CORAL GABLES, Fla. - Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX), a pharmaceutical company demonstrating excellent financial health according to InvestingPro metrics, announced today that its Japanese sub-licensee, DyDo Pharma, Inc., has launched FIRDAPSE® (amifampridine) Tablets 10 mg in Japan. The medication is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that causes muscle weakness and fatigue.
FIRDAPSE® is currently the only U.S. FDA-approved therapy for LEMS in adults and pediatric patients six years of age and older. The launch in Japan is part of Catalyst's mission to expand patient access to its portfolio of novel treatments for rare diseases globally.
Richard J. Daly, Catalyst’s President and CEO, expressed satisfaction with the launch, citing it as a step forward in the company's commitment to health equity and expanding the reach of its products. He stated that the introduction of FIRDAPSE® in Japan would provide healthcare providers and patients with a new therapy option.
The medication works by blocking potassium channels, which leads to the opening of calcium channels. This results in increased release of acetylcholine, a neurotransmitter essential for muscle function. FIRDAPSE® has been granted orphan drug designation by the Ministry of Health, Labor, and Welfare in Japan and is also approved for use in the United States, Europe, and Canada.
DyDo Pharma, a subsidiary of DyDo Group Holdings, specializes in pharmaceuticals for rare diseases. The parent company, founded in 1975 and based in Osaka, Japan, operates in various segments including beverages and food, with a significant portion of its sales coming from the domestic beverage business.
Catalyst Pharmaceuticals is based in Coral Gables, FL, and was recognized on the 2024 Deloitte Technology Fast 500™ List for rapid growth in North America. The company has a strong U.S. presence and is actively seeking opportunities to grow its commercial footprint through strategic global partnerships.
This news is based on a press release statement from Catalyst Pharmaceuticals. The company's forward-looking statements indicate that future results may differ due to various risks and uncertainties, including the commercial success of FIRDAPSE® in Japan and the materiality of future revenues from the sub-license with DyDo to Catalyst's earnings.
In other recent news, Catalyst Pharmaceutical (TADAWUL:2070) Partners has seen significant developments in its financial performance. The company reported an impressive 25.3% increase in Q3 2024 revenues, driven by robust sales of FIRDAPSE and AGAMREE. Catalyst also revised its full-year revenue guidance upwards to between $475 million and $485 million, reflecting confidence in sustained product demand. This follows a recent settlement with TEVA over the marketing of a generic version of Firdapse, which has secured the drug's market protection until February 2035.
Analysts from Oppenheimer, BofA Securities, and Citi have maintained positive ratings on Catalyst, with price targets ranging from $29 to $31. These ratings are backed by the company's strong financial health, including zero debt and strong liquidity metrics. Recent developments suggest that Catalyst Pharmaceutical Partners is poised for continued growth, especially with the extended market exclusivity of Firdapse and the anticipated increase in investor interest.
However, it's important to note that these are recent developments and the situation may change based on a variety of factors. As always, investors are encouraged to conduct their own due diligence before making any investment decisions.
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