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 (NASDAQ: REGN) and Sanofi announced positive Phase 3 results for Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial demonstrated significant reductions in severe asthma attacks and improved lung function. These findings support Dupixent's recent FDA approval for this patient group. The publication of results in the New England Journal of Medicine reinforces Dupixent's established safety profile, with 83% adverse event rates reported. Regulatory reviews for Dupixent in the EU are ongoing, with a decision expected in Q1 2022.
Regeneron Pharmaceuticals (NASDAQ: REGN) will participate in a virtual fireside chat at the H.C. Wainwright & Co. event on December 6, 2021, at 2:00 p.m. ET. Aris Baras, M.D., Senior Vice President and Head of the Regeneron Genetics Center, will represent the company. The session can be accessed via Regeneron's 'Investors & Media' page and will be archived for replay for at least 30 days. Regeneron is known for its transformative medicines, with nine FDA-approved treatments, focusing on serious diseases.
Regeneron Pharmaceuticals (NASDAQ: REGN) has authorized a new share repurchase program totaling $3 billion to buy back outstanding common stock. This initiative aims to enhance shareholder value and is supported by the company's strong balance sheet. As of November 12, 2021, $1.8 million remains available under a previous $1.5 billion repurchase program initiated in January 2021. The repurchase program has no expiration and can be adjusted at management's discretion based on market conditions.
The European Commission has granted marketing authorization for Regeneron's antibody cocktail, REGEN-COV (casirivimab and imdevimab), for the treatment and prevention of COVID-19 in outpatients aged 12 and older. The decision follows prior approvals in Japan, Australia, and the UK. The cocktail demonstrated a 70% reduction in hospitalization or death risk for infected patients and 82% in preventing symptomatic infections. The marketing authorization is based on two Phase 3 trials involving over 6,000 participants. Regeneron is collaborating with Roche for global distribution.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for REGEN-COV, an antibody cocktail for treating and preventing COVID-19 in non-hospitalized patients aged 12 and older. This recommendation is based on successful Phase 3 trials involving over 6,000 participants. A final decision from the European Commission is expected soon. The FDA has also accepted a priority review of the antibody for non-hospitalized patients, while REGEN-COV remains authorized under an EUA in the U.S., supported by a new agreement to supply additional doses.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive results from a Phase 3 trial of REGEN-COV, demonstrating an 81.6% reduction in COVID-19 risk over eight months following a single 1,200 mg dose. There were no hospitalizations in the REGEN-COV group compared to six in the placebo group. The trial involved 1,683 participants who experienced no additional safety issues, further supporting the long-lasting protection of REGEN-COV. The company plans to share these results with regulatory authorities to enhance COVID-19 protection, especially for immunocompromised individuals.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced new data to be presented at the 2021 American Society of Hematology (ASH) Annual Meeting from December 11-14. Highlighted is the updated Phase 1 data for REGN5458, targeting heavily pre-treated multiple myeloma, with a Phase 2 trial currently enrolling. Additionally, first data on the combination of pozelimab and cemdisiran will be shared, aimed at treating paroxysmal nocturnal hemoglobinuria. An investor webcast will take place on December 13 to discuss the hematology portfolio.
Regeneron Pharmaceuticals reported a strong Q3 2021, with revenues soaring by 51% to $3.45 billion, driven largely by REGEN-COV and robust sales of EYLEA and Dupixent. GAAP diluted EPS reached $14.33, a 94% increase year-over-year. EYLEA's net sales climbed 12% to $1.47 billion, while Dupixent's global sales surged 55% to $1.66 billion. The FDA granted expanded approval for Dupixent in children aged 6-11 with asthma. The company is also moving forward with important clinical trials and regulatory submissions related to its diverse pipeline.
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