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CORAL GABLES, Fla. - Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX), a $2.58 billion market cap biopharmaceutical company with an impressive 83% gross profit margin, announced Monday it has reached a settlement agreement with Lupin Ltd and Lupin Pharmaceuticals to resolve patent litigation over FIRDAPSE, a treatment for rare diseases. According to InvestingPro analysis, the company appears undervalued based on its Fair Value estimates.
Under the agreement, Lupin will not market its generic version of FIRDAPSE (amifampridine) 10 mg tablets in the United States before February 25, 2035, if approved by the FDA, unless certain limited circumstances occur. The settlement ends all ongoing patent litigation between the parties regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey.
Catalyst and its licensor SERB S.A. had initiated the litigation in response to Lupin’s Abbreviated New Drug Application seeking approval to market a generic version of FIRDAPSE before the expiration of applicable patents.
This marks Catalyst’s third settlement regarding ANDA applications for FIRDAPSE, following previous agreements with Teva Pharmaceuticals and Inventia Life Science. Patent litigation against the remaining defendant, Hetero, is still ongoing.
As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients with rare and difficult-to-treat diseases, according to the press release statement.
In other recent news, Catalyst Pharmaceuticals reported its Q2 2025 earnings, delivering a notable performance that exceeded analysts’ expectations. The company achieved an earnings per share (EPS) of $0.68, significantly higher than the forecasted $0.39, marking a 74.36% surprise. Additionally, Catalyst Pharmaceuticals reported revenue of $146.54 million, surpassing the anticipated $140.22 million. These results highlight a strong quarter for the company in terms of financial performance. Despite the positive earnings and revenue results, the stock experienced a decline in the latest trading session. Analysts and investors are likely to take note of these financial outcomes as they evaluate the company’s future prospects. The earnings report underscores Catalyst Pharmaceuticals’ ability to outperform market expectations.
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