Catalyst Pharmaceuticals Inc (NASDAQ:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a confirmatory Phase 3 study protocol for Firdapse® (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). As part of the clinical protocol for the confirmatory study, Catalyst expects to initiate a small, single-center study with Firdapse during the second half of 2016. Catalyst also expects to announce additional information about the study design and timelines for the study once they are finalized.
“We are pleased to have the FDA’s agreement on the design of the protocol for our second Phase 3 trial evaluating Firdapse for the treatment of LEMS. This is an important milestone in our effort to provide all LEMS patients with access to an FDA approved therapy,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “Additionally, we have recently completed an analysis of our cash forecasts and budgets under our reorganized operational plan and believe, based on currently available information, that our existing capital resources are adequate to get us to an accepted NDA submission without the need for additional financing.” (Original Source)
Shares of Catalyst Pharmaceutical are up 29% to $0.80 in pre-market trading. CPRX has a 1-year high of $5.80 and a 1-year low of $0.51. The stock’s 50-day moving average is $0.64 and its 200-day moving average is $1.45.
On the ratings front, CPRX has been the subject of a number of recent research reports. In a report issued on April 26, Piper Jaffray analyst Charles Duncan downgraded CPRX to Hold, with a price target of $1, which represents a potential upside of 61.3% from where the stock is currently trading. Separately, on March 22, Roth Capital’s Scott Henry reiterated a Buy rating on the stock and has a price target of $3.25.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Charles Duncan and Scott Henry have a total average return of -5.6% and -0.7% respectively. Duncan has a success rate of 41.8% and is ranked #3622 out of 3892 analysts, while Henry has a success rate of 36% and is ranked #2860.
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. The company was founded by McEnany J. Patrick and Huckel E. Hubert in January 2002 and is headquartered in Coral Gables, FL.