Amifampridine phosphate

Plus, news about Nykode, Therna Biosciences, Fosun, Sitala Bio, Catalyst Pharmaceuticals and Lupin: 🔎 Lilly’s Verzenio improves survival in early breast cancer: In the seven-year analysis of the monarchE trial, two years of treatment with Verzenio on top of endocrine therapy as an adjuvant therapy improved survival compared to endocrine therapy alone. The massive study enrolled over 5,000 patients with HR+, HER2-, node-positive early breast cancer at high risk of recurrence. Lilly kept details under wraps, saying the data will be shared at a future medical meeting. Verzenio was first approved in this indication in 2021 with an expanded label in 2023. — Lei Lei Wu 📝 RemeGen gets another Phase 3 win: This time, the Chinese biotech’s drug telitacicept succeeded in an IgA nephropathy trial, and it plans to ask Chinese drug authorities for approval. In the Phase 3 study, telitacicept cut a kidney function measure known as 24-hour UPCR by 55% at 9 months compared to placebo. The news was announced by its Cambridge-based partner Vor Bio, which holds rights to the drug outside China, Hong Kong, Macau and Taiwan. Vor Bio’s shares $VOR fell 3% Wednesday morning. Earlier in August, RemeGen’s drug also passed a Sjögren’s study . If approved, the Sjögren’s indication would mark telitacicept’s fourth indication, while IgA nephropathy would be its fifth in China. — Lei Lei Wu 🔭 Nykode seeks to re-partner cancer vaccine: The Oslo-based biotech said that it’s seeking to attract potential partners for its individualized neoantigen cancer vaccine VB10.NEO, and will make a limited investment in the program moving forward. Genentech dropped its deal with Nykode over the experimental cancer vaccine at the start of this year. — Lei Lei Wu 💰 Therna Biosciences lands $10M: The RNA medicines startup emerged with a seed round from AIX Ventures, Pear VC and Fusion Fund to work on an AI-driven platform. It was founded by UCSF and Arc Institute investigator Hani Goodarzi. San Francisco-based Therna is led by co-founder and CEO Nazli Azimi, who previously founded Bioniz Therapeutics. — Kyle LaHucik 🤝 Fosun does another Western deal: The Shanghai biotech is licensing an inflammatory disease drug candidate to Sitala Bio. The UK biotech is backed by Forbion and OrbiMed, according to the websites of the investors. Fierce Biotech reported on the deal on Tuesday, noting it’s worth up to $670 million. Fosun did a lung disease licensing deal with Expedition Therapeutics earlier this month. — Kyle LaHucik 🖊️ Catalyst Pharmaceuticals settles patent dispute with Lupin: The US biotech has inked an agreement with India’s Lupin over a generic version of Catalyst’s treatment, called Firdapse, for Lambert-Eaton myasthenic syndrome. Under the terms of the settlement, Lupin can’t market its generic drug until Feb. 25, 2035. Catalyst reached a similar agreement with Teva in January. — Ayisha Sharma

As Part of the Settlement, Lupin Receives a License to Market Generic FIRDAPSE Beginning in February 2035 As Part of the Settlement, Lupin Receives a License to Market Generic FIRDAPSE Beginning in February 2035 CORAL GABLES, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the Company and its licensor SERB S.A. (“SERB”) have entered into a Settlement Agreement (“Agreement”) with Lupin Ltd and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Lupin’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of FIRDAPSE® (amifampridine) 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Lupin will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, if approved by the U.S. Food and Drug Administration, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing patent litigation between Catalyst/SERB and Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. The pending FIRDAPSE patent litigation against the remaining defendant, Hetero, regarding FIRDAPSE’s Orange Book-listed patents is 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. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies. For more information, please visit Catalyst's website at www.catalystpharma.com. Forward-Looking Statements This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the ongoing litigation matters referenced above between Catalyst/SERB and Hetero with respect to FIRDAPSE®’s Orange Book listed patents will allow a generic version of FIRDAPSE to be marketed in the U.S. prior to February 25, 2035, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2024, its Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2025, and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Source: Catalyst Pharmaceuticals, Inc. Source: Catalyst Pharmaceuticals, Inc.