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.
July 23, 2014
08:10 EDTBMRNBioMarin, Sarah Cannon Research UK collaborate on EMBRACA clinical study
BioMarin Pharmaceutical and Sarah Cannon Research UK announced a collaboration to enroll patients in an ongoing Phase 3 clinical trial of its PARP inhibitor, BMN 673, for the treatment of hereditary breast cancer with a BRCA mutation. This ongoing Phase 3 trial has recently been named EMBRACA. Sarah Cannon Research UK enrolled the first patient outside of the United States, expanding the trial internationally.
07:44 EDTBMRNBioMarin survey shows strong Vimizim demand, says Leerink
Subscribe for More Information
July 16, 2014
09:02 EDTCPRXSummer Street chief scientific officer holds an analyst/industry conference call
Subscribe for More Information
July 15, 2014
10:56 EDTBMRNFed calls small cap social media, biotech valuations 'stretched'
The Board of Governors of the Federal Reserve in its Monetary Policy Report dated today said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year." A later part in the document reads, "Equity valuations of smaller firms as well as social media and biotechnology firms appear to be stretched, with ratios of prices to forward earnings remaining high relative to historical norms." The specific targeting of sectors by the Fed seems to be having an impact on stocks in the social media and biotech spaces. Shares of Yelp (YELP) are down over 5% to $67.51, while Twitter (TWTR) and Facebook (FB) are each down 2%. Celgene (CELG) and Amgen (AMGN) are leading the biotech space lower with pullbacks of greater than 1%.

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