CPRX $2.86 in some here. Many catalysts upcoming. Insider buying by CEO at $2.99 on January 13th and more insider buying by others. Check the filings.
Anticipated 2015 Goals
Catalyst expects to achieve the following key milestones in the upcoming year:
Conduct Pre-NDA meeting. Catalyst expects to hold a pre-NDA meeting with the FDA in Q1 2015.
Submit Firdapse™ NDA to FDA. Catalyst expects to complete its renal safety study and full toxicology program for Firdapse™ in Q2 2015, with an anticipated completion of an NDA submission to the FDA by Q3 2015.
Complete launch of Firdapse™ expanded access program. Catalyst is currently enrolling LEMS and CMS patients in the expanded access program, which will provide Firdapse™ at no charge to patients who meet the inclusion/exclusion requirements.
Complete all pre-commercialization activities required for successful Firdapse™ launch. The Company will continue to focus on pre-commercial activities ahead of an estimated approval / launch of Firdapse™ in 1H 2016.
CPP-109: Top-line results from Tourette's Disorder. An academic investigator sponsored study evaluating CPP-109 for the treatment of Tourette's Disorder is ongoing at Mt. Sinai, in New York, and Catalysts expects to announce topline results in the first half of 2015.
CPP-115: Catalyst expects to announce topline results from a Phase 1 multiple dose safety and tolerance study in the first half of 2015.
Exploration of additional indications for Firdapse™. Catalyst plans to continue to explore additional indications including Congenital Myasthenic Syndrome and refractory Myasthenia Gravis.
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