Catalyst Pharmaceuticals Inc (Catalyst) is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare and difficult-to-treat diseases. The company's product portfolio includes Firdapse (amifampridine) tablets, Fycompa (perampanel) tablets and oral suspension, and Agamree (vamorolone) oral suspension.

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Catalyst is actively engaged in research and development initiatives aimed at expanding its product portfolio and enhancing its offerings for rare and difficult-to-treat diseases. The company's R&D strategy includes several key initiatives: the development and commercialization of AGAMREE for the treatment of Duchenne muscular dystrophy (DMD) and exploring additional indications for the product. A Phase 1 trial is being conducted to evaluate AGAMREE against other steroids, assessing dose equivalence and the immunosuppressive dose. The SUMMIT registry study is gathering real-world data on the benefits of AGAMREE over other corticosteroids. The Catalyst Pathways Program is a personalized treatment support program designed to ensure patient access to AGAMREE or FIRDAPSE, including patient assistance and financial support initiatives. The company is also pursuing an acquisition and licensing strategy to broaden and diversify its product portfolio, targeting immediate or near-term accretive acquisitions, particularly in rare disease therapeutic categories. Additionally, Catalyst continues to commercialize FIRDAPSE for Lambert-Eaton myasthenic syndrome (LEMS) and plans to evaluate it for other conditions. The company acquired the US rights to FYCOMPA and is focusing on maintaining its market presence amidst generic competition. Overall, Catalyst Pharmaceuticals is committed to expanding its R&D efforts and product offerings through strategic acquisitions, collaborations, and the development of innovative therapies for rare diseases. In FY2025, the company incurred expenses of US$12.7 million on R&D, which as a percentage of revenue, stood at 2.2%.