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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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August 26, 2014
18:20 EDTBMRNOn The Fly: After Hours Movers
UP AFTER EARNINGS: TubeMogul (TUBE), up 31.8% after reporting better than expected second quarter results and guidance above analyst estimates... Aruba Networks (ARUN), up 2.3% after reporting quarterly results and announcing a 3.7% workforce reduction... HEICO (HEI), up 2.3% after raising fiscal 2014 net income guidance. ALSO HIGHER: Chemtura (CHMT) and Diebold (DBD) are both up marginally after Mario Gabelli commented on the companies in an interview with CNBC. DOWN AFTER EARNINGS: Smith & Wesson (SWHC), down 10.2% after reporting disappointing first quarter results and lowering fiscal 2014 outlook. ALSO LOWER: Sturm, Ruger (RGR), down 4% after Smith & Wesson reported quarterly results... BioMarin (BMRN), down 1.35 after lowering fiscal 2014 revenue guidance.
16:36 EDTBMRNBioMarin lowers FY14 revenue view to $680M-$700M from $745M-$765M
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