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Catalyst Pharmaceuticals, Inc. - $CPRX STOCK NEWS

Welcome to our dedicated page for Catalyst Pharmaceuticals news (Ticker: $CPRX), a resource for investors and traders seeking the latest updates and insights on Catalyst Pharmaceuticals 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.
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Catalyst Pharmaceuticals has received FDA approval to increase the maximum daily dose of FIRDAPSE® from 80 mg to 100 mg for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients over 45 kg. This adjustment provides more flexibility in treatment options for both adult and pediatric patients. FIRDAPSE, a potassium channel blocker, is the only FDA-approved treatment for LEMS, a rare autoimmune disorder that causes muscle weakness and fatigue. Catalyst's CEO Richard J. Daly highlighted the significance of this approval in enhancing patient outcomes. The Catalyst Pathways® Patient Assistance Program offers additional support for those seeking treatment information.

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Catalyst Pharmaceuticals announced its participation in the Jefferies Global Healthcare Conference 2024, scheduled for June 5, 2024, in New York. CEO Richard J. Daly and other management members will represent the company at the event. The presentation will be available via webcast on the Catalyst Pharmaceuticals website and archived for 14 days. Catalyst focuses on in-licensing, developing, and commercializing novel treatments for rare and difficult-to-treat diseases. This event represents an opportunity for Catalyst to showcase its progress and future plans to investors and industry stakeholders.

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Catalyst Pharmaceuticals reported solid first-quarter 2024 financial results, achieving total revenues of $98.5 million, a 15.4% YoY increase. Highlights include the successful launch of AGAMREE®, robust revenue momentum for FIRDAPSE®, and reaffirmed full-year 2024 total revenue guidance of $455-475 million.

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Catalyst Pharmaceuticals, Inc. will participate in the BofA Securities Health Care Conference 2024. Richard J. Daly, President and CEO, will lead the team at the event in Las Vegas, Nevada. The presentation will take place on May 14, 2024, at 5:00 pm PT. Investors can access the webcast on the company's website with a replay available for at least 14 days.

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Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) will report its first quarter 2024 financial results on May 8, 2024, followed by a conference call and webcast on May 9, 2024, at 8:30 AM ET. The company focuses on developing medicines for rare diseases.
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Catalyst Pharmaceuticals, Inc. endorses the inaugural Lambert-Eaton myasthenic syndrome Awareness Day, marking a significant milestone for the LEMS community. The event, observed annually on March 30th, commemorates the groundbreaking research of Dr. Lambert and Dr. Eaton, enhancing understanding and treatment of this rare disorder. Catalyst emphasizes the importance of raising awareness for rare diseases, aiming to improve support and care for affected individuals.
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Catalyst Pharmaceuticals, Inc. announced CEO Richard J. Daly's participation in the 2024 Cantor Virtual Muscular Dystrophy Symposium. The event will take place on April 2-3, 2024, at 3:10 PM ET. The presentation will be available on the Company's website with a replay for 14 days.
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Catalyst Pharmaceuticals, Inc. announces the U.S. commercial launch of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy patients aged two years and older. The drug offers a promising alternative to traditional corticosteroid treatments, aiming to improve patient quality of life with reduced side effects. Catalyst Pathways® program supports patient access and affordability, emphasizing the company's commitment to providing comprehensive care.
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Catalyst Pharmaceuticals, Inc. CEO Richard J. Daly and management team to participate in Barclays 26th Annual Global Healthcare Conference in Miami. The event includes 1x1 meetings and a fireside discussion on March 12, 2024, with a live webcast and replay available on the company's website.
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Catalyst Pharmaceuticals, Inc. reported strong financial results for the fourth quarter and full year 2023, with record total revenues of $398.2 million, an 85.9% increase compared to 2022. The company achieved record net product revenues and reported GAAP net income of $71.4 million. The FDA approval of AGAMREE for Duchenne muscular dystrophy and the upcoming commercial launch in Q1 2024 are key highlights. Catalyst provided a full-year 2024 revenue guidance of $455 million to $475 million and announced key executive appointments and strategic collaborations.
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FAQ

What does Catalyst Pharmaceuticals Inc. focus on?

Catalyst Pharmaceuticals Inc. focuses on developing and commercializing therapies for rare, debilitating neuromuscular and neurological diseases.

What is Firdapse®?

Firdapse® is a proprietary form of amifampridine phosphate developed by Catalyst Pharmaceuticals for the treatment of Lambert-Eaton myasthenic syndrome (LEMS).

What recent progress has Firdapse® made?

Firdapse® has completed a pivotal Phase 3 trial with positive results and has filed an NDA with the FDA for treating LEMS and CMS. It has also received breakthrough therapy and orphan drug designations.

What other products is Catalyst developing?

Catalyst is developing CPP-115 for treating infantile spasms, epilepsy, and other neurological conditions.

Has Firdapse® been approved for use in Europe?

Yes, Firdapse® is the first and only European-approved drug for the symptomatic treatment of adults with LEMS.

How is Catalyst Pharmaceuticals financially positioned?

Catalyst Pharmaceuticals has a strong financial foundation that supports continued investment in research and development as well as strategic partnerships.

What is Catalyst's approach to drug development?

Catalyst emphasizes addressing unmet medical needs in rare diseases through rigorous research and development and strategic partnerships.

What recent news is there about Catalyst Pharmaceuticals?

Recent news includes Santhera's study on Vamorolone for DMD and Catalyst's financial highlights and upcoming 2024 outlook webcast.

When is Catalyst's next conference call and webcast?

The next conference call and webcast is scheduled for February 29, 2024, at 8:30 AM ET to discuss financial results and provide a business update.

Where can I find more information about Catalyst Pharmaceuticals?

More information is available on Catalyst Pharmaceuticals' official website and under the investor section for news and updates.

Catalyst Pharmaceuticals, Inc.

Nasdaq:CPRX

CPRX Rankings

CPRX Stock Data

1.84B
101.65M
6.21%
83.33%
6.77%
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