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. (symbol: REGN) is a prominent American biotechnology company headquartered in Westchester County, New York, since its founding in 1988. The core mission of Regeneron is to discover, develop, and commercialize innovative products targeting a range of serious medical conditions. With a diverse portfolio, Regeneron focuses on therapies for eye diseases, cardiovascular conditions, cancer, and inflammatory disorders.
Among its marketed products, Eylea stands out as a treatment for wet age-related macular degeneration and other eye diseases. Praluent is designed to lower LDL cholesterol levels, while Dupixent addresses multiple immunological conditions. In the oncology sector, Libtayo is a key therapy, and Kevzara targets rheumatoid arthritis.
The company is also heavily invested in the development of monoclonal and bispecific antibodies, often in collaboration with Sanofi and other partners. These initiatives include cutting-edge technologies such as RNA interference (RNAi) with Alnylam and CRISPR-based gene editing with Intellia.
Regeneron's recent progress includes significant advancements in its clinical-stage pipeline, which comprises over 35 product candidates. The company's financial health remains robust, supported by strong revenue streams from collaboration with Sanofi and a strategic $3.0 billion share repurchase program authorized by the board.
Latest updates highlight the company's ongoing efforts in gene therapy, particularly in treating genetic deafness and solid tumors. Regeneron's commitment to pioneering genetic medicine and leveraging data insights from the Regeneron Genetics Center® positions it as a leader in the biopharmaceutical industry.
For more information, visit Regeneron Pharmaceuticals.
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.
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