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News Breaks
January 8, 2014
08:16 EDTCPRX, BMRNCatalyst, 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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October 21, 2014
09:48 EDTBMRNShire could target BioMarin, TheStreet's Feuerstein says
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October 20, 2014
07:10 EDTBMRNAmerican Society of Human Genetics to hold annual meeting
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October 13, 2014
07:33 EDTCPRXAmerican Neurological Association to hold annual meeting
ANA 2014: 139th Annual Meeting is being held in Baltimore on October 12-14.

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