Catalyst Pharmaceuticals is a development stage biopharmaceutical company which is developing CPP-115 to treat reduced GABAergic signaling-associated neurological conditions, such as Tourette’s and post-traumatic stress disorder. The FDA has designated CPP-115 orphan drug status in the U.S. for the treatment of infantile spasms. In Europe, for the treatment of West syndrome, it has been granted E.U. orphan medicinal product designation. In addition, the company is also developing a generic version of Sabril® (vigabatrin).
This prospectus offering is part of the company’s Shelf Registration Statement declared effective by the SEC on March 19, 2014. That enabled it to periodically sell its stock shares in the aggregate of $33,842,512, Catalyst Pharmaceuticals said in the new prospectus filing.
The company originally had 150 million shares of common stock and five million shares of preferred. Currently, it has 82,972,316 shares of common outstanding and no preferred shares outstanding.
The company expects to report to the FDA top line results in the second half of 2017 for its second phase 3 trial evaluating its candidate drug Firdapse® for the treatment of Lambert-Eaton Myasthenic Syndromes (LEMS). If the results are successful, the company expects to resubmit an NDA for Firdapse for the treatment of LEMS.
Further, if those test results are successful, the company expects to additionally provide evidence that Firdapse treats certain types of Congenital Myasthenic Syndromes (CMS) and request that CMS be included in its initial label.
Catalyst Pharmaceuticals, Inc., may also evaluate that drug for the treatment of myasthenia gravis and other rare neuromuscular diseases. No clinical programs for these indications have yet been developed, the company stated in the prospectus.
For CPP-115, the company intends to develop the drug for the treatment of epilepsy and Tourette’s syndrome. It would perform the required studies, subject to funding availability.
For more information, visit www.CatalystPharma.com
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