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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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December 12, 2014
08:01 EDTBMRNPiper predicts two large-cap biotechs could be acquired in 2015
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December 11, 2014
10:21 EDTBMRNHigh option volume stocks
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07:46 EDTBMRNBioMarin could be $150 in 'blue skies' scenario, says UBS
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07:35 EDTBMRNBioMarin price target raised to $107 from $92 at Leerink
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07:24 EDTBMRNBioMarin price target raised to $104 from $90 at William Blair
William Blair raised its price target for BioMarin shares to $104 following the company's R&D day and keeps an Outperform rating on the stock. The firm expects the Vimizim launch to remain strong and believes BioMarin holds one of the strongest pipelines in the sector.
07:19 EDTBMRNBioMarin price target raised to $118-$122 from $103-$107 at Wells Fargo
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December 10, 2014
08:14 EDTBMRNBioMarin VIMIZIM approved in Brazil
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08:13 EDTBMRNBioMarin NAGLU granted ODD by FDA
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December 9, 2014
12:22 EDTBMRNPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
07:44 EDTBMRNAmerican Association for Cancer Research to hold a symposium
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