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. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
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.
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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.
Regeneron Pharmaceuticals (REGN) announced key findings from its oncology pipeline at the ESMO IO Congress 2022 in Geneva. The results included initial data on the investigational combination of fianlimab and Libtayo in treating advanced non-small cell lung cancer (NSCLC). The Phase 1 trials indicated a 27% objective response rate in anti-PD-1/PD-L1-naïve patients and a 7% rate in experienced patients, demonstrating potential therapeutic benefits. Safety assessments showed adverse events but no treatment-related deaths. Additional presentations include analyses on melanoma and cervical cancer.
Regeneron Pharmaceuticals, Inc. (REGN) has announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Evkeeza® (evinacumab-dgnb) under Priority Review. This would establish Evkeeza as the first treatment for children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). This condition affects 1,300 patients in the U.S. The trial indicated a significant average LDL-C reduction of 48% after 24 weeks of treatment. The FDA decision is expected by March 30, 2023.
Regeneron Pharmaceuticals announced the European Commission's approval of Libtayo (cemiplimab) for adult patients with recurrent or metastatic cervical cancer after platinum-based chemotherapy. This decision follows positive results from the Phase 3 EMPOWER-Cervical 1 trial, which demonstrated a 31% reduction in the risk of death compared to chemotherapy. Libtayo is now approved for four cancer types in the EU, marking a significant milestone in treatment options for advanced cervical cancer, which affects approximately 600,000 new cases globally each year.
Regeneron Pharmaceuticals and CytomX Therapeutics have entered a significant collaboration to develop next-generation bispecific immunotherapies. CytomX will receive an upfront payment of $30 million and could earn up to $2 billion in future milestones. The collaboration focuses on utilizing CytomX's Probody® technology and Regeneron's Veloci-Bi® platform to create therapies that activate specifically in tumor environments, potentially improving treatment efficacy and reducing side effects. The partnership aims to expand cancer treatment options significantly.