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 reports developments as a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing medicines for rare and difficult-to-treat diseases. Its recurring updates center on the commercial performance of FIRDAPSE® (amifampridine), AGAMREE® (vamorolone), and FYCOMPA® (perampanel), along with financial results, revenue guidance, conference presentations, and business updates.
Company news also covers product-specific medical and legal developments, including vamorolone research in Duchenne muscular dystrophy and patent litigation settlements involving FIRDAPSE. Additional announcements address patient advocacy initiatives, support services, and strategic portfolio activity tied to Catalyst’s U.S.-based rare-disease commercial model.
Catalyst Pharmaceuticals (NASDAQ: CPRX) announced it received a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals, which seeks FDA authorization for a generic version of FIRDAPSE®.
Teva's ANDA asserts that Catalyst's patents are invalid or not infringed. Catalyst must respond within 45 days to potentially trigger a legal battle that could delay Teva's market entry until May 2026.
Catalyst is committed to enforcing its intellectual property rights regarding FIRDAPSE®, which is used to treat Lambert-Eaton myasthenic syndrome.
Catalyst Pharmaceuticals has announced its acquisition of the U.S. rights for FYCOMPA® (perampanel) from Eisai Co., Ltd for $160 million. The acquisition, expected to close in early 2023, will enhance Catalyst's neurology portfolio, adding a well-established product with projected net revenues of approximately $136 million for Eisai’s fiscal 2022. Additionally, an exclusive option period to evaluate a rare epilepsy compound from Eisai's pipeline is included. Catalyst anticipates that this deal will be accretive to both EBITDA and EPS in 2023.
Catalyst Pharmaceuticals (CPRX) reported a record Q3 2022 net revenue of $57.2 million, a 59.3% increase year-over-year. The company raised its full-year revenue guidance to $205-210 million. Q3 GAAP net income reached $22.7 million ($0.22 per basic share), influenced by a one-time acquisition charge of $4.1 million. Non-GAAP net income also rose to $28.6 million. Cash and investments grew to $256.1 million. Catalyst achieved important milestones, including FDA approval for pediatric use of FIRDAPSE® and the acquisition of Ruzurgi®.
Catalyst Pharmaceuticals (CPRX) has been honored with the 2022 David J. Gury Company of the Year award by BioFlorida, recognizing its significant contributions to the life sciences sector in Florida. The company is celebrated for its innovative treatment, FIRDAPSE®, aimed at patients suffering from Lambert-Eaton Myasthenic Syndrome (LEMS). Catalyst's commitment to addressing unmet medical needs underpins its mission, according to CEO Patrick J. McEnany. The award highlights Catalyst's efforts in improving patient access to essential therapies.
Catalyst Pharmaceuticals (CPRX) will release its third quarter 2022 financial results on November 9, 2022, after market close. A subsequent conference call and webcast will occur on November 10, 2022, at 8:30 AM ET, where the management team will discuss the results and provide a corporate update. FIRDAPSE®, approved in 2018, is available for treating adults and children with Lambert-Eaton myasthenic syndrome in the U.S. and Canada. Forward-looking statements highlight potential risks that may affect results significantly.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced FDA approval for FIRDAPSE® (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS) in patients aged six years and older. This expands the treatment option for pediatric patients, addressing a significant need within a small patient population. FIRDAPSE was previously approved for adults in the U.S. and Canada. The company is committed to ensuring access through its Catalyst Pathways program, which provides support for qualifying patients.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that Patrick J. McEnany, Chairman and CEO, and the management team will attend the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. An on-demand presentation will be accessible to registered attendees on September 12 at 7:00 AM Eastern Time via the conference portal. Additionally, the presentation will be available on Catalyst's website. The company specializes in developing novel medicines for rare diseases, notably with FDA-approved FIRDAPSE® for Lambert-Eaton myasthenic syndrome.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced its participation in Citi's 17th Annual BioPharma Conference on September 7-8, 2022. Chairman and CEO Patrick J. McEnany, along with the management team, will host one-on-one meetings on September 8. Catalyst is dedicated to developing and commercializing innovative medicines for rare diseases, including its recently FDA-approved drug FIRDAPSE® for Lambert-Eaton myasthenic syndrome.
FIRDAPSE is also approved for use in Canada, showcasing Catalyst's commitment to addressing unmet medical needs in rare diseases.
Catalyst Pharmaceuticals (CPRX) reported record Q2 2022 net product revenues of $53.0 million, marking a 57.7% year-over-year increase. Cash and short-term investments totaled $220.8 million with no funded debt. The company completed the acquisition of Ruzurgi® U.S. and Mexico rights, potentially extending FIRDAPSE patent protection to 2037. Catalyst forecasts full-year adjusted EBITDA between $100-105 million and expects total revenues between $195-205 million, reflecting a 38%-45% increase from 2021.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q2 2022 financial results after market close on August 9, 2022. A conference call and webcast are scheduled for August 10, 2022, at 8:30 AM ET, where management will discuss the results and provide a corporate update. The event can be accessed via the company's website, and a replay will be available for 30 days. Catalyst focuses on developing medicines for rare diseases, with its FDA-approved product FIRDAPSE® for Lambert-Eaton myasthenic syndrome.