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 achieved a remarkable fifth place ranking on Forbes' 2025 list of America's Most Successful Mid-Cap Companies. This achievement follows their fourth-place position on Forbes' Small-Cap Companies list from the previous year, demonstrating the company's successful growth trajectory.
The ranking criteria included earnings growth, sales growth, return on equity, and total stock return over a five-year period, with greater emphasis on the most recent year's performance. Forbes' selection process involved screening over 700 companies with market values between $2 billion and $10 billion, requiring positive sales growth over 12 months and a minimum share price of $5. The data was collected as of November 27, 2024.
Companies excluded from consideration included financial institutions, REITs, utilities, partnerships, and those public for less than one year. CEO Rich Daly attributed this success to their growth and investment strategy, emphasizing their commitment to patient care and stakeholder value creation.
Catalyst Pharmaceuticals (CPRX) announced that its sub-licensee DyDo Pharma has launched FIRDAPSE® (amifampridine) Tablets 10 mg in Japan. The drug is approved for improving muscle weakness in patients with Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder.
FIRDAPSE is the only FDA-approved therapy for LEMS treatment in adults and pediatric patients six years and older. This launch represents an expansion of Catalyst's geographic footprint and increases access to the therapy for Japanese patients. In the U.S., FIRDAPSE is supported by a comprehensive patient support program to ensure accessibility for eligible patients.
Catalyst Pharmaceuticals (CPRX) and its licensor SERB S.A. have reached a settlement agreement with Teva Pharmaceuticals regarding patent litigation over FIRDAPSE® (amifampridine). The litigation was initiated after Teva filed an Abbreviated New Drug Application seeking to market a generic version of FIRDAPSE 10 mg tablets before patent expiration.
Under the agreement, Teva will not market its generic version of FIRDAPSE in the United States before February 25, 2035, pending FDA approval. The ongoing patent litigation between Catalyst/SERB and Teva in the U.S. District Court for the District of New Jersey will be terminated. However, patent litigation continues against other defendants, including Hetero and Lupin.
Catalyst Pharmaceuticals (NASDAQ: CPRX), a commercial-stage biopharmaceutical company specializing in rare and difficult-to-treat diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's President and CEO, Richard J. Daly, will deliver a presentation on Thursday, January 16, 2025, at 10:30 am PST in San Francisco.
The presentation will be accessible via webcast through the Investors section of Catalyst's website, with a replay available for a minimum of 30 days following the event. This conference represents a significant platform for Catalyst to showcase its developments in novel medicines and treatments.
Catalyst Pharmaceuticals (NASDAQ: CPRX) has been ranked 452nd on the 2024 Deloitte Technology Fast 500™ list, showcasing North America's fastest-growing companies across technology, media, telecommunications, life sciences, fintech, and energy tech sectors. The company achieved 234% revenue growth between 2020 and 2023, attributed to operational excellence and strong commercial execution.
The 30th annual rankings featured companies with growth rates ranging from 201% to 153,625%, with an average of 1,981% and a median of 460%. Notably, this year marked a significant breakthrough in private company performance, with the software and fintech sectors showing particularly strong representation.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced its participation in two major upcoming investor conferences. The company's President and CEO Richard J. Daly, along with other management team members, will present at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 2:00 PM ET, and at Citi's 2024 Global Healthcare Conference on Wednesday, December 4, 2024, at 1:00 PM ET. Both presentations will be available via webcast on the company's website under the Investors section, with replays accessible for at least 30 days.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has been named among the BioSpace 2025 Best Places to Work, joining 50 other U.S. employers recognized as the most sought-after in the industry. The recognition comes from votes and ratings by thousands of life sciences community members, evaluating companies based on culture, career growth, leadership, and innovation.
The selection process, conducted in 2024, involved nominations in June and voting in August, with over 3,000 life sciences professionals rating organizations on factors including compensation, innovation, career opportunities, leadership, culture, DEI, reputation, and work flexibility. President and CEO Richard J. Daly highlighted the company's commitment to creating an environment that promotes growth, development, and trust while focusing on improving patient care for rare diseases.
Catalyst Pharmaceuticals reported strong Q3 2024 financial results with total revenues of $128.7 million, up 25.3% year-over-year. The company's performance was driven by FIRDAPSE net product revenues of $79.3 million (+19.7% YoY), AGAMREE revenues of $15.0 million, and FYCOMPA revenues of $32.1 million. Q3 GAAP net income reached $43.9 million ($0.35 per diluted share), while non-GAAP net income was $71.1 million ($0.57 per diluted share). The company updated its 2024 full-year total revenue guidance to between $475-485 million, with cash and cash equivalents at $442.3 million as of September 30, 2024.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced that it will release its third quarter 2024 financial results after the market close on Wednesday, November 6, 2024. The company's management team will host a conference call and webcast on Thursday, November 7, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.
Interested parties can access the conference call via the following dial-in numbers:
- US/Canada: 800-715-9871
- International: 646-307-1963
Catalyst Pharmaceuticals, a commercial-stage biopharmaceutical company focused on rare diseases, has donated $100,000 to the American Red Cross for Hurricane Helene relief efforts. The donation aims to support communities impacted by the widespread devastation caused by the hurricane. Richard J. Daly, President and CEO of Catalyst, expressed the company's commitment to helping those affected during this crisis.
Anne McKeough, Chief Development Officer at the American Red Cross, thanked Catalyst for their generous contribution. The Red Cross has mobilized over 1,400 disaster responders across the Carolinas, Tennessee, Georgia, and Florida to provide shelter, meals, and comfort to families facing destruction. Catalyst's donation will help sustain these vital efforts and bring hope to those in need.
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