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 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 (p<0.0001). 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.
Regeneron (REGN) and Alnylam (ALNY) announced positive preliminary data from a Phase 1 study of ALN-HSD, aimed at treating nonalcoholic steatohepatitis (NASH). Results show robust target knockdown and lower liver enzymes in patients receiving ALN-HSD compared to placebo, with a favorable safety profile. The companies plan to advance to a Phase 2 trial in late 2022. The study highlighted a significant unmet need in NASH, which affects 16 million people in the U.S. and is projected to be a leading cause of liver transplants.
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.
Positive clinical data from a Phase 2 trial of Libtayo (cemiplimab) show a 63.3% combined pathologic response rate in patients with stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The trial involved 79 patients, with a 68% objective response rate. The findings were presented at the ESMO Congress 2022 and published in the New England Journal of Medicine. Adverse events were reported in 87% of patients; however, serious events were only 17%. Follow-up studies are ongoing, assessing potential impacts on disease-free survival.