Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals Inc. develops and commercializes biotechnology medicines for serious diseases across eye disease, allergic and inflammatory conditions, cancer, cardiovascular and metabolic disease, neurological disease, hematologic conditions, infectious disease and rare disease. News about REGN commonly covers marketed products and pipeline programs such as EYLEA, EYLEA HD, Dupixent, Praluent, Libtayo, Kevzara, Otarmeni and investigational therapies developed through antibody, genetic medicine and RNA-based approaches.
Recurring company updates include financial results, FDA and European regulatory approvals, clinical trial data, label expansions, collaboration and licensing activity, product-access and pricing arrangements, share repurchase authorizations and corporate responsibility recognition. Regeneron's disclosures also frequently address its Sanofi collaboration around Dupixent and its use of proprietary technologies such as VelocImmune in drug discovery.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the initiation of late-stage clinical trials for REGN-COV2, an investigational antibody cocktail aimed at treating and preventing COVID-19. A Phase 3 trial will focus on uninfected individuals with close exposure to COVID-19 patients, enrolling 2,000 participants. Additionally, two adaptive Phase 2/3 trials will evaluate the treatment's effectiveness in hospitalized and non-hospitalized patients, expecting preliminary data later this summer. Regeneron collaborates with NIAID to expedite this dual-antibody initiative.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced the termination of the U.S. Phase 3 trial for Kevzara® (sarilumab) in COVID-19 patients on mechanical ventilation, as it failed to meet primary and key secondary endpoints. While minor positive trends were noted in critically ill patients on mechanical ventilation, these were not statistically significant and were offset by negative trends in patients not on mechanical ventilation. Adverse events were reported in 80% of Kevzara patients. Future details will be submitted for peer review, and a separate trial led by Sanofi is ongoing outside the U.S.
Regeneron Pharmaceuticals announced significant findings in a recent Science Translational Medicine publication regarding its CD28 costimulatory bispecific antibodies combined with Libtayo® (cemiplimab). This combination demonstrated enhanced anti-tumor activity, overcoming resistance to anti-PD-1 monotherapy and promoting long-term T-cell memory in preclinical models. Regeneron intends to initiate clinical trials for three different CD28 bispecifics by the end of 2020, with the first trial already underway for prostate cancer using REGN5678.
The FDA has approved a new 300 mg single-dose pre-filled pen for Dupixent (dupilumab), enhancing treatment accessibility for adults and adolescents aged 12 and older with chronic type 2 inflammatory diseases, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. This user-friendly pen, featuring hidden needle technology and audio-visual feedback, will be available in Q3 2020. Regeneron and Sanofi continue to collaborate with the FDA for the 200 mg version, while ensuring support through their DUPIXENT MyWay program, impacting over 150,000 patients globally.
Regeneron Pharmaceuticals and Sanofi announced the approval of Dupixent in China for treating moderate-to-severe atopic dermatitis in adults, addressing the urgent clinical need for new therapies. Recognized as an urgently needed overseas medicine, Dupixent is already approved in 60 countries and has transformed treatment by targeting type 2 inflammation. This approval follows data from a global clinical trial involving nearly 3,000 patients, showing positive safety and efficacy results. The launch aligns with Sanofi's growth strategy in China, with plans for more innovative medicines by 2025.