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January 7, 2014
08:14 EDTCPRXCatalyst Pharmaceutical announces dismissal of stockholder class action lawsuit
Catalyst Pharmaceutical announced that on January 3, the previously reported stockholder class action lawsuit that had been filed against Catalyst and certain of its officers and directors was dismissed without prejudice. In the Court's order, the plaintiffs were granted leave to file an amended complaint within 20 days. Catalyst has no information as to whether any such amended complaint is planned by the plaintiffs. If an amended complaint is filed in the case, Catalyst intends to vigorously defend the amended lawsuit.
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July 22, 2015
13:26 EDTCPRXCatalyst Pharmaceutical initiates rolling NDA submission for Firdapse
Catalyst Pharmaceuticals announced the initiation of a rolling submission of a New Drug Application to the U.S. FDA for Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome. Firdapse has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS, as well as orphan drug designations for LEMS and congenital myasthenic syndromes. The company said, “We expect to complete the submission of the NDA in the fourth quarter of 2015, at which time we will be requesting a Priority Review of our application. We will continue to work closely with the FDA as we seek approval of the NDA."

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