New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

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
Check below for free stories on CPRX;BMRN the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
September 18, 2014
12:18 EDTBMRNPiper Jaffray biopharm analyst holds an analyst/industry conference call
Subscribe for More Information
September 17, 2014
07:43 EDTBMRNBofA/Merrill to hold a conference
Subscribe for More Information
September 16, 2014
09:00 EDTCPRXCatalyst Pharmaceutical price target raised to $5 from $3.50 at Roth Capital
Roth Capital increased its price target on Catalyst to reflect what it sees as greater pricing power opportunities for Firdapse and the re-entry of CPP-115 into the clinic. Evaluating the potential outcome of a Phase 3 trial of Firdapse expected at the end of this month, the firm says the decision by all patients enrolled to continue treatment in the 2-year open label part of the trial is positive. However, Roth warns that the data poses a binary risk to the stock. It keeps a Buy rating on the shares. .
September 15, 2014
08:32 EDTCPRXCatalyst Pharmaceutical price target raised to $13 from $5 at H.C. Wainwright
Subscribe for More Information
September 8, 2014
07:15 EDTBMRNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.

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

I agree to the theflyonthewall.com disclaimer & terms of use