Shares of Catalyst Pharmaceuticals (NASDAQ: CPRX) are up more than 40% this morning following the company’s release of positive top-line results from the investigator-sponsored trial evaluating Firdapse® as a treatment for myasthenia gravis (MG) patients with anti-MuSK antibodies (MuSK-MG). MuSK-MG is an extremely rare form of MG with no FDA approved therapies currently available. Both of the co-primary efficacy endpoints of change from baseline (CFB) in total quantitative myasthenia gravis score and CFB in total myasthenia gravis activities of daily living score were statistically and clinically significant in this trial. Several secondary efficacy measures also achieved statistical significance, and the drug was well tolerated in patients. “These data announced today should allow us to accelerate our MuSK-MG program over the coming months, as we expect to consult with our external experts and regulatory agencies on a pivotal clinical development plan,” Catalyst CEO Patrick J. McEnany stated in the news release.
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About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK myasthenia gravis and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS. Catalyst is also developing CPP-115 to treat refractory infantile spasms and possibly refractory Tourette’s Disorder. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin). For more information, visit www.catalystpharma.com.
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