Catalyst catapults on FDA 'breakthrough' for rare autoimmune disease drug
This article was originally published in Scrip
Shares of Catalyst Pharmaceutical Partners catapulted 76% on 27 August on news the FDA granted breakthrough therapy designation to the Florida specialty pharma's experimental drug Firdapse (amifampridine phosphate), which is under investigation to treat symptoms associated with Lambert-Eaton Myasthenic syndrome (LEMS), a rare autoimmune disease, which results in muscle weakness, particularly in the legs and trunk.
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Catalyst executives note that the company has completed everything the FDA requested to support resubmission of Firdapse for its first two rare disease indications – a second Phase III study in LEMS and abuse liability studies.
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