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 reported strong financial results for Q3 2021, achieving $35.9 million in FIRDAPSE revenue, a 23.1% increase year-over-year. The company plans to expand U.S. approval of FIRDAPSE to include pediatric LEMS patients. Catalyst's cash position stands at $174.8 million, bolstering its long-term growth strategy. The company also received favorable court support for orphan drug exclusivity and made strategic decisions for sustainable growth. However, GAAP net income for Q3 2021 was $10.3 million, down from $43.3 million in Q3 2020, due to a significant prior year tax asset.
Catalyst Pharmaceuticals (CPRX) announced it will release its Q3 2021 financial results after market close on November 9, 2021. Following this, a conference call and webcast are scheduled for November 10, 2021, at 8:30 AM EST to discuss the results and provide a corporate update. The call can be accessed via US/Canada dial-in at (877) 407-8912 or international at (201) 689-8059. Catalyst focuses on developing medicines for rare diseases, notably FIRDAPSE, approved in the US and Canada for LEMS treatment.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced a favorable ruling from the 11th Circuit Court of Appeals regarding the FDA approval of Ruzurgi® for pediatric LEMS patients, which conflicted with Catalyst's Orphan Drug exclusivity for Firdapse® (amifampridine). The court remanded the case to enforce Catalyst's exclusivity rights. Catalyst aims to ensure uninterrupted access to Firdapse® for patients, including transitioning from Ruzurgi®. The company emphasizes the importance of Orphan Drug incentives in developing treatments for rare diseases, especially given the 6,500 rare diseases without approved therapies.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that its CEO Patrick J. McEnany and CSO/COO Steven Miller, Ph.D., will participate in the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2021, at 9:05 AM EDT. The event will feature a presentation and virtual one-on-one meetings. The webcast will be available on the company's website, with a replay accessible for 14 days. Catalyst focuses on developing high-quality medicines for rare diseases, including Firdapse® for LEMS. Firdapse® is also being evaluated for MuSK-MG and has received Orphan Drug Designation.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), a biopharmaceutical company focused on rare diseases, announced participation in two investor conferences. The H.C. Wainwright 23rd Annual Global Investment Conference is set for September 13-15, 2021, featuring a pre-recorded presentation available on-demand starting September 13 at 7:00 AM EDT. The 2021 Cantor Virtual Global Healthcare Conference will take place September 27-30, with a presentation on September 28 at 1:20 PM EDT. More details are accessible on their website.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the appointment of Mary Coleman as Vice President, Head of Investor Relations, a newly created position reporting to the CEO. Coleman's 20 years of experience in investor relations within the biotech sector positions her to enhance Catalyst's investor relations program. Her role will support the company's growth strategy and strengthen its reputation in the investment community. Catalyst is committed to developing innovative medicines for rare diseases, with its flagship product, Firdapse®, already approved in the U.S. and Canada.
Catalyst Pharmaceuticals (CPRX) reported a Q2 2021 total net revenue of $36.4 million, up 23% year-over-year, driven by Firdapse® product sales of $33.6 million. The GAAP net income was $12.2 million, or $0.12 per share, an improvement from $9.8 million in Q2 2020. Catalyst holds $155.3 million in cash with no funded debt. The company aims to enhance its operational portfolio and commercialization efforts, evidenced by recent leadership expansions and partnerships, including an exclusive agreement with DyDo Pharma for Firdapse® in Japan.
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.
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