Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma

CORAL GABLES, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq:CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that its collaboration partner, DyDo Pharma, Inc. (“DyDo”), reported that it has submitted a New Drug Application (“NDA”) to Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) seeking marketing approval for FIRDAPSE®  (amifampridine) Tablets 10 mg (generic name: amifampridine phosphate), for the treatment of Lambert Eaton myasthenic syndrome (“LEMS”) in Japan. The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS. The review period is expected to be approximately a minimum of nine months from the submission date.

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