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. (NASDAQ: CPRX) is a biopharmaceutical leader focused on rare neuromuscular and neurological disorders, including its FDA-approved therapy for Lambert-Eaton Myasthenic Syndrome (LEMS). This page provides official updates and analysis of Catalyst's developments in drug commercialization, regulatory milestones, and clinical research.
Investors and healthcare professionals can monitor critical updates including FDA decisions, clinical trial progress, and strategic partnerships. All content is sourced from verified filings, press releases, and reputable financial analysis to ensure accuracy.
Key focus areas include developments around Firdapse® commercialization, pipeline advancements for CPP-115, and regulatory strategies for orphan drug designations. The curated news collection enables efficient tracking of Catalyst's position in the competitive rare disease therapeutics market.
Bookmark this page for consolidated access to Catalyst's latest business and scientific developments. Check regularly for updates impacting the company's growth trajectory in a sector where regulatory approvals directly influence market performance.
Catalyst Pharmaceuticals (NASDAQ:CPRX) reported strong Q2 2025 financial results, with total revenues reaching $146.6 million, up 19.4% year-over-year. The company's portfolio showed broad growth, led by FIRDAPSE® ($84.8M, +9.7% YoY), AGAMREE® ($27.4M, +212.9% YoY), and FYCOMPA® ($34.3M).
First half 2025 revenues totaled $288.0 million, a 30.2% increase over 2024. The company maintains its full-year 2025 revenue guidance of $545-565 million. Q2 GAAP net income was $52.1 million ($0.41 per diluted share), up 27.7% YoY. Catalyst ended Q2 with a strong cash position of $652.8 million and no funded debt.
Catalyst Pharmaceuticals (NASDAQ:CPRX) announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for Small Cell Lung Cancer (SCLC) to include important recommendations for Lambert Eaton Myasthenic Syndrome (LEMS).
The updated guidelines now include testing for PQ- and N-type voltage-gated calcium channel (VGCC) antibodies and recommend neurological evaluation for diagnosis. Additionally, amifampridine (FIRDAPSE®) is now recommended as a potential treatment option in consultation with neurology.
Notably, approximately 50% of LEMS cases are associated with underlying malignancy, primarily SCLC, with LEMS observed in 3% of SCLC patients. Internal analysis suggests that 90% of LEMS patients with SCLC may be undiagnosed, highlighting a significant unmet medical need.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has appointed Daniel Curran, MD to its Board of Directors. Dr. Curran brings over 25 years of pharmaceutical industry experience, currently serving as Managing Partner of Mountainfield Venture Partners and CEO of Timberlyne Therapeutics.
Dr. Curran's extensive background includes a significant tenure at Takeda Pharmaceutical Company (2008-2023), where he last served as Senior Vice President and Head of Rare Genetics and Hematology Therapeutic Area Unit. His expertise spans strategy, business development, and rare disease therapeutics, making him well-positioned to support Catalyst's growth strategy in rare disease treatments.
Catalyst Pharmaceuticals (NASDAQ: CPRX), a commercial-stage biopharmaceutical company specializing in rare and difficult-to-treat diseases, has scheduled its second quarter 2025 financial results release for August 6, 2025 after market close.
The company will host a conference call and webcast the following day, Thursday, August 7, 2025, at 8:30 AM ET to discuss financial results and provide a business update. Investors can access the call via US/Canada dial-in (877) 407-8912 or international dial-in (201) 689-8059. The webcast will be available on the Investors section of Catalyst's website with a replay accessible for at least 30 days.
Catalyst Pharmaceuticals (Nasdaq: CPRX), a commercial-stage biopharmaceutical company, will participate in the upcoming BofA Securities Health Care Conference 2025. The company's President and CEO Richard J. Daly, along with other management team members, will present at the conference.
The presentation is scheduled for Wednesday, May 14, 2025, at 8:00 am PT at the Encore Hotel in Las Vegas, Nevada. Investors and interested parties can access the webcast through the Investors section of Catalyst's website at www.catalystpharma.com. A replay of the presentation will remain available for at least 14 days following the event.
Catalyst focuses on in-licensing, developing, and commercializing novel medicines for patients with rare and difficult-to-treat diseases.
Catalyst Pharmaceuticals (CPRX), a commercial-stage biopharmaceutical company specializing in rare and difficult-to-treat diseases, has scheduled its first quarter 2025 financial results release for May 7, 2025, after market close.
The company will host a conference call and webcast the following day, May 8, 2025, at 8:30 AM ET. During this event, management will discuss financial results and provide a business update. Investors can access the webcast through the Investors section of Catalyst's website, with a replay available for at least 30 days after the event.
Catalyst Pharmaceuticals (NASDAQ: CPRX) announced that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE® with Priority Review status, submitted by their Canadian sub-licensee Kye Pharmaceuticals. AGAMREE, a novel corticosteroid treatment for Duchenne muscular dystrophy (DMD), could potentially receive marketing authorization before the end of 2025.
If approved, AGAMREE would become the first and only treatment option for DMD patients in Canada. The drug recently received FDA approval on October 26, 2023, for DMD treatment in patients aged two years and older, and became commercially available in the U.S. on March 13, 2024.
Kye Pharmaceuticals currently markets Catalyst's flagship product FIRDAPSE® in Canada for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disorder.
Kye Pharmaceuticals has announced that Health Canada has accepted their New Drug Submission (NDS) for AGAMREE® (vamorolone) with priority review status for treating Duchenne muscular dystrophy (DMD). If approved, AGAMREE® would become the first and only Health Canada-approved therapy for DMD, with potential marketing authorization by the end of 2025.
The submission follows AGAMREE's approvals in the US (2023) and European Union (early 2024). According to the Canadian Neuromuscular Disease registry, over 800 boys and young men in Canada live with DMD, a rare disease causing muscle weakness due to lack of dystrophin protein.
The drug's development included clinical trials across five Canadian sites, contributing to its global approval. Patient organizations, including Defeat Duchenne Canada and Muscular Dystrophy Canada, have welcomed this development, highlighting the current lack of approved treatments in Canada.
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