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January 8, 2014
08:16 EDTBMRN, CPRXCatalyst, BioMarin report phase 3 Firdapse study meets primary endpoint
Catalyst Pharmaceutical (CPRX) announced results from a study jointly funded with, and conducted by BioMarin Pharmaceuticals (BMRN) to assess the cardiac safety of Firdapse tablets. Firdapse is approved in the E.U., where it is marketed by BioMarin. Firdapse is also currently in Phase 3 development in the U.S. for Lambert-Eaton Myasthenic Syndrome by Catalyst. The study met the pre-specified primary endpoint, demonstrating that at and above therapeutic levels, there was no effect of Firdapse on heart rate or cardiac depolarization. None of the study subjects developed new, clinically relevant electrocardiographic/morphological changes following administration of Firdapse. Additionally, there was no significant effect of Firdapse on cardiac repolarization as assessed using the QT interval. At a pre-IND meeting in 2010, FDA requested TQT study results for Firdapse at exposures higher than typical therapeutic levels be included as part of the clinical safety package in any New Drug Application filed for 3,4-DAP. Charles Gorodetzky, the Chief Medical Officer for Catalyst, said, "This study was designed in accordance with existing FDA guidelines. We are confident in these results and will continue to work toward making Firdapse available to patients in the U.S. if we are able to obtain marketing authorization from FDA."
News For CPRX;BMRN From The Last 14 Days
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April 14, 2014
10:02 EDTCPRXOn The Fly: Analyst Initiation Summary
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08:22 EDTBMRNBioMarin says FDA extends Kuvan market exclusivity by six months
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07:14 EDTCPRXCatalyst Pharmaceutical initiated with an Overweight at Piper Jaffray
Target $4.
April 7, 2014
10:04 EDTBMRNBioMarin well positioned for revenue growth, says Summer Street
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April 3, 2014
09:05 EDTCPRXCatalyst Pharmaceutical 11.3M share Spot Secondary priced at $2.21
Piper Jaffray acted as sole book running manager for the offering.

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