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) will release its second quarter 2021 financial results on August 9, 2021, after market close. An investment-community conference call is scheduled for August 10, 2021, at 8:30 a.m. ET to discuss these results and provide a corporate update. Investors can participate either by phone or by listening online through the company’s website.
With a focus on rare diseases, Catalyst continues its commitment to developing high-quality medicines, including Firdapse®, which is already approved for LEMS treatment in the U.S. and Canada.
Catalyst Pharmaceuticals (CPRX) announced a new patent for Firdapse® (amifampridine) Tablets, U.S. Patent No. 11,060,128, enhancing its intellectual property protection. This patent addresses innovative dosing methods for slow metabolizers of amifampridine, particularly in treating Lambert-Eaton myasthenic syndrome (LEMS). Catalyst is pursuing additional patents, optimistic about their approval. The company aims to support the neuromuscular community and is investigating Firdapse® for other rare diseases, alongside ongoing clinical trials for myasthenia gravis.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has appointed Dr. Preethi Sundaram as the Chief Product Development Officer. Dr. Sundaram brings over 20 years of experience in product development, having held various leadership roles at Sanofi and other companies. In this newly created position, she will oversee Catalyst's product pipeline, focusing on therapies for rare diseases. The company aims to enhance its R&D strategy and expedite the development of innovative treatment options. Catalyst's FDA-approved drug Firdapse® is already on the market for LEMS, with ongoing clinical trials for MuSK-MG.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the appointment of Molly Harper to its Board of Directors. Harper brings over 20 years of experience in life sciences, specializing in rare disease drug development and commercialization. Currently, she serves as Executive Vice President of Operations at Relmada Therapeutics and has held senior positions at Akcea Therapeutics and Sanofi Genzyme. The Board's chairman expressed confidence in her ability to strengthen the company's growth strategy as Catalyst focuses on expanding its portfolio of medicines for rare diseases.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that Health Canada has re-issued a Notice of Compliance for Ruzurgi® (amifampridine), allowing it to be marketed for Lambert-Eaton Myasthenic Syndrome (LEMS) patients. This decision follows a prior court ruling that quashed the original NOC. CEO Patrick McEnany expressed disappointment over the decision, which affects their market opportunity in Canada. Catalyst and KYE Pharmaceuticals are considering legal action to challenge this ruling, as it does not honor the data protection rights they hold under Canadian law.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has entered an exclusive license and supply agreement with DyDo Pharma for the development and commercialization of Firdapse® (amifampridine) in Japan, targeting Lambert-Eaton myasthenic syndrome (LEMS). DyDo Pharma will fund all related activities and hold exclusive commercialization rights in Japan, while Catalyst will oversee supply and provide support for regulatory approval. Catalyst will receive an upfront payment and potential milestones. The partnership aims to address the unmet medical needs for LEMS in Japan.
Catalyst Pharmaceuticals (CPRX) announced a significant ruling from the Canadian Federal Court, which has quashed the Notice of Compliance for Ruzurgi® previously granted by Health Canada. This decision emphasizes the protection of Firdapse®'s data exclusivity, allowing a review of Ruzurgi®'s marketing authorization. As a result, Ruzurgi® currently lacks marketing authorization in Canada, impacting its commercial prospects. The ruling highlights the ongoing complexities in drug submissions and the importance of adhering to data protection regulations.
Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX) announced participation in two investor conferences. The Oppenheimer Rare & Orphan Disease Summit will feature Catalyst’s pre-recorded presentation on May 21, 2021, at 8:00 a.m. EDT, followed by virtual meetings. The Jefferies Virtual Healthcare Conference will see Catalyst present on June 2, 2021, at 4:00 p.m. EDT, with additional virtual meetings throughout the day. Catalyst specializes in developing high-quality medicines for rare diseases and seeks to expand its pipeline, notably with Firdapse® for LEMS.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported Q1 2021 net revenues of $30.2 million, up from $29.1 million in Q1 2020. GAAP net income was $7.7 million ($0.07 per share), a decrease from $10.4 million ($0.10 per share) in the same period last year. The company has $143.3 million in cash and no funded debt. Catalyst recently received Orphan Drug Designation for Firdapse® in Japan. The firm plans to expand investments in R&D and other therapeutic areas, aligning with its new strategic focus. A conference call is scheduled for May 11, 2021, to discuss further details.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q1 2021 financial results after market close on May 10, 2021. A conference call is scheduled for May 11, 2021, at 8:30 a.m. ET to discuss the results and provide corporate updates. Catalyst focuses on developing high-quality medicines for rare diseases, with Firdapse® (amifampridine) currently being evaluated for MuSK-MG and recently approved in Canada for LEMS. The company is committed to a robust pipeline of medicines and maintains transparency regarding known risks in its forward-looking statements.
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