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) reported record Q2 2022 net product revenues of $53.0 million, marking a 57.7% year-over-year increase. Cash and short-term investments totaled $220.8 million with no funded debt. The company completed the acquisition of Ruzurgi® U.S. and Mexico rights, potentially extending FIRDAPSE patent protection to 2037. Catalyst forecasts full-year adjusted EBITDA between $100-105 million and expects total revenues between $195-205 million, reflecting a 38%-45% increase from 2021.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q2 2022 financial results after market close on August 9, 2022. A conference call and webcast are scheduled for August 10, 2022, at 8:30 AM ET, where management will discuss the results and provide a corporate update. The event can be accessed via the company's website, and a replay will be available for 30 days. Catalyst focuses on developing medicines for rare diseases, with its FDA-approved product FIRDAPSE® for Lambert-Eaton myasthenic syndrome.
Catalyst Pharmaceuticals announced a settlement with Jacobus Pharmaceutical, acquiring rights to Ruzurgi in the U.S. and Mexico. This settlement resolves patent infringement litigation where Catalyst claimed Jacobus induced infringement related to FIRDAPSE. Notably, Ruzurgi is not FDA-approved for U.S. distribution due to legal complications. Catalyst plans to continue supplying Ruzurgi to patients under investigator-sponsored INDs while focusing on the LEMS patient community. Catalyst will pay Jacobus cash and a royalty on U.S. net sales of amifampridine.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced participation in two upcoming investment conferences. CEO Patrick J. McEnany and the management team will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 4 PM ET, and the Jefferies Healthcare Conference on June 8, 2022, at 11 AM ET. A webcast will be available on their website, with a replay for 14 days. Catalyst focuses on developing treatments for rare diseases and has FDA-approved FIRDAPSE for Lambert-Eaton myasthenic syndrome.
Catalyst Pharmaceuticals (CPRX) reported record revenue of $43.1 million for Q1 2022, marking a 42.7% year-over-year increase. This growth is attributed to increased patient conversions to FIRDAPSE® after Ruzurgi® was removed from the U.S. market. The company affirmed its full-year revenue guidance of $195 million to $205 million, expecting a 38% to 45% revenue growth from 2021. Catalyst's cash position stands at $198 million with no debt. It continues to enhance its patent portfolio and expand treatment options for rare diseases.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced it will release its first-quarter 2022 financial results on May 10, 2022, after market close. A conference call and webcast will be hosted the next morning, May 11, 2022, at 8:30 AM ET, to discuss financial results and provide corporate updates. Catalyst focuses on developing medicines for patients with rare diseases, with its FIRDAPSE® medication approved for Lambert-Eaton myasthenic syndrome. Further details and a replay of the webcast will be available on the company's website.
Catalyst Pharmaceuticals (CPRX) reported a 2021 revenue increase of 18% YoY, reaching $141 million. The fourth quarter saw revenues of $38 million, up 24% from 2020. Catalyst anticipates 2022 revenues between $195 million and $205 million, bolstered by orphan drug exclusivity for FIRDAPSE and new patent issuances extending exclusivity to 2034. Cash and investments stand at $191 million with no funded debt. The company is actively pursuing opportunities to diversify its portfolio and will host a conference call on March 17, 2022, for further updates.
Catalyst Pharmaceuticals (CPRX) announced a favorable ruling from the Federal Court of Canada, reversing Health Canada's decision on Ruzurgi (amifampridine) for Lambert-Eaton Myasthenic Syndrome (LEMS). The Court found that Health Canada improperly evaluated data linked to the Innovative Drug status of FIRDAPSE, which protects its data for eight years. Catalyst expressed satisfaction with the ruling, emphasizing its commitment to making Ruzurgi accessible to LEMS patients in Canada.
Catalyst Pharmaceuticals (CPRX) will release its Q4 and FY 2021 financial results on March 16, 2022, after market close. A conference call and webcast will follow on March 17, 2022, at 8:30 AM ET to discuss these results and provide a corporate update. The company's FIRDAPSE (amifampridine) Tablets, approved for treating adults with Lambert-Eaton myasthenic syndrome, is currently available in the U.S. and Canada. Catalyst emphasizes a commitment to developing innovative medicines for rare diseases.
FAQ
What is the current stock price of Catalyst Pharmaceutical (CPRX)?
What is the market cap of Catalyst Pharmaceutical (CPRX)?
What does Catalyst Pharmaceuticals Inc. focus on?
What is Firdapse®?
What recent progress has Firdapse® made?
What other products is Catalyst developing?
Has Firdapse® been approved for use in Europe?
How is Catalyst Pharmaceuticals financially positioned?
What is Catalyst's approach to drug development?
What recent news is there about Catalyst Pharmaceuticals?
When is Catalyst's next conference call and webcast?
Where can I find more information about Catalyst Pharmaceuticals?
