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News Breaks
April 18, 2013
08:28 EDTCPRXCatalyst Pharmaceutical initiated with a Buy at Aegis
Target $2.50.
News For CPRX From The Last 14 Days
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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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