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News Breaks
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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November 14, 2014
08:12 EDTCPRXCatalyst Pharmaceutical reports Q3 EPS (6c), consensus (5c)
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November 13, 2014
16:50 EDTCPRXCatalyst Pharmaceutical reports Q3 EPS (7c), consensus (5c)
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November 12, 2014
07:53 EDTBMRNLeerink to hold a tour
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November 10, 2014
10:04 EDTBMRNOn The Fly: Analyst Upgrade Summary
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06:02 EDTBMRNBioMarin upgraded to Buy from Neutral at Goldman
Goldman upgraded BioMarin to Buy based on increased confidence in BMN-111 for achondroplasia with expected proof-of-concept data in Q2 2015. The firm now sees a greater than 50% probability of success and peak sales of $900M. Price target raised to $104 from $78.

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