Catalyst Pharmaceuticals Inc Stock Price, News & Analysis

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.

Catalyst Pharmaceuticals (NASDAQ: CPRX), a commercial-stage biopharmaceutical company specializing in rare and difficult-to-treat diseases, has announced its participation in the Barclays 27th Annual Global Healthcare Conference.

The company's presentation is scheduled for Tuesday, March 11, 2025, at 1:00 PM ET in Miami, Florida. Richard J. Daly, President and CEO, will lead the presentation along with other management team members.

Investors and interested parties can access the presentation webcast through the Investors section of www.catalystpharma.com. A replay will remain available for a minimum of 30 days following the event.

Catalyst Pharmaceuticals (CPRX) reported strong financial results for Q4 and full year 2024, with total revenues reaching $491.7 million, marking a 23.5% year-over-year growth. The company's portfolio performance was driven by three key products: FIRDAPSE® ($306.0M), AGAMREE® ($46.0M), and FYCOMPA® ($137.3M).

Q4 2024 revenues were $141.8 million, up 28.3% YoY, with GAAP net income of $55.9 million. The company projects 2025 total revenues between $545-565 million, with FIRDAPSE expected to generate $355-360M, AGAMREE $100-110M, and FYCOMPA $90-95M.

Notable achievements include AGAMREE's successful US launch, FIRDAPSE's FDA-approved dose increase, and a settlement agreement with Teva regarding patent litigation. The company ended 2024 with $517.6 million in cash and cash equivalents.

Catalyst Pharmaceuticals (CPRX) has announced it will release its fourth quarter and full-year 2024 financial results after market close on February 26, 2025. The company will host a conference call and webcast the following day, February 27, 2025, at 8:30 AM ET, where management will discuss financial results and provide a business update.

The conference call will be accessible via US/Canada dial-in number (877) 407-8912 and international dial-in (201) 689-8059. A webcast will be available under the Investors section on the company's website, with a replay accessible for at least 30 days following the event.

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.