDA accepted and granted Priority Review to a resubmitted NDA for Firdapse amifampridine phosphate to treat Lambert-Eaton myasthenic syndrome (LEMS). The PDUFA date is Nov. 28.

In 2016, the agency issued a refusal-to-file letter for Firdapse to treat LEMS and congenital myasthenic syndromes, requiring a second trial in patients with LEMS and several abuse liability studies. Catalyst plans to pursue approval for congenital myasthenic syndromes after completing an ongoing trial, according to an SEC filing. It expects top-line Phase III data in 1Q19...