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 www.catalystpharma.com
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