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 announces a positive opinion from the European Medicines Agency's CHMP for its drug Libtayo (cemiplimab) to treat advanced cervical cancer. This recommendation is based on the Phase 3 EMPOWER-Cervical 1 trial, which demonstrated a 31% reduction in death risk compared to chemotherapy. The trial included 608 patients, with Libtayo showing safety without new adverse effects. The European Commission will make a final approval decision in the upcoming months, potentially expanding Libtayo's application in oncology.
Regeneron Pharmaceuticals announced that the FDA has accepted its supplemental Biologics License Application for EYLEA (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants, with a decision due by February 11, 2023. ROP is a crucial cause of childhood blindness, affecting 1,100-1,500 infants annually in the U.S. The application is backed by two Phase 3 trials, which showed high efficacy rates, though it did not meet the primary endpoint of non-inferiority to laser treatment. Both studies reported consistent safety profiles for EYLEA. Regeneron maintains exclusive rights to EYLEA in the U.S.
Regeneron Pharmaceuticals and Sanofi reported positive results from a Phase 3 trial of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years. At week 16, up to 68% of children on a higher dose achieved significant disease remission, exceeding the 3% in the placebo group (p0.0001). The trial suggests Dupixent can improve esophageal damage and promote healthy weight gain in this vulnerable population. Safety data indicated similar adverse event rates compared to placebo, with common issues being mild and manageable. The data has been submitted to global regulatory authorities.
Regeneron Pharmaceuticals (NASDAQ: REGN) will announce its third quarter 2022 financial results on November 3, 2022, before the U.S. markets open. A conference call and webcast will be held at 8:30 AM Eastern Time on the same day. Participants can join via the company's 'Investors and Media' webpage or register for telephonic access. Regeneron is a biotech firm focused on developing life-changing medicines, with a strong pipeline aimed at treating various serious diseases.
Regeneron Pharmaceuticals (NASDAQ: REGN) has appointed Dr. Craig B. Thompson to its Board of Directors and the Technology Committee, expanding the board from 12 to 13 members. Dr. Thompson, former President and CEO of Memorial Sloan Kettering Cancer Center, brings expertise in immuno-oncology and precision medicine. His leadership led to significant advancements in cancer care and research. The board now includes eight National Academy of Sciences members, reflecting Regeneron's commitment to scientific excellence and innovation in developing transformative medicines.
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Regeneron Pharmaceuticals and Sanofi announced the FDA's approval of Dupixent (dupilumab) for treating prurigo nodularis in adults, marking it as the first approved therapy for this chronic skin condition. This decision impacts about 75,000 adults in the U.S. affected by prurigo nodularis, a disease characterized by severe itching and skin lesions. The approval followed positive outcomes from pivotal Phase 3 trials, where Dupixent demonstrated significant reductions in itch and skin lesions compared to placebo. Safety data were consistent with known profiles, with common adverse events including nasopharyngitis and conjunctivitis.
Intellia Therapeutics and Regeneron Pharmaceuticals announced promising interim results from the Phase 1 study of NTLA-2001, a CRISPR therapy for transthyretin (ATTR) amyloidosis. The trial exhibited significant mean serum transthyretin reductions of 93% and 92% at doses of 0.7 mg/kg and 1.0 mg/kg, respectively, on day 28. The treatment was well-tolerated, with minimal adverse reactions. Follow-ups indicated sustained reductions over two to six months. Intellia plans to expand the study with a fixed dose of 0.7 mg/kg and aims for a pivotal trial, potentially including U.S. patients.
Regeneron Pharmaceuticals and Sanofi announced the publication of significant Phase 3 trial results for Dupixent (dupilumab) in treating children aged 6 months to 5 years with uncontrolled atopic dermatitis. The study demonstrated that Dupixent, in combination with low-potency topical corticosteroids, improved skin clearance, reduced severity of disease, and lessened itch compared to placebo. Safety profiles were consistent with older children. The FDA approved Dupixent for this age group in June 2022, with further regulatory reviews ongoing in Europe.
Alnylam and Regeneron have released preliminary Phase 1 results for ALN-HSD, an RNAi therapeutic targeting HSD17B13, aimed at treating nonalcoholic steatohepatitis (NASH).
The study showed promising outcomes, with robust target knockdown and reduced liver enzymes over six months in 20 patients compared to 4 in the placebo group.
Following this success, a Phase 2 study is set to commence in late 2022. Safety data indicated mild injection site reactions, with no serious adverse events reported, further validating ALN-HSD's potential in addressing NASH's significant unmet medical needs.