Catalyst Pharmaceuticals autoimmune news

Catalyst reduced headcount by about 30% to conserve cash to complete requirements for an NDA submission for Firdapse amifampridine phosphate to treat Lambert-Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes. At March 11, Catalyst had 23 employees. The cuts came from the commercial team and include Chief Commercial Officer Paul Merrigan. In April, Catalyst said FDA requested an additional “adequate and well-controlled” trial to support an NDA for Firdapse. FDA issued a refusal to file letter for the NDA in February (see BioCentury, Feb. 22 & May 2). ...