Catalyst Pharmaceuticals, Inc. (CPRX): FDA OKs Phase 3 Firdapse Study; Shares Higher
Shares of Catalyst Pharmaceuticals (NASDAQ: CPRX) are 11% higher after the biopharmaceutical company announced its agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach of the company’s upcoming phase 3 study evaluating Firdapse® for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). Calling the SPA a “major milestone,” Catalyst CEO Patrick J. McEnany said the company now has a regulatory pathway for Firdapse. Catalyst expects to initiate this trial before the end of this year. To view the full press release, visit: http://nnw.fm/S3sgt About…







