ARTICLE | Company News

Catalyst receives breakthrough designation for Firdapse

August 27, 2013 11:55 PM UTC

Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX) gained $0.59 (42%) to $2.01 on Tuesday after FDA granted breakthrough therapy designation to Firdapse amifampridine to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder characterized by muscle weakness caused by impaired presynaptic release of acetylcholine. The potassium channel blocker is in Phase III testing in the U.S., with data expected in 2Q14 and an NDA submission planned for late 2014 or early 2015. Firdapse is already approved for LEMS in the EU. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), which granted Catalyst exclusive, North American rights to Firdapse last year, was down $1.45 to $64.18 on Tuesday. ...