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 and Sanofi announced that Libtayo® (cemiplimab) demonstrated superior overall survival compared to chemotherapy in advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The Lancet published these pivotal trial results, which support regulatory submissions in the U.S. and EU. The FDA has granted a Priority Review with a target action date of February 28, 2021. Libtayo reduced the risk of death by 32% overall and 43% in high PD-L1 expressers. Safety profiles were consistent, with higher immune-mediated adverse events in the Libtayo group.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the U.S. Court of Appeals upheld a previous ruling invalidating Amgen's patent claims on PCSK9 antibodies, benefiting Regeneron's Praluent. This decision confirms that Amgen's patents were overly broad and validates Regeneron's proprietary technology in developing Praluent. This ruling follows a similar decision by the European Patent Office. Regeneron maintains exclusive rights to Praluent in the U.S., while Sanofi holds rights outside the U.S. Praluent is approved in over 60 countries to lower LDL cholesterol and reduce heart attack risks.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA approval of Evkeeza (evinacumab-dgnb) for treating homozygous familial hypercholesterolemia (HoFH) in patients aged 12 and older. Evkeeza, the first ANGPTL3 inhibitor approved, reduced LDL-C levels by nearly 50% in a pivotal Phase 3 trial. The average annual cost is projected at $450,000. Regeneron also offers financial support through the myRARE™ program, aiming to ease access for eligible patients. This approval marks a significant milestone for patients suffering from this ultra-rare condition.
Regeneron and Sanofi announced FDA approvals for Libtayo® (cemiplimab-rwlc), the first immunotherapy for advanced basal cell carcinoma (BCC). The treatment received full approval for locally advanced BCC and accelerated approval for metastatic BCC. This marks a pivotal advancement for patients who progress on hedgehog pathway inhibitors. In clinical trials, Libtayo demonstrated a 21% overall response rate in metastatic BCC and 29% in locally advanced BCC. Adverse reactions were reported in 32% of patients, underscoring the need for monitoring during treatment.
Regeneron Pharmaceuticals (REGN) reported a 30% revenue increase to $2.42 billion in Q4 2020, with EYLEA® U.S. net sales at $1.34 billion (+10%) and Dupixent® global sales at $1.17 billion (+56%). GAAP diluted EPS rose 48% to $10.24. The REGEN-COV™ antibody cocktail received FDA Emergency Use Authorization, with a new agreement for 1.25 million doses worth $2.625 billion. The company anticipates continued growth in 2021 through EYLEA, Dupixent, and Libtayo, with several regulatory reviews pending.
Regeneron Pharmaceuticals and Sanofi announced new analyses highlighting the efficacy of Dupixent® (dupilumab) in treating diseases driven by type 2 inflammation, including asthma, atopic dermatitis, eosinophilic esophagitis, and chronic rhinosinusitis with nasal polyposis. The results, to be presented at the AAAAI Virtual Annual Meeting from February 26 to March 1, demonstrate significant improvements in patients' symptoms across multiple studies. Dupixent, a fully-human monoclonal antibody, targets IL-4 and IL-13 signaling, vital in managing type 2 inflammatory diseases.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced confirmation from Columbia University researchers that its REGEN-COV antibody cocktail neutralizes SARS-CoV-2 variants from the UK and South Africa. Published data indicates REGEN-COV retains effectiveness against these variants, with further studies ongoing for additional mutations. The cocktail features two monoclonal antibodies, imdevimab and casirivimab, designed to block virus infectivity. Regeneron is enhancing global supply through collaboration with Roche and is prepared to develop new antibody combinations to combat future variants.
Regeneron Pharmaceuticals reported positive initial results from a Phase 3 trial of REGEN-COV, an antibody cocktail for preventing COVID-19. The study showed a 100% prevention rate of symptomatic infections in high-risk individuals, and a 50% reduction in overall infections compared to placebo. Infections in the treatment group were asymptomatic with markedly lower viral loads and shorter durations of shedding. Safety assessments indicated fewer adverse events with REGEN-COV, and the injection method offers greater convenience. Full Phase 3 results are expected early Q2 2021.
Regeneron Pharmaceuticals and the Society for Science have announced the 2021 finalists for the Regeneron Science Talent Search, recognizing 40 exceptional high school seniors from a pool of 1,760 entrants. These finalists, selected for their scientific projects, will compete for over $1.8 million in awards during a virtual event March 10-17, 2021. Notable projects include studies on COVID-19 diagnostics and e-cigarette impacts on COPD. Each finalist will receive at least $25,000, with top prizes reaching $250,000.
On January 21, 2021, Regeneron Pharmaceuticals (NASDAQ: REGN) and the Society for Science announced the finalists for the Regeneron Science Talent Search 2021, highlighting 40 outstanding high school seniors selected from 1,760 entrants. They will compete for over $1.8 million in awards during a virtual competition from March 10-17, 2021. Finalists’ projects cover diverse STEM fields, addressing critical issues such as COVID-19 diagnostics and environmental concerns. Each finalist receives at least $25,000, with top awards reaching $250,000. This initiative fosters innovation and encourages young scientists.