Catalyst Pharmaceuticals Inc Stock Price, News & Analysis

Catalyst Pharmaceuticals (NASDAQ:CPRX) has reached a settlement agreement with Lupin Pharmaceuticals regarding patent litigation for FIRDAPSE® (amifampridine). Under the agreement, Lupin will not market its generic version of FIRDAPSE until February 25, 2035, pending FDA approval.

The settlement resolves the litigation initiated by Catalyst and SERB S.A. in response to Lupin's Abbreviated New Drug Application (ANDA). All ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey will be terminated. This follows similar settlements with Teva Pharmaceuticals and Inventia Healthcare Limited, while litigation against Hetero remains ongoing.

Catalyst Pharmaceuticals (NASDAQ:CPRX) has announced a settlement agreement with Lupin Pharmaceuticals regarding patent litigation for FIRDAPSE® (amifampridine). Under the agreement, Lupin receives a license to market a generic version of FIRDAPSE starting February 25, 2035, pending FDA approval.

The settlement resolves the patent litigation initiated by Catalyst and SERB S.A. in response to Lupin's Abbreviated New Drug Application (ANDA). All ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey will be terminated. This follows similar settlements with Teva Pharmaceuticals and Inventia Life Science, while litigation against Hetero remains ongoing.

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) has appointed William T. Andrews, MD, FACP as its new Chief Medical Officer, succeeding Dr. Gary Ingenito who is retiring after 10 years with the company. Dr. Andrews brings 24 years of global biopharmaceutical experience, with 18 years specifically focused on rare diseases. Prior to joining Catalyst, he served as President and CEO of Lighthouse Bio, a rare disease-focused startup, and founded Aletheia Lifesciences, a biopharmaceutical consultancy. His experience includes CMO roles at Flexion Therapeutics, Akcea Therapeutics, and Acer Therapeutics. Dr. Andrews holds a BA in biology from Harvard University and an MD from Yale University School of Medicine, and previously served on the clinical faculty at Harvard Medical School and Brigham and Women's Hospital.

Catalyst Pharmaceuticals (CPRX) reported exceptional Q1 2025 financial results with total revenues reaching $141.4 million, representing a 43.6% year-over-year increase. The company's portfolio showed strong performance across all products: FIRDAPSE revenue grew 25.3% to $83.7M, AGAMREE generated $22.0M, and FYCOMPA contributed $35.6M (+17.1% YoY). GAAP net income surged 143.8% to $56.7M. The company maintains a robust financial position with $580.7M in cash and no debt. Catalyst reaffirmed its full-year 2025 revenue guidance of $545-565M, demonstrating confidence in continued growth. Key developments include Health Canada's acceptance of AGAMREE's New Drug Submission and a settlement with Teva regarding FIRDAPSE patent litigation, securing market exclusivity until February 2035.

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.