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 (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.
Regeneron Pharmaceuticals reported a 31% decline in Q4 2022 revenues, totaling $3.41 billion, and a 24% decrease for the full year 2022, at $12.17 billion. Excluding REGEN-COV and Ronapreve, Q4 revenues rose 14%. Notable product performance included EYLEA U.S. net sales dropping 3% but increasing 8% for the year, while Dupixent showed strong growth with a 38% quarterly rise. The company allocated $3.4 billion for business development and share repurchases in 2022. A new $3.0 billion share repurchase program was approved in January 2023. Meanwhile, the FDA accepted a BLA for aflibercept 8 mg aimed at treating wet AMD.
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Regeneron Pharmaceuticals and Sanofi announce that Dupixent has received European Commission approval for the treatment of eosinophilic esophagitis (EoE) in patients aged 12 and older. Dupixent is now the first targeted medicine available for this chronic inflammatory disease in the EU. In pivotal trials, 60% of patients treated with Dupixent experienced histological remission, significantly improving their swallowing abilities. The treatment shows potential in addressing other conditions related to type 2 inflammation. The safety profile remained consistent, with common side effects including injection site reactions and infections.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Dupixent® (dupilumab), recommending its approval to treat severe atopic dermatitis in children aged 6 months to 5 years. This decision is based on a successful Phase 3 trial showing Dupixent significantly improved skin clearance and reduced disease severity. Currently, about 80,000 children in Europe could benefit from this treatment. The final decision from the European Commission is pending.
On January 24, 2023, Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the finalists of the Regeneron Science Talent Search 2023, recognizing 40 high school seniors for their innovative scientific research. This prestigious competition, celebrating its 82nd year, awards over $1.8 million in prizes, with top awards reaching $250,000. The finalists, chosen from over 1,900 applicants, represent diverse scientific disciplines and address pressing societal issues such as climate change, public health, and social justice. The competition includes a rigorous judging process and culminates in an awards ceremony on March 14, 2023.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the date for its fourth quarter and full year 2022 financial results. The report will be released on February 3, 2023, prior to the U.S. market opening. A conference call and webcast to discuss the results will take place at 8:30 AM Eastern Time on the same day. Participants can join via the company's website or register for phone access. Regeneron focuses on developing innovative medicines, with a strong pipeline aimed at various serious diseases.