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 (CPRX) announced a new patent for Firdapse® (amifampridine) Tablets, U.S. Patent No. 11,060,128, enhancing its intellectual property protection. This patent addresses innovative dosing methods for slow metabolizers of amifampridine, particularly in treating Lambert-Eaton myasthenic syndrome (LEMS). Catalyst is pursuing additional patents, optimistic about their approval. The company aims to support the neuromuscular community and is investigating Firdapse® for other rare diseases, alongside ongoing clinical trials for myasthenia gravis.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has appointed Dr. Preethi Sundaram as the Chief Product Development Officer. Dr. Sundaram brings over 20 years of experience in product development, having held various leadership roles at Sanofi and other companies. In this newly created position, she will oversee Catalyst's product pipeline, focusing on therapies for rare diseases. The company aims to enhance its R&D strategy and expedite the development of innovative treatment options. Catalyst's FDA-approved drug Firdapse® is already on the market for LEMS, with ongoing clinical trials for MuSK-MG.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced the appointment of Molly Harper to its Board of Directors. Harper brings over 20 years of experience in life sciences, specializing in rare disease drug development and commercialization. Currently, she serves as Executive Vice President of Operations at Relmada Therapeutics and has held senior positions at Akcea Therapeutics and Sanofi Genzyme. The Board's chairman expressed confidence in her ability to strengthen the company's growth strategy as Catalyst focuses on expanding its portfolio of medicines for rare diseases.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) announced that Health Canada has re-issued a Notice of Compliance for Ruzurgi® (amifampridine), allowing it to be marketed for Lambert-Eaton Myasthenic Syndrome (LEMS) patients. This decision follows a prior court ruling that quashed the original NOC. CEO Patrick McEnany expressed disappointment over the decision, which affects their market opportunity in Canada. Catalyst and KYE Pharmaceuticals are considering legal action to challenge this ruling, as it does not honor the data protection rights they hold under Canadian law.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has entered an exclusive license and supply agreement with DyDo Pharma for the development and commercialization of Firdapse® (amifampridine) in Japan, targeting Lambert-Eaton myasthenic syndrome (LEMS). DyDo Pharma will fund all related activities and hold exclusive commercialization rights in Japan, while Catalyst will oversee supply and provide support for regulatory approval. Catalyst will receive an upfront payment and potential milestones. The partnership aims to address the unmet medical needs for LEMS in Japan.
Catalyst Pharmaceuticals (CPRX) announced a significant ruling from the Canadian Federal Court, which has quashed the Notice of Compliance for Ruzurgi® previously granted by Health Canada. This decision emphasizes the protection of Firdapse®'s data exclusivity, allowing a review of Ruzurgi®'s marketing authorization. As a result, Ruzurgi® currently lacks marketing authorization in Canada, impacting its commercial prospects. The ruling highlights the ongoing complexities in drug submissions and the importance of adhering to data protection regulations.
Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX) announced participation in two investor conferences. The Oppenheimer Rare & Orphan Disease Summit will feature Catalyst’s pre-recorded presentation on May 21, 2021, at 8:00 a.m. EDT, followed by virtual meetings. The Jefferies Virtual Healthcare Conference will see Catalyst present on June 2, 2021, at 4:00 p.m. EDT, with additional virtual meetings throughout the day. Catalyst specializes in developing high-quality medicines for rare diseases and seeks to expand its pipeline, notably with Firdapse® for LEMS.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported Q1 2021 net revenues of $30.2 million, up from $29.1 million in Q1 2020. GAAP net income was $7.7 million ($0.07 per share), a decrease from $10.4 million ($0.10 per share) in the same period last year. The company has $143.3 million in cash and no funded debt. Catalyst recently received Orphan Drug Designation for Firdapse® in Japan. The firm plans to expand investments in R&D and other therapeutic areas, aligning with its new strategic focus. A conference call is scheduled for May 11, 2021, to discuss further details.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q1 2021 financial results after market close on May 10, 2021. A conference call is scheduled for May 11, 2021, at 8:30 a.m. ET to discuss the results and provide corporate updates. Catalyst focuses on developing high-quality medicines for rare diseases, with Firdapse® (amifampridine) currently being evaluated for MuSK-MG and recently approved in Canada for LEMS. The company is committed to a robust pipeline of medicines and maintains transparency regarding known risks in its forward-looking statements.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced a share repurchase program, authorizing the buyback of up to $40 million of its outstanding common stock. This move signifies the company's confidence in its long-term outlook and strong cash flow generation capabilities.
CEO Patrick J. McEnany emphasized the robust balance sheet and earnings potential that position Catalyst well for its strategic initiatives and shareholder value enhancement. The buyback will utilize existing cash, with purchases made at management's discretion based on market conditions.
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