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Catalyst Pharmaceutical Inc. - CPRX STOCK NEWS

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.
News

Catalyst Pharmaceuticals Announces AGAMREE® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (DMD)

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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 to Participate at the Barclays 26th Annual Global Healthcare Conference

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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 Reports Strong Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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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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Catalyst Pharmaceuticals to Present at MDA Clinical & Scientific Conference Details of Registry for Study of Long-Term Safety and Quality of Life in Duchenne Muscular Dystrophy Patients Treated with AGAMREE

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Catalyst Pharmaceuticals, Inc. (CPRX) announces an upcoming poster presentation at the American Academy of Neurology Annual Meeting showcasing Firdapse data for LEMS patients. The company continues its commitment to developing innovative treatments for rare diseases.
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Catalyst Pharmaceuticals Announces Publication of Santhera Pharmaceutical’s VISION-DMD Vamorolone (AGAMREE®) Study Results in the Peer-Reviewed Journal Neurology

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Santhera's study on Vamorolone in Duchenne Muscular Dystrophy patients showed positive long-term efficacy and safety results, supporting the use of Vamorolone. The study demonstrated that Vamorolone was well-tolerated and effective in improving motor outcomes over 48 weeks, with potential benefits in growth and bone health.
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Catalyst Pharmaceuticals to Report Fourth Quarter and Full-Year 2023 Financial Results on February 28, 2024

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Catalyst Pharmaceuticals, Inc. announces a conference call and webcast to discuss its fourth quarter and full-year 2023 financial results. The event will take place on February 29, 2024, at 8:30 AM ET.
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Catalyst Pharmaceuticals, Inc. Announces Closing of Public Offering

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Catalyst Pharmaceuticals, Inc. (CPRX) closes underwritten public offering, selling 10,000,000 shares at $15.00 per share, generating approximately $140.1 million in net proceeds. The company plans to use the funds for potential acquisition of new product candidates and general corporate purposes.
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Catalyst Pharmaceuticals, Inc. Announces Pricing of Public Offering of Common Stock

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Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $15.00 per share, totaling gross proceeds of $150,000,000 before deducting underwriting discounts and expenses. Catalyst also granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of its common stock offered in the public offering. The offering is expected to close soon.
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Catalyst Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock

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Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) has announced the commencement of an underwritten public offering of $150,000,000 of its common stock. The company also plans to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock. The offering is subject to market conditions, and the net proceeds will be used to fund the potential acquisition of new product candidates and for general corporate purposes.
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Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma

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Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that its collaboration partner, DyDo Pharma, Inc., has submitted a New Drug Application to Japan's Pharmaceuticals and Medical Devices Agency seeking marketing approval for FIRDAPSE for the treatment of Lambert Eaton myasthenic syndrome in Japan. The review period is expected to be approximately a minimum of nine months from the submission date. This submission represents a pivotal milestone in the mission to broaden FIRDAPSE’s access as a treatment for LEMS patients in Japan, potentially offering a novel treatment option for Japanese individuals grappling with this condition. Catalyst is also eligible to receive a milestone payment from DyDo and extend its territorial rights to develop and market the product in other key markets in Asia, Central, and South America.
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FAQ

What is the current stock price of Catalyst Pharmaceutical (CPRX)?

The current stock price of Catalyst Pharmaceutical (CPRX) is $21.27 as of December 20, 2024.

What is the market cap of Catalyst Pharmaceutical (CPRX)?

The market cap of Catalyst Pharmaceutical (CPRX) is approximately 2.5B.

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.

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Catalyst Pharmaceutical Inc.

Nasdaq:CPRX

CPRX Rankings

#1793 Ranked by Market Cap
N/A Ranked by Dividends

CPRX Stock Data

2.51B
112.01M
6.02%
82.24%
4.76%
Biotechnology
Pharmaceutical Preparations
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