Targeted Strategies for Today's Evolving Markets

MissionIR Blog

Catalyst Pharmaceuticals, Inc. (CPRX) Rapidly Approaching Commercialization of Firdapse®

Catalyst Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative therapies for people with rare debilitating diseases. The company’s lead product candidate, Firdapse®, recently completed a pivotal phase III clinical trial for the treatment of Lambert-Eaton myasthenic symdrome (LEMS), a rare neuromuscular, autoimmune disorder that afflicts about 3,000 people in the United States. Catalyst took a significant step toward the eventual commercialization of its innovative candidate when it initiated submission of a rolling new drug application (NDA) to the U.S. Food and Drug Administration (FDA) earlier this year. The company anticipates completing this submission during the fourth quarter, putting it on schedule for approval in the first half of 2016.

“[W]e have been working diligently to advance regulatory and commercial affairs and are pleased with the initiation of our rolling NDA submission to the FDA for Firdapse,” Patrick J. McEnany, chief executive officer of Catalyst, stated in a news release. “Additionally, we are on schedule with our key commercial strategic imperatives to support the successful launch of Firdapse.”

Catalyst’s development pipeline also includes CPP-115, which is being studied for the treatment of infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, such as post-traumatic stress disorder and Tourette’s disease. CPP-115 has been granted U.S. orphan drug designation by the FDA for the treatment of infantile spasms, making it eligible for a host of incentives designed to limit the costs associated with future development efforts.

In February, the company completed an offering of common stock that raised net proceeds of approximately $34.9 million to help fund its promising development programs. As of June 30, Catalyst reported cash and cash equivalents of $67.4 million with no outstanding debt. These considerable resources are expected to fund the company’s ongoing operations through the anticipated approval and subsequent product launch of Firdapse in 2016.

As it approaches the commercial launch of Firdapse, Catalyst is in a favorable position to promote strong financial growth. Look for the company to benefit from the operational flexibility afforded by its strong balance sheet as it focuses on making significant progress with the ongoing development of its product pipeline.

For more information, visit

This entry was posted in Small Cap News. Bookmark the permalink.

Comments are closed.