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 commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing medicines for patients living with rare and difficult-to-treat diseases. The CPRX news feed on Stock Titan aggregates company announcements, financial updates, scientific disclosures, and investor conference appearances drawn from Catalyst’s own public communications and regulatory filings.
Readers can find earnings and financial result announcements, where Catalyst reports product revenue contributions from FIRDAPSE, AGAMREE, and FYCOMPA, along with commentary on operating performance and business outlook. These releases often discuss factors such as organic growth in Lambert-Eaton myasthenic syndrome markets, demand in Duchenne muscular dystrophy centers of excellence, and the impact of generic competition on specific products.
The news stream also features corporate and strategic updates, including authorization of share repurchase programs, patent litigation settlements related to FIRDAPSE, and developments in clinical practice guidelines that reference conditions and therapies linked to the company’s portfolio. In addition, Catalyst regularly announces participation in major healthcare and investor conferences, providing insight into how management presents the story behind CPRX to the investment community.
For those following the scientific and patient-focused side of the business, the news includes conference presentations and advocacy initiatives, such as real-world analyses in Duchenne muscular dystrophy, research on Lambert-Eaton myasthenic syndrome, and programs like the Catalyst Advocacy Scholars Summit with academic partners. Investors, analysts, and patients can use this page to monitor how Catalyst’s rare disease strategy, clinical activities, and capital allocation decisions evolve over time. Bookmark this CPRX news page for a centralized view of the company’s key public announcements.
Catalyst Pharmaceuticals (CPRX) reported a Q2 2021 total net revenue of $36.4 million, up 23% year-over-year, driven by Firdapse® product sales of $33.6 million. The GAAP net income was $12.2 million, or $0.12 per share, an improvement from $9.8 million in Q2 2020. Catalyst holds $155.3 million in cash with no funded debt. The company aims to enhance its operational portfolio and commercialization efforts, evidenced by recent leadership expansions and partnerships, including an exclusive agreement with DyDo Pharma for Firdapse® in Japan.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its second quarter 2021 financial results on August 9, 2021, after market close. An investment-community conference call is scheduled for August 10, 2021, at 8:30 a.m. ET to discuss these results and provide a corporate update. Investors can participate either by phone or by listening online through the company’s website.
With a focus on rare diseases, Catalyst continues its commitment to developing high-quality medicines, including Firdapse®, which is already approved for LEMS treatment in the U.S. and Canada.
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.