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. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
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.
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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.