Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals (REGN) announced that it will present new data at the 2022 American Society of Hematology (ASH) Annual Meeting from December 10-13 in New Orleans. Key highlights include Phase 2 data for odronextamab (CD20xCD3) in relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma and updated data for linvoseltamab (REGN5458) in multiple myeloma. An investor webcast is scheduled for December 14 at 8:30 AM ET to discuss the hematology portfolio further.

Regeneron Pharmaceuticals reported a 15% decrease in Q3 2022 revenues, totaling $2.94 billion, largely due to no sales from REGEN-COV. However, excluding this, revenues grew 11%. EYLEA's U.S. sales reached a record $1.63 billion, and Dupixent global sales rose 40% to $2.33 billion. GAAP diluted EPS was $11.66, down 19% from the previous year. Positive trial results for aflibercept 8 mg in diabetic macular edema and wet AMD were also announced. The FDA extended EYLEA's exclusivity by six months.

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.