Catyalyst Pharma (NASDAQ: CPRX) reported Q4 EPS of ($0.05), $0.02 better than the analyst estimate of ($0.07). Revenue for the quarter came in at $-4.27M.

2016 and Recent Highlights

• Began enrolling patients into second Phase 3 clinical trial to evaluate the efficacy and safety of Firdapse in patients with Lambert-Eaton Myasthenic Syndrome (LEMS)
• Reached an agreement with the FDA under a SPA for the protocol design, clinical endpoints, and statistical analysis approach to be taken in our second Phase 3 study evaluating Firdapse for LEMS
• Expanded Congenital Myasthenic Syndromes (CMS) trial with Firdapse beyond pediatric patients to include adult CMS patients and increased enrollment size
• Case report published on the efficacy of CPP-115 in a child with refractory infantile spasms in Epilepsy & Behavior Case Reports
• Continued to augment enrollment in the Firdapse expanded access program (EAP)
• Firdapse granted Orphan Drug Designation for the treatment of myasthenia gravis
• Ended 2016 with $40.4 million in cash and investments and no debt

Upcoming Milestones

• Complete enrollment in LEMS (LMS-003) and CMS (CMS-001) clinical trials
• Expect top-line results from LEMS and CMS trials; and NDA submission for Firdapse in second-half 2017
• Begin discussions with FDA and external experts about regulatory path forward for the MuSK-MG pivotal, U.S. multi-center trial
• Exploring alternatives for CPP-115 further development
• Ongoing development of generic equivalent of Sabril® (vigabatrin)
• In the second half of 2017 reinitiate pre-commercialization activities for a potential 2018 launch of Firdapse

For earnings history and earnings-related data on Catyalyst Pharma (CPRX) click here.