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April 1, 2014
08:22 EDTCPRXCatalyst Pharmaceutical completes patient enrollment for Firdapse Phase 3 trial
Catalyst Pharmaceutical Partners announced that it has reached the patient enrollment target for its pivotal Phase 3 trial evaluating the safety and efficacy of Firdapse for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome, or LEMS. Based on the enrollment and randomization success metrics achieved to date, the Company believes that it has enrolled a sufficient number of LEMS patients to ensure that 36 patients will be randomized into the double-blind, placebo-controlled, discontinuation portion of the trial.
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July 22, 2015
13:26 EDTCPRXCatalyst Pharmaceutical initiates rolling NDA submission for Firdapse
Catalyst Pharmaceuticals announced the initiation of a rolling submission of a New Drug Application to the U.S. FDA for Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome. Firdapse has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS, as well as orphan drug designations for LEMS and congenital myasthenic syndromes. The company said, “We expect to complete the submission of the NDA in the fourth quarter of 2015, at which time we will be requesting a Priority Review of our application. We will continue to work closely with the FDA as we seek approval of the NDA."

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