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News Breaks
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.
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June 30, 2015
08:22 EDTCPRXCatalyst Pharmaceutical appoints Dr. Gary Ingenito as Chief Medical Officer
Catalyst Pharmaceuticals announced the appointment of Gary Ingenito, M.D., Ph.D, as Chief Medical Officer. Following Dr. Ingenito’s joining Catalyst, the current Chief Medical Officer, Charles Gorodetzky, M.D., Ph.D, will continue to serve as a consultant to the company.
June 29, 2015
08:07 EDTCPRXCatalyst Pharmaceutical study results encouraging, says SunTrust
SunTrust believes that data from a study of Catalyst's CPP-109 in patients with Refractory Tourette's Disorder was encouraging. The firm thinks the results provide strong proof-of-concept for the use of GABA minotransferase inhibitors in Tourette's Disorder. SunTrust says that the drug could enable the company's results to beat expectations by a significant amount. It keeps a Buy rating on the shares.
June 24, 2015
10:00 EDTCPRXOn The Fly: Analyst Initiation Summary
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09:22 EDTCPRXCatalyst Pharmaceutical initiated with a Buy at MLV & Co.
Target $14.
09:10 EDTCPRXOn The Fly: Pre-market Movers
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08:06 EDTCPRXCatalyst Pharmaceutical announces top-line results in vigabatrin trial
Catalyst Pharmaceuticals announced top-line results in an open-label, proof-of-concept trial of CPP-109, vigabatrin, used to treat patients suffering from Tourette's Disorder, or TD, that were refractory to all other previous treatments. One of four patients demonstrated a very clear, clinically significant reduction in tics, and two others showed about a 25% reduction in tics, but without subjective clinical improvement. This proof-of-concept trial of CPP-109 for Treatment-Refractory Tourette's Disorder was conducted by Barbara Coffey M.D., M.S., Co-Principal Investigator and Chief of the Tics and Tourette’s Clinical and Research Program at the Icahn School of Medicine at Mount Sinai in New York, in collaboration with Dr. Jonathan D. Brodie at the NYU Langone Medical Center, the Co-Principal Investigator and lead inventor of this use of GABA-AT inhibitors. The trial was designed to obtain preliminary data regarding clinical effect, dosage, and tolerability of vigabatrin in subjects at least 18 years of age with a DSM-IV-TR diagnosis of Tourette's Disorder, who exhibited unsatisfactory response to all prior treatments.

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