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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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October 24, 2014
07:55 EDTBMRNBioMarin shares poised to rally, says RBC Capital
RBC Capital expects BioMarin's shares to rally into and through 2015, driven by 4-5 key pipeline events. The firm is especially upbeat on the outlook for Phase II achondroplasia data in 2Q15, as it thinks the product could show promising efficacy in dwarfism. The firm raised its price target on the name to $87 from $77 and keeps an Outperform rating on the shares.
07:44 EDTBMRNBioMarin price target raised to $87 from $74 at UBS
UBS raised its price target on BioMarin to $87 from $74 following its Q3 report and the firm believes the price target could be conservative based on the company's pipeline and its lower risk businesses. UBS reiterates its Buy rating on BioMarin shares.
05:50 EDTBMRNBioMarin remains a top mid cap pick at Piper Jaffray
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October 23, 2014
16:17 EDTBMRNBioMarin lowers FY14 adjusted net loss to ($65M)-($50M) from ($80M)-($60M)
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16:15 EDTBMRNBioMarin raises FY14 revenue view to $700M-$710M from $680M-$700M
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16:13 EDTBMRNBioMarin reports Q3 adjusted EPS (16c), consensus (23c)
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15:30 EDTBMRNNotable companies reporting after market close
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October 21, 2014
09:48 EDTBMRNShire could target BioMarin, TheStreet's Feuerstein says
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October 20, 2014
07:10 EDTBMRNAmerican Society of Human Genetics to hold annual meeting
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October 13, 2014
07:33 EDTCPRXAmerican Neurological Association to hold annual meeting
ANA 2014: 139th Annual Meeting is being held in Baltimore on October 12-14.

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