Welcome to our dedicated page for Catalyst Pharmaceutical news (Ticker: CPRX), a resource for investors and traders seeking the latest updates and insights on Catalyst Pharmaceutical stock.
Catalyst Pharmaceuticals Inc. (CPRX) is a pioneering biopharmaceutical company dedicated to developing and commercializing innovative therapies for rare and debilitating diseases. The company's primary focus lies in addressing chronic neuromuscular and neurological conditions that severely impact patients' lives. Among its core areas are Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette's disorder.
Firdapse®, Catalyst's lead candidate, is a proprietary form of amifampridine phosphate designed for the treatment of patients with LEMS. This drug has successfully completed a global, multi-center, double-blinded randomized pivotal Phase 3 trial, yielding positive top-line data. Following these promising results, Catalyst submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking approval for the treatment of both LEMS and CMS. Notably, Firdapse® has received breakthrough therapy designation and orphan drug designation from the FDA for these conditions. Additionally, Firdapse® stands as the first and only European-approved drug for symptomatic treatment in adults with LEMS.
Catalyst Pharmaceuticals is also advancing CPP-115, a promising candidate for the treatment of infantile spasms, epilepsy, and other neurological conditions. This initiative underscores the company's commitment to addressing unmet medical needs within the realm of rare diseases.
The company boasts a solid financial foundation, enabling sustained investment in research and development, as well as strategic partnerships to enhance its product pipeline. Catalyst's innovative approach and dedication to improving patients' lives make it a significant player in the biopharmaceutical industry.
Latest News:
- Santhera's study reports the results of the 48-week treatment with Vamorolone in patients with Duchenne Muscular Dystrophy (DMD), supporting the long-term efficacy and safety profile of Vamorolone. (Reference: Neurology 2024;102:e208112)
- Financial highlights and recent business updates, including the 2024 outlook and details about an upcoming conference call and webcast on February 29, 2024.
Catalyst Pharmaceuticals (CPRX) is set to release its Q1 2023 financial results after market close on May 10, 2023. A conference call and webcast discussing the results will take place on May 11, 2023, at 8:30 AM ET. The company specializes in developing innovative medicines for rare diseases, with its key product being FIRDAPSE for Lambert-Eaton myasthenic syndrome. Additionally, Catalyst recently acquired U.S. commercial rights to FYCOMPA, an epilepsy treatment approved for patients aged four and older. The company highlights its commitment to patient care and innovative solutions in the biopharmaceutical sector. Investors can access the webcast via their official website, where a replay will be available for 30 days.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the upcoming presentation of four abstracts related to FYCOMPA (perampanel) at the AAN 2023 Annual Meeting in Boston, MA, from April 22-27, 2023. These studies, presented by Eisai, detail the efficacy of FYCOMPA in treating various types of seizures in patients aged four and older, including those with psychiatric histories and Lennox-Gastaut Syndrome. Catalyst's Chief Medical Officer, Gary Ingenito, emphasized the importance of these findings in enhancing understanding of perampanel's therapeutic benefits. FYCOMPA is indicated for partial-onset seizures and primary generalized tonic-clonic seizures. It is available in multiple dosages and is prescribed globally to over 500,000 patients.
Catalyst Pharmaceuticals (CPRX) reported record total net revenues of $214 million for 2022, marking a 52% year-over-year increase. FIRDAPSE® alone contributed $61 million in Q4 2022, up 59% from the previous year. The recent acquisition of FYCOMPA® is projected to enhance EBITDA and EPS in 2023, with total net product revenue guidance between $375 million and $385 million. The company ended 2022 with $298 million in cash, poised for further product portfolio diversification and expansion. Catalyst has strengthened its patent portfolio and continues to drive strategic initiatives, demonstrating strong financial performance and growth potential.
Catalyst Pharmaceuticals announced positive findings regarding FYCOMPA® (perampanel) for treating rare genetic epileptic diseases. An article in Epilepsia reported that 43.5% of 137 patients experienced over a 75% reduction in seizure frequency, with 27.5% achieving over a 90% reduction. This high efficacy was noted among various genetic mutations such as SCN1A and GNAO1. Dr. Gary Ingenito emphasized the potential of FYCOMPA® in managing these challenging conditions. Additionally, Catalyst acquired the U.S. rights to FYCOMPA® in January 2023, expanding its portfolio, which includes FIRDAPSE® for Lambert-Eaton myasthenic syndrome.
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