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February 11, 2013
08:08 EDTCPRXCatalyst Pharmaceutical provides update on RND pipeline
Catalyst Pharmaceutical Partners, provided an update on its research and development pipeline. In October 2012, Catalyst acquired the North American rights to Firdapse, a proprietary form of amifampridine phosphate from BioMarin Pharmaceutical. Firdapse was approved in December 2009 by the European Medicines Agency for the treatment of Lambert-Eaton Myasthenic Syndrome, or LEMS, a rare and sometimes fatal autoimmune disease characterized by muscle weakness. Firdapse has been granted orphan drug designation by the FDA for the treatment of LEMS, making the product eligible to obtain seven-year marketing exclusivity, if Catalyst is the first pharmaceutical company to obtain approval of an NDA for its formulation of amifampridine. Assuming positive results are obtained from the trial, Catalyst hopes to file an NDA for Firdapse in 1Q15, to obtain approval from the FDA of such NDA by the end of 2015, and to commercially launch this product sometime in the first half of 2016.Catalyst believes Firdapse can achieve peak annual revenues from sales in the U.S. of approximately $100M. On August 27, 2009, Catalyst entered into a license agreement with Northwestern University (Northwestern), under which it acquired worldwide rights to commercialize new GABA aminotransferase inhibitors and derivatives of vigabatrin which were discovered and patented by Northwestern. In October 2011, a pre-IND meeting was conducted with the FDA, during which preclinical and clinical requirements were defined that would allow Catalyst to complete a development program through Phase II of CPP-115 for the treatment of infantile spasms.
News For CPRX From The Last 14 Days
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September 30, 2014
11:18 EDTCPRXCatalyst Pharmaceutical shares undervalued, says H.C. Wainwright
09:10 EDTCPRXOn The Fly: Pre-market Movers
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05:41 EDTCPRXCatalyst Pharmaceutical to host conference call
Conference call to discuss positive top-line results from the Firdapse clinical trial will be held on September 30 at 8:30 am. Webcast Link
September 29, 2014
18:22 EDTCPRXOn The Fly: After Hours Movers
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17:08 EDTCPRXCatalyst Pharmaceutical up 24% after hours following positive Firdapse data
16:05 EDTCPRXCatalyst Pharmaceutical: Results from Phase 3 trial of Firdapse met co-endpoints
Catalyst Pharmaceutical announced positive top-line results from the pivotal Phase 3 clinical trial of Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome. Both co-primary endpoints, quantitative myasthenia gravis score and subject global impression, demonstrated that Firdapse was significantly superior to placebo, as did a secondary endpoint for the physician's clinical global impression of improvement. This clinical trial was designed as a double blind, randomized, "withdrawal trial" in which all patients were initially treated with Firdapse during a 91 day run-in period followed by treatment with either Firdapse or placebo during a 2 week randomization period. A total of 38 patients completed the 3 month run-in period and subsequent 2 week randomization period. In a trial of this design, the clinically significant findings, when present, are worsening of symptoms in the placebo group.
16:00 EDTCPRXCatalyst Pharmaceutical trading halted, pending news
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09:53 EDTCPRXCatalyst Pharmaceutical management to meet with Roth Capital
Meeting to be held in San Francisco on October 6 hosted by Roth Capital.

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