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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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July 2, 2015
13:59 EDTBMRNNHS to wait on NICE to make call on PTC Therapeutics, BioMarin drugs
NHS England has set out its planned investment decisions for certain specialized services as part of its annual commissioning round. NHS England has agreed with the recommendations from CPAG that final funding decisions on the following two treatments should be made after NICE has concluded its Highly Specialized Technology Appraisal process: BioMarin Pharmaceutical's (BMRN) Vimizim for Morquio A Syndrome and PTC Therapeutics' (PTCT) Translarna for Duchenne muscular dystrophy. The decisions on those two drugs came among 39 proposed new investments that the group said were "carefully considered against the principles NHS England follows when making investment decisions." Reference Link
June 30, 2015
08:22 EDTCPRXCatalyst Pharmaceutical appoints Dr. Gary Ingenito as Chief Medical Officer
Catalyst Pharmaceuticals announced the appointment of Gary Ingenito, M.D., Ph.D, as Chief Medical Officer. Following Dr. Ingenito’s joining Catalyst, the current Chief Medical Officer, Charles Gorodetzky, M.D., Ph.D, will continue to serve as a consultant to the company.
June 29, 2015
12:53 EDTBMRNSarepta NDA submission for eteplirsen done ahead of schedule, says Piper Jaffray
Piper Jaffray noted that Sarepta (SRPT) completed its rolling NDA submission for eteplirsen ahead of schedule and the firm believes that concurrent advisory committee meetings for its DMD drug and BioMarin's (BMRN) drisapersen could take place this fall. The firm has a Neutral rating and $20 price target on Sarepta and Overweight rating and $147 target on BioMarin.
08:36 EDTBMRNBioMarin announces FDA acceptance of drisapersen NDA
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08:07 EDTCPRXCatalyst Pharmaceutical study results encouraging, says SunTrust
SunTrust believes that data from a study of Catalyst's CPP-109 in patients with Refractory Tourette's Disorder was encouraging. The firm thinks the results provide strong proof-of-concept for the use of GABA minotransferase inhibitors in Tourette's Disorder. SunTrust says that the drug could enable the company's results to beat expectations by a significant amount. It keeps a Buy rating on the shares.
June 25, 2015
16:03 EDTBMRNBioMarin announces EMA validates MAA for drisapersen for treatment of DMD
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June 24, 2015
10:00 EDTCPRXOn The Fly: Analyst Initiation Summary
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09:22 EDTCPRXCatalyst Pharmaceutical initiated with a Buy at MLV & Co.
Target $14.
09:10 EDTCPRXOn The Fly: Pre-market Movers
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08:06 EDTCPRXCatalyst Pharmaceutical announces top-line results in vigabatrin trial
Catalyst Pharmaceuticals announced top-line results in an open-label, proof-of-concept trial of CPP-109, vigabatrin, used to treat patients suffering from Tourette's Disorder, or TD, that were refractory to all other previous treatments. One of four patients demonstrated a very clear, clinically significant reduction in tics, and two others showed about a 25% reduction in tics, but without subjective clinical improvement. This proof-of-concept trial of CPP-109 for Treatment-Refractory Tourette's Disorder was conducted by Barbara Coffey M.D., M.S., Co-Principal Investigator and Chief of the Tics and Tourette’s Clinical and Research Program at the Icahn School of Medicine at Mount Sinai in New York, in collaboration with Dr. Jonathan D. Brodie at the NYU Langone Medical Center, the Co-Principal Investigator and lead inventor of this use of GABA-AT inhibitors. The trial was designed to obtain preliminary data regarding clinical effect, dosage, and tolerability of vigabatrin in subjects at least 18 years of age with a DSM-IV-TR diagnosis of Tourette's Disorder, who exhibited unsatisfactory response to all prior treatments.
June 23, 2015
07:49 EDTBMRNPTC Therapeutics risk lowered by symposium, says Oppenheimer
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07:25 EDTBMRNPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.

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