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 received a Notice of Allowance for U.S. Patent Application Serial Number 14/128,672 from the USPTO. This patent covers methods for treating patients with certain mutations using 3,4-Diaminopyridine (3,4-DAP). The expected patent issuance will protect Catalyst's Firdapse® franchise until at least June 29, 2032, with potential extensions. The company plans to list this patent in the FDA's "Orange Book," blocking generic competition unless challenged. This development supports Catalyst's ongoing research and product expansion in neuromuscular disease therapies.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported second quarter 2020 net revenues of $29.6 million, up from $28.8 million in Q2 2019. Net income was $9.8 million or $0.09 per share. The company received Health Canada marketing authorization for Firdapse® for LEMS treatment. However, the Phase 3 trial for anti-MuSK-MG did not achieve statistical significance for primary or secondary endpoints. Catalyst ended the quarter with $115.1 million in cash and no debt, while continuing various clinical development programs and expansion efforts in Canada and Japan.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced Health Canada’s approval of Firdapse® (amifampridine) for treating Lambert-Eaton myasthenic syndrome (LEMS), a rare neurodegenerative condition. The approval was granted under Priority Review based on data from two multinational clinical trials. Firdapse® was previously approved in the U.S. and Europe. Catalyst is exploring partnerships for distribution in Canada and aims to expand Firdapse® indications. LEMS is often linked to autoimmune disorders and can be life-threatening.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has transitioned its 2020 Annual Meeting of Stockholders to a virtual-only format due to the COVID-19 pandemic. The meeting is scheduled for August 20, 2020, at 9:00 AM ET. Stockholders can participate in voting and submitting questions via an online platform. Only those registered by June 22, 2020, can attend. The company has provided detailed instructions for both registered and street name stockholders to register for the meeting. Additionally, the Proxy Statement and related information are available on their website.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q2 2020 financial results after market close on August 10, 2020. An investment-community conference call is scheduled for August 11, 2020, at 8:30 a.m. ET to discuss the results and provide a corporate update. Investors can participate by calling (877) 407-8912 for domestic and (201) 689-8059 for international callers, or stream via the company's website. A webcast replay will be available for 30 days post-call.
Catalyst Pharmaceuticals (CPRX) announced a disappointing recommendation from a Magistrate Judge regarding its lawsuit against the FDA, advising to deny Catalyst's motion for summary judgment. The recommendation, which Catalyst believes is legally flawed, could jeopardize the exclusivity benefits of the Orphan Drug Act. Chairman Patrick J. McEnany stated that if upheld, the decision could discourage investment in orphan drug development. Despite this setback, Catalyst remains committed to protecting its drug Firdapse® from competition.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced several leadership promotions, including Jeffrey Del Carmen to Chief Commercial Officer. Del Carmen, who previously served as Senior Vice President of Sales and Marketing, will lead efforts to expand access to the company's Firdapse product for Lambert-Eaton myasthenic syndrome (LEMS) and prepare for a potential launch for anti-MuSK antibody positive myasthenia gravis. The company also promoted Pete Curry to Vice President of Sales and Maria Pandolfo to Vice President of Patient Services.
Catalyst Pharmaceuticals, focused on rare neuromuscular diseases, announced its presentation at the Jefferies Virtual Healthcare Conference on June 2-4, 2020. CEO Patrick J. McEnany and CSO Steven Miller will host one-on-one investor meetings, with their presentation on June 4 at 8:30 a.m. E.T. The event will be accessible via the company's investor webpage. Catalyst's Firdapse® (amifampridine) is FDA-approved for Lambert-Eaton myasthenic syndrome and is under evaluation for other conditions. The press release emphasizes Catalyst's commitment to innovative therapies.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported Q1 2020 net revenues of $29.1 million, a 134% increase from the previous year. The company achieved a GAAP net income of $10.4 million or $0.10 per share, compared to a loss of $645,000 in Q1 2019. Catalyst withdrew its 2020 revenue guidance due to COVID-19 uncertainties while highlighting minimal impact on Q1 revenues. The firm ended the quarter with $101.8 million in cash and no debt and expanded its sales force to enhance the Firdapse franchise. Upcoming milestones include Phase 3 trial results for MuSK-MG expected in Q3 2020.
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