New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 6, 2014
08:15 EDTCPRXCatalyst reports successful completion of Type B therapy meeting with FDA
Catalyst Pharmaceutical announced the successful completion of a Type B meeting with the FDA about Firdapse tablets, its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome, or LEMS. Catalyst provided FDA with an update on the development program for Firdapse, which received Breakthrough Therapy designation from the FDA in August 2013. The company also confirmed with FDA the clinical, nonclinical, and chemistry and manufacturing controls requirements that FDA will require to approve a New Drug Application for Firdapse. This Type B meeting with the FDA was Catalyst's first meeting as the sponsor of the IND for Firdapse. Catalyst will file rolling submissions of the NDA modules as completed in anticipation of receiving a priority review of its NDA for Firdapse. The Company provided a briefing package to the FDA that described all completed, in-progress, and planned preclinical studies, clinical studies, and drug manufacturing activities. This package included summaries of 54 preclinical studies, six clinical studies, and information related to drug manufacturing. The FDA concurred that the Company's completed, in-progress, and planned development activities represented a nearly complete package of information that would be needed for a complete NDA.
News For CPRX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
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
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 24, 2015
10:00 EDTCPRXOn The Fly: Analyst Initiation Summary
Subscribe for More Information
09:22 EDTCPRXCatalyst Pharmaceutical initiated with a Buy at MLV & Co.
Target $14.
09:10 EDTCPRXOn The Fly: Pre-market Movers
Subscribe for More Information
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.

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