Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) reported positive top-line data from a second Phase III clinical study – LMS-003 of Firdapse® for the symptomatic cure of Lambert-Eaton myasthenic syndrome. Firdapse obtained Breakthrough Therapy status from the FDA in 2013 and this clinical study was performed utilizing a protocol permited to by the FDA via the Special Protocol Assessment process. This study recorded two prospectively stated co-primary endpoints.
Data from the LMS-003 study continue to showcase that amifampridine phosphate has a considerable magnitude of effect in curing the indications of LEMS patients. Perry Shieh, MD, PhD, the Principal Investigator of the clinical study, reported that the report is particularly meaningful considering the need for FDA-permitted therapies which may change the lives of people suffering from LEMS.
Patrick J. McEnany, the CEO and President of Catalyst Pharmaceuticals, reported that they are extremely delighted with the top-line safety and efficacy data from this second Phase III study, which reinforces the prospect of Firdapse to be a vital treatment for people suffering from LEMS. They look forward to showcasing further data in upcoming publications and at medical conferences. The management remain on track to file their NDA to the U.S. FDA in Q1 2018. Catalyst continues to remain committed to the advancement of therapies that will enhance the lives and function of people with rare neurodegenerative ailments.
Gary Ingenito, MD, Ph.D., the Chief Medical Officer of Catalyst, reported that the company has once again demonstrated that Firdapse is able to exhibit a positive, clinically substantial effect in the symptomatic cure of LEMS. They thank all those folks who participated in this LMS-003 study, in order to have the probability of an FDA approved drug accessible to the people suffering from LEMS.
In the last trading session, the stock price of Catalyst gained more than 3% to close the day at $4.02. The gains came at a share volume of 1.10 million compared to average share volume of 1.02 million.