Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals has secured pediatric exclusivity for its drug EYLEA (aflibercept) Injection from the FDA. This grant extends U.S. market exclusivity by six months until May 17, 2024. The decision stems from two Phase 3 trials—BUTTERFLEYE and FIREFLEYE—aimed at treating retinopathy of prematurity in preterm infants. EYLEA currently treats various eye conditions and has an established safety profile supported by extensive research. The collaboration with Bayer continues for global development.

Immune-Onc Therapeutics has initiated the first patient dosing in the Phase 1 study of IO-108, a myeloid checkpoint inhibitor, targeting solid tumors. The company has established a clinical supply agreement with Regeneron (NASDAQ: REGN) to evaluate IO-108 alongside Regeneron's Libtayo® (cemiplimab). IO-108 has shown promising activity in various tumor types and will be assessed in multiple expansion cohorts as both a monotherapy and in combination therapies. Immune-Onc retains global commercialization rights and is focused on combining its treatments with existing T-cell checkpoint therapies.

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 (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.

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.