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 (Nasdaq: CPRX) has announced the acquisition of U.S. rights to FYCOMPA® (perampanel) from Eisai Co., Ltd for $160 million. This acquisition enhances Catalyst's commercial portfolio and strengthens its presence in the neurology market, particularly in the treatment of epilepsy. The addition of FYCOMPA, projected to generate approximately $136 million in net revenues for the fiscal year ending March 31, 2023, is expected to be accretive to EBITDA and EPS in 2023. The company anticipates leveraging synergies with its existing product, FIRDAPSE®, to drive organic growth.
Catalyst Pharmaceuticals (NASDAQ: CPRX) announced today that it received notice from an ANDA filer regarding a generic version of FIRDAPSE®. Teva Pharmaceuticals seeks FDA authorization to manufacture and sell this generic drug. Catalyst noted that while the FDA complies with the 11th Circuit's decision favorable to the company regarding FIRDAPSE®, the agency will continue to enforce regulations on orphan drug exclusivity. Catalyst is not affected by this new FDA position and plans to vigorously protect its intellectual property rights related to FIRDAPSE®. The FDA approved Catalyst's application expanding FIRDAPSE® label for children aged 6-17 in September 2022.
Catalyst Pharmaceuticals (NASDAQ: CPRX) announced it received a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals, which seeks FDA authorization for a generic version of FIRDAPSE®.
Teva's ANDA asserts that Catalyst's patents are invalid or not infringed. Catalyst must respond within 45 days to potentially trigger a legal battle that could delay Teva's market entry until May 2026.
Catalyst is committed to enforcing its intellectual property rights regarding FIRDAPSE®, which is used to treat Lambert-Eaton myasthenic syndrome.
Catalyst Pharmaceuticals has announced its acquisition of the U.S. rights for FYCOMPA® (perampanel) from Eisai Co., Ltd for $160 million. The acquisition, expected to close in early 2023, will enhance Catalyst's neurology portfolio, adding a well-established product with projected net revenues of approximately $136 million for Eisai’s fiscal 2022. Additionally, an exclusive option period to evaluate a rare epilepsy compound from Eisai's pipeline is included. Catalyst anticipates that this deal will be accretive to both EBITDA and EPS in 2023.
Catalyst Pharmaceuticals (CPRX) reported a record Q3 2022 net revenue of $57.2 million, a 59.3% increase year-over-year. The company raised its full-year revenue guidance to $205-210 million. Q3 GAAP net income reached $22.7 million ($0.22 per basic share), influenced by a one-time acquisition charge of $4.1 million. Non-GAAP net income also rose to $28.6 million. Cash and investments grew to $256.1 million. Catalyst achieved important milestones, including FDA approval for pediatric use of FIRDAPSE® and the acquisition of Ruzurgi®.
Catalyst Pharmaceuticals (CPRX) has been honored with the 2022 David J. Gury Company of the Year award by BioFlorida, recognizing its significant contributions to the life sciences sector in Florida. The company is celebrated for its innovative treatment, FIRDAPSE®, aimed at patients suffering from Lambert-Eaton Myasthenic Syndrome (LEMS). Catalyst's commitment to addressing unmet medical needs underpins its mission, according to CEO Patrick J. McEnany. The award highlights Catalyst's efforts in improving patient access to essential therapies.
Catalyst Pharmaceuticals (CPRX) will release its third quarter 2022 financial results on November 9, 2022, after market close. A subsequent conference call and webcast will occur on November 10, 2022, at 8:30 AM ET, where the management team will discuss the results and provide a corporate update. FIRDAPSE®, approved in 2018, is available for treating adults and children with Lambert-Eaton myasthenic syndrome in the U.S. and Canada. Forward-looking statements highlight potential risks that may affect results significantly.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced FDA approval for FIRDAPSE® (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS) in patients aged six years and older. This expands the treatment option for pediatric patients, addressing a significant need within a small patient population. FIRDAPSE was previously approved for adults in the U.S. and Canada. The company is committed to ensuring access through its Catalyst Pathways program, which provides support for qualifying patients.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that Patrick J. McEnany, Chairman and CEO, and the management team will attend the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. An on-demand presentation will be accessible to registered attendees on September 12 at 7:00 AM Eastern Time via the conference portal. Additionally, the presentation will be available on Catalyst's website. The company specializes in developing novel medicines for rare diseases, notably with FDA-approved FIRDAPSE® for Lambert-Eaton myasthenic syndrome.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced its participation in Citi's 17th Annual BioPharma Conference on September 7-8, 2022. Chairman and CEO Patrick J. McEnany, along with the management team, will host one-on-one meetings on September 8. Catalyst is dedicated to developing and commercializing innovative medicines for rare diseases, including its recently FDA-approved drug FIRDAPSE® for Lambert-Eaton myasthenic syndrome.
FIRDAPSE is also approved for use in Canada, showcasing Catalyst's commitment to addressing unmet medical needs in rare diseases.
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