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 (Nasdaq: CPRX) has received a Notice of Allowance for U.S. Patent Application Serial Number 14/128,672 from the USPTO. This patent covers methods for treating patients with certain mutations using 3,4-Diaminopyridine (3,4-DAP). The expected patent issuance will protect Catalyst's Firdapse® franchise until at least June 29, 2032, with potential extensions. The company plans to list this patent in the FDA's "Orange Book," blocking generic competition unless challenged. This development supports Catalyst's ongoing research and product expansion in neuromuscular disease therapies.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported second quarter 2020 net revenues of $29.6 million, up from $28.8 million in Q2 2019. Net income was $9.8 million or $0.09 per share. The company received Health Canada marketing authorization for Firdapse® for LEMS treatment. However, the Phase 3 trial for anti-MuSK-MG did not achieve statistical significance for primary or secondary endpoints. Catalyst ended the quarter with $115.1 million in cash and no debt, while continuing various clinical development programs and expansion efforts in Canada and Japan.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced Health Canada’s approval of Firdapse® (amifampridine) for treating Lambert-Eaton myasthenic syndrome (LEMS), a rare neurodegenerative condition. The approval was granted under Priority Review based on data from two multinational clinical trials. Firdapse® was previously approved in the U.S. and Europe. Catalyst is exploring partnerships for distribution in Canada and aims to expand Firdapse® indications. LEMS is often linked to autoimmune disorders and can be life-threatening.
Catalyst Pharmaceuticals (Nasdaq: CPRX) has transitioned its 2020 Annual Meeting of Stockholders to a virtual-only format due to the COVID-19 pandemic. The meeting is scheduled for August 20, 2020, at 9:00 AM ET. Stockholders can participate in voting and submitting questions via an online platform. Only those registered by June 22, 2020, can attend. The company has provided detailed instructions for both registered and street name stockholders to register for the meeting. Additionally, the Proxy Statement and related information are available on their website.
Catalyst Pharmaceuticals (Nasdaq: CPRX) will release its Q2 2020 financial results after market close on August 10, 2020. An investment-community conference call is scheduled for August 11, 2020, at 8:30 a.m. ET to discuss the results and provide a corporate update. Investors can participate by calling (877) 407-8912 for domestic and (201) 689-8059 for international callers, or stream via the company's website. A webcast replay will be available for 30 days post-call.
Catalyst Pharmaceuticals (CPRX) announced a disappointing recommendation from a Magistrate Judge regarding its lawsuit against the FDA, advising to deny Catalyst's motion for summary judgment. The recommendation, which Catalyst believes is legally flawed, could jeopardize the exclusivity benefits of the Orphan Drug Act. Chairman Patrick J. McEnany stated that if upheld, the decision could discourage investment in orphan drug development. Despite this setback, Catalyst remains committed to protecting its drug Firdapse® from competition.
Catalyst Pharmaceuticals (Nasdaq: CPRX) announced several leadership promotions, including Jeffrey Del Carmen to Chief Commercial Officer. Del Carmen, who previously served as Senior Vice President of Sales and Marketing, will lead efforts to expand access to the company's Firdapse product for Lambert-Eaton myasthenic syndrome (LEMS) and prepare for a potential launch for anti-MuSK antibody positive myasthenia gravis. The company also promoted Pete Curry to Vice President of Sales and Maria Pandolfo to Vice President of Patient Services.
Catalyst Pharmaceuticals, focused on rare neuromuscular diseases, announced its presentation at the Jefferies Virtual Healthcare Conference on June 2-4, 2020. CEO Patrick J. McEnany and CSO Steven Miller will host one-on-one investor meetings, with their presentation on June 4 at 8:30 a.m. E.T. The event will be accessible via the company's investor webpage. Catalyst's Firdapse® (amifampridine) is FDA-approved for Lambert-Eaton myasthenic syndrome and is under evaluation for other conditions. The press release emphasizes Catalyst's commitment to innovative therapies.
Catalyst Pharmaceuticals (Nasdaq: CPRX) reported Q1 2020 net revenues of $29.1 million, a 134% increase from the previous year. The company achieved a GAAP net income of $10.4 million or $0.10 per share, compared to a loss of $645,000 in Q1 2019. Catalyst withdrew its 2020 revenue guidance due to COVID-19 uncertainties while highlighting minimal impact on Q1 revenues. The firm ended the quarter with $101.8 million in cash and no debt and expanded its sales force to enhance the Firdapse franchise. Upcoming milestones include Phase 3 trial results for MuSK-MG expected in Q3 2020.
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