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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."
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April 17, 2014
17:02 EDTBMRN, CPRXCatalyst Pharmaceutical, BioMarin in amended license agreement
Catalyst Pharmaceutical (CPRX) disclosed in a regulatory filing that on April 15, effective as of April 8, the company and BioMarin Pharmaceutical (BMRN) entered into Amendment No. 1 to License Agreement, amending in certain respects the License Agreement, dated October 26, 2012, between the company and BioMarin. The company intends to submit a FOIA Confidential Treatment Request to the SEC pursuant to Rule 24b-2 under the SEC Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Amendment. The omitted material will be included in the request for confidential treatment.
April 14, 2014
10:02 EDTCPRXOn The Fly: Analyst Initiation Summary
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08:22 EDTBMRNBioMarin says FDA extends Kuvan market exclusivity by six months
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07:14 EDTCPRXCatalyst Pharmaceutical initiated with an Overweight at Piper Jaffray
Target $4.

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