NEW YORK (AP) -- Shares of Catalyst Pharmaceutical Partners advanced Tuesday after the company said it will get FDA assistance in developing its drug Firdapse.
THE SPARK: Catalyst said the Food and Drug designated Firdapse as a breakthrough therapy for a rare autoimmune disease that causes muscle weakness. The designation is given to drugs that could be a significant improvement in treatment for a life-threatening disease or condition. The FDA will give Catalyst additional guidance and advice during clinical development, and Catalyst can submit data as it complies it, which could speed up the review process.
THE BIG PICTURE: The Coral Gables, Fla., company wants to market Firdapse as a treatment for Lambert-Eaton Myasthenic Syndrome, or LEMS. The primary symptom of LEMS is muscle weakness. That weakness is usually worst in the muscles of the legs and trunk, and Catalyst said the condition can be life-threatening when respiratory muscles are weakened. It said there are about 3,000 patients in the U.S. and Canada, and about half of all patients have small cell lung cancer.
Catalyst said there are no approved or effective treatments for the symptoms of LEMS.
Firdapse was developed by BioMarin Pharmaceuticals Inc., and it is approved in the European Union. BioMarin licensed the drug to Catalyst in October.
Catalyst does not have any approved drugs. It is studying potential treatments for infantile spasms, seizures, and Tourette syndrome.
SHARE ACTION: Shares of Catalyst Pharmaceutical Partners Inc. climbed 57 cents, or 40.1 percent, to $1.99 in afternoon trading. Earlier the stock reached a three-year high of $2.50.