New User:

Forgot your password?

Stock Market & Financial Investment News

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
Sign up for a free trial to see the rest of the stories you've been missing.
April 27, 2015
09:44 EDTBMRNBioMarin completes rolling NDA submission to FDA for drisapersen for DMD
Subscribe for More Information
09:05 EDTCPRXCatalyst Pharmaceutical should be bought on weakness, says SunTrust
Subscribe for More Information
April 24, 2015
16:56 EDTCPRXCatalyst director Charles O'Keeffe buys 5,000 shares of common stock
Subscribe for More Information
14:44 EDTCPRXCatalyst slips after competitor surprises with positive data, TheStreet says
Shares of Catalyst Pharmaceutical are falling after its privately held competitor, Jacobus Pharmaceuticals, surprised with the disclosure of positive clinical trial data showing "unequivocal evidence" that its experimental drug is an effective treatment for patients with Lambert-Eaton Myasthenic Syndrome, said TheStreet's Adam Feuerstein. Jacobus Pharma's drug, which can now reportedly be submitted to FDA for approval, has the same active ingredient as in Firdapse, the report added. Shares of Catalyst are down about 17% to $3.88 in afternoon trading. Reference Link
14:33 EDTCPRXCatalyst Pharmaceutical weakness a buying opportunity, says Piper Jaffray
Piper Jaffray expects Catalyst Pharmaceutical's Firdapse to gain approval first and secure Orphan designation for Lambert-Eaton myasthenic syndrome. The firm reiterates its Overweight rating and $7 price target and would be buyers on weakness.
April 21, 2015
14:00 EDTBMRNOptions with decreasing implied volatility
Options with decreasing implied volatility: NFLX MLNX XON WUBA MEMP BMRN FTNT BPT SNDK
April 20, 2015
10:11 EDTBMRNOptions with decreasing implied volatility
Options with decreasing implied volatility: BPT WETF NFLX BMRN SNDK STX TSM MAT FAST INTC
07:18 EDTBMRNAmerican Academy of Neurology to hold annual meeting
Subscribe for More Information
April 17, 2015
10:14 EDTBMRNOptions with decreasing implied volatility
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the disclaimer & terms of use