Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) received marketing and manufacturing authorization from Japan's Ministry of Health for Libtayo^® (cemiplimab), marking it as the first approved monotherapy for advanced cervical cancer in the country. This approval follows positive results from the Phase 3 EMPOWER-Cervical 1 trial, which showed significant survival benefits compared to chemotherapy. The global incidence of cervical cancer is rising, with about 600,000 new cases and 350,000 deaths each year. Libtayo was previously approved in the EU for similar indications.

Regeneron Pharmaceuticals and Sanofi announced that a Phase 3 trial of Dupixent (dupilumab) 300 mg weekly for treating eosinophilic esophagitis (EoE) showed significant improvements in patient histology and symptoms compared to placebo. Improvements were sustained for up to one year in patients aged 12 and older. Dupixent is the first U.S. approved targeted treatment for EoE. The FDA approved Dupixent in May 2022, and the EMA has given a positive opinion for its use in Europe. Safety results matched Dupixent's known profile, suggesting a favorable risk-benefit ratio.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that it will webcast its presentation at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:00 a.m. Pacific Time. Investors can access the presentation via the company's website, with an archived version available for 30 days thereafter. Regeneron, a leading biotechnology firm founded by physician-scientists, develops innovative medicines for serious diseases across various therapeutic areas including eye diseases, cancer, and rare conditions.

Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's Committee has recommended Dupixent for approval to treat adolescents and adults aged 12 and over with eosinophilic esophagitis (EoE). This would make Dupixent the first targeted treatment for EoE in the EU, following its U.S. approval in May 2022. The positive recommendation is based on pivotal trial data showing significant improvements in patients' ability to swallow and histological remission. The European Commission will make a final decision soon.

Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved Dupixent (dupilumab) for treating adults with moderate-to-severe prurigo nodularis, marking it the first targeted medicine for this condition in Europe. Clinical trials showed that 60% of Dupixent patients experienced significant itch reduction at 24 weeks, compared to 18% for placebo. The drug also improved skin lesions and overall quality of life. Approximately 70,000 adults in Europe are affected by this chronic skin disease, underscoring the need for effective treatment options.

Regeneron's Phase 2 trial data for odronextamab in relapsed/refractory follicular lymphoma revealed an impressive 82% response rate among patients, with 75% achieving complete responses. The median progression-free survival was reported at 20 months, while overall survival remains not reached. These outcomes are critical for anticipated regulatory submissions in 2023, including to the FDA. The study involved 121 patients, all of whom had undergone prior treatments. Safety evaluations noted adverse events mostly of grade 3 or higher, with cytokine release syndrome being common.

Regeneron Pharmaceuticals announced initial positive data from a pivotal Phase 2 trial for linvoseltamab (200 mg dose) at the ASH Annual Meeting. The trial included patients with high disease burden, showing a 64% response rate and 45% achieving very good partial responses. With a median follow-up of 3 months, results suggest ongoing efficacy and safety. Notably, 95% of patients reported adverse events, with 66% being severe. The complete dataset is under evaluation as the drug aims to address unmet needs in relapsed/refractory multiple myeloma.

Regeneron Pharmaceuticals (REGN) announced promising results from a Phase 1 and pivotal Phase 2 trial of odronextamab, showing a 49% objective response rate (ORR) in CAR-T naive patients, with 31% achieving a complete response (CR). In patients post-CAR-T therapy, an ORR of 48% and 32% CR were noted. Data will support regulatory submissions planned for 2023. The ongoing trials include ELM-1 and ELM-2, focusing on treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Adverse events were reported in 99% of patients, but no Grade 4 or 5 cytokine release syndrome cases were observed.