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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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July 29, 2015
06:38 EDTBMRNBioMarin price target raised to $163 from $147 at Piper Jaffray
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July 22, 2015
13:26 EDTCPRXCatalyst Pharmaceutical initiates rolling NDA submission for Firdapse
Catalyst Pharmaceuticals announced the initiation of a rolling submission of a New Drug Application to the U.S. FDA for Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome. Firdapse has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS, as well as orphan drug designations for LEMS and congenital myasthenic syndromes. The company said, “We expect to complete the submission of the NDA in the fourth quarter of 2015, at which time we will be requesting a Priority Review of our application. We will continue to work closely with the FDA as we seek approval of the NDA."
July 21, 2015
07:59 EDTBMRNBioMarin gene therapy an overhang for Baxalta, says JPMorgan
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July 20, 2015
14:32 EDTBMRNFDA panel likely to review Sarepta, BioMarin drugs in November, TheStreet says
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11:03 EDTBMRNSarepta rises after Roth says added data can keep it ahead of BioMarin
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08:47 EDTBMRNBioMarin reports Abrazo Phase 2 trial met threshold for tumor reduction
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