Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) announced that the first patient has been enrolled into its second Phase 3 clinical trial (designated as LMS-003) to evaluate the efficacy and safety of Firdapse® (amifampridine phosphate) in patients with Lambert-Eaton myasthenic syndrome (LEMS).
In October 2016, Catalyst announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach in this additional Phase 3 trial. Catalyst has previously announced positive results from its first Phase 3 clinical trial evaluating Firdapse for the treatment of LEMS.
“The initiation of our second Phase 3 study of Firdapse in LEMS patients is a significant step forward on our path towards gaining approval for Firdapse,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “We believe we have a clearly defined development and regulatory pathway for Firdapse in the treatment of LEMS and remain focused on our goal of improving access to treatments for patients with this significant unmet need.”
“Based on the positive results seen in our previous Phase 3 study, we look forward to continuing to investigate Firdapse for the treatment of LEMS,” said Gary Ingenito, M.D., Ph.D., Chief Medical Officer of Catalyst. “We are grateful to the patients and families, as well as their physicians, who have participated in our expanded access program and are participating in this second Phase 3 study.” (Original Source)
Shares of Catalyst Pharmaceutical are currently trading flat at $1.17. CPRX has a 1-year high of $3 and a 1-year low of $0.51. The stock’s 50-day moving average is $1.09 and its 200-day moving average is $0.96.
On the ratings front, CPRX has been the subject of a number of recent research reports. In a report issued on November 14, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on CPRX. Separately, on November 10, Roth Capital’s Scott Henry reiterated a Buy rating on the stock and has a price target of $2.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Scott Henry have a yearly average return of 1.3% and a loss of -2.2% respectively. Fein has a success rate of 40% and is ranked #1710 out of 4274 analysts, while Henry has a success rate of 36% and is ranked #3731.
Catalyst Pharmaceuticals, Inc. is a biopharmaceutical company. It focuses on development and commercialization of prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette’s disorder.