Catalyst Pharma Announces Third Quarter 2016 Financial Results And Provides Corporate Update
CORAL GABLES, Fla., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today reported financial results for the third quarter and nine months ended September 30, 2016 and provided a corporate update.
Patrick J. McEnany, Chief Executive Officer of Catalyst stated: "Over the last few months, we have continued to execute our development strategy for Firdapse® (amifampridine phosphate) and further our mission to serve the LEMS and CMS patient communities. We were pleased by our recent receipt of a Special Protocol Assessment agreement with the FDA for the protocol design, clinical endpoints, and statistical analysis approach to be taken in our upcoming, second Phase 3 study evaluating Firdapse for the symptomatic treatment of LEMS. We believe that our receipt of the SPA provides us with a clearly defined development and regulatory pathway to complete the development of this product. We were also gratified to have been granted orphan drug designation for Firdapse for the treatment of myasthenia gravis. Finally, we have launched our new website to make it easier for patients to access information about obtaining Firdapse at no cost through our expanded access program, which is another step in our continuing efforts to serve LEMS and CMS patients.”
Patrick J. McEnany, Chief Executive Officer of Catalyst stated: "Over the last few months, we have continued to execute our development strategy for Firdapse® (amifampridine phosphate) and further our mission to serve the LEMS and CMS patient communities. We were pleased by our recent receipt of a Special Protocol Assessment agreement with the FDA for the protocol design, clinical endpoints, and statistical analysis approach to be taken in our upcoming, second Phase 3 study evaluating Firdapse for the symptomatic treatment of LEMS. We believe that our receipt of the SPA provides us with a clearly defined development and regulatory pathway to complete the development of this product. We were also gratified to have been granted orphan drug designation for Firdapse for the treatment of myasthenia gravis. Finally, we have launched our new website to make it easier for patients to access information about obtaining Firdapse at no cost through our expanded access program, which is another step in our continuing efforts to serve LEMS and CMS patients.”