- Catalyst Pharmaceuticals (NASDAQ:CPRX) is up 3% premarket on light volume in response to its announcement that a second Phase 3 study, LMS-003, assessing Breakthrough Therapy-tagged Firdapse (amifampridine phosphate tablets) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) met its two co-primary endpoints.
- LEMS is an autoimmune disorder characterized by muscle weakness in the arms and legs caused by the buildup of antibodies at the connection between nerve and muscle (neuromuscular junction). It commonly strikes people over the age of 40 and is prevalent in those with lung cancer.
- The results will be submitted for presentation at future medical conferences and for publication.
- The company expects to file a U.S. marketing application next quarter.
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- The company conducted the second study at the request the FDA.
- Amifampridine enhances neuromuscular transmission by blocking the potassium channel. This causes depolarization of the presynaptic membranes which opens the calcium channel thereby enabling muscle fibers to contract.
- Previously: Catalyst Pharma down 48% after FDA says new Phase 3 study needed for Firdapse NDA (April 26, 2016)
- Previously: FDA rejects Catalyst Pharma's Firdapse NDA; shares slump 38% (Feb. 17, 2016)
- Now read: Supernus: Market Overreacts After Interim Analysis Of SPN-810 Phase 3 Trial
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