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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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January 12, 2015
08:30 EDTCPRXCatalyst Pharmaceutical announces FY15 goals
Catalyst Pharmaceutical announced the company's 2015 goals for its product portfolio. Firdapse has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA for the treatment of Lambert-Eaton Myasthenic Syndrome, or LEMS, and reported positive results from its Phase 3 clinical trial evaluating Firdapse for the treatment of LEMS in September 2014. The company has also initiated an expanded access program, or EAP, under which patients with LEMS and Congenital Myasthenic Syndrome, or CMS, who meet the inclusion/exclusion requirements, have access to Firdapse via the EAP, at no charge to the patients. Catalyst expects to meet with the FDA for its pre-NDA meeting in Q1, to begin its rolling NDA submission for Firdapse for the treatment of LEMS sometime thereafter and to complete its NDA submission sometime in Q3. Catalyst expects to achieve the following key milestones in the upcoming year: The company will continue to focus on pre-commercial activities ahead of an estimated approval and launch of Firdapse in 1H16.

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