Regeneron Pharmaceuticals - REGN STOCK NEWS

Regeneron Pharmaceuticals announced that Dupixent (dupilumab) received European Commission approval for treating severe atopic dermatitis in children aged 6 months to 5 years. This makes Dupixent the first targeted therapy for this age group in Europe. The approval follows a Phase 3 trial showing significant improvements: 46% of children treated with Dupixent achieved a 75% reduction in disease severity, and 14% experienced clear or almost clear skin at 16 weeks. The treatment is noted for rapid itch reduction and sustained efficacy over one year. Dupixent is already used by over 600,000 patients globally.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi have shared promising results from a clinical trial of Dupixent (dupilumab) for adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first focusing on this hard-to-treat condition, achieved both primary and secondary endpoints. Key findings include that 40% of patients on Dupixent achieved clear or almost clear skin at 16 weeks compared to 17% on placebo. Additionally, 52% reported significant itch reduction versus 14% with placebo. Overall safety data mirrored Dupixent's established profile, indicating solid efficacy and safety outcomes for patients.

Regeneron Pharmaceuticals (NASDAQ: REGN) awarded Neel Moudgal, 17, from Saline, Mich., the $250,000 top award in the 2023 Regeneron Science Talent Search, the nation’s most prestigious science competition for high school seniors. Moudgal's project focused on developing a computer model for RNA structure prediction, facilitating disease diagnosis and treatment. The competition, in its 82nd year, awarded a total of $1.8 million to 40 finalists who excelled in scientific rigor and innovation. Regeneron aims to inspire future generations in STEM, with a commitment to promoting science education.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) aimed at treating adults and adolescents with chronic spontaneous urticaria (CSU) inadequately controlled by antihistamines. The FDA's target action date is October 22, 2023. CSU affects over 300,000 people in the U.S., with up to 50% remaining uncontrolled by standard treatment. The sBLA is based on data from two Phase 3 trials, LIBERTY-CUPID A and B, further confirming Dupixent's efficacy in this indication, currently under clinical development.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Kevzara (sarilumab) for treating polymyalgia rheumatica (PMR) in adults who cannot tolerate corticosteroid tapering. This approval follows the SAPHYR Phase 3 trial, where 28% of patients treated with Kevzara achieved sustained remission compared to 10% with placebo (p=0.0193). PMR, affecting adults over 50, causes significant pain and fatigue. Kevzara is now the first FDA-approved biologic therapy for PMR, providing a crucial treatment option for patients reliant on long-term steroid therapy. Regeneron highlighted its commitment to patient access through KevzaraConnect services.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced a positive opinion from the European Medicines Agency's CHMP recommending the approval of Libtayo (cemiplimab) in combination with platinum-based chemotherapy for adults with advanced non-small cell lung cancer (NSCLC) expressing ≥1% PD-L1. This decision is based on the Phase 3 EMPOWER-Lung 3 trial, which demonstrated a 22-month median overall survival (OS) for patients receiving Libtayo compared to 13-month for chemotherapy alone, representing a 45% reduction in death risk. The European Commission's final decision is awaited in the coming months, following the FDA's prior approval for Libtayo.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted its Biologics License Application (BLA) for aflibercept 8 mg, targeting wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The FDA's target action date is set for June 27, 2023. The BLA is backed by two pivotal trials indicating non-inferior vision gains compared to EYLEA, with high patient retention rates for dosing regimens over 48 weeks. Aflibercept 8 mg is developed jointly with Bayer AG, holding exclusive marketing rights in the U.S.

Regeneron Pharmaceuticals announced that the FDA has accepted for Priority Review the Biologics License Application for pozelimab as a treatment for CHAPLE, a rare hereditary immune disease. CHAPLE, affecting fewer than 100 patients globally, causes dangerous symptoms due to complement system overactivation. Pozelimab, a monoclonal antibody targeting complement factor C5, showed positive results in a Phase 2/3 trial, with 100% of participants achieving significant symptom improvement by 24 weeks. The FDA's decision is expected by August 20, 2023, and if approved, pozelimab would be the only treatment for CHAPLE.

Regeneron Pharmaceuticals has received FDA approval for EYLEA^® (aflibercept) Injection to treat retinopathy of prematurity (ROP) in preterm infants, marking its first pediatric approval. This decision expands EYLEA's indications to five retinal conditions linked to ocular angiogenesis. Each year, 1,100 to 1,500 infants in the U.S. develop severe ROP requiring treatment. The approval is based on data from two Phase 3 trials where around 80% of EYLEA-treated infants showed significant improvements. Regeneron's collaboration with Bayer continues in the global development of EYLEA, which maintains exclusive rights in the U.S.