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 Pharmaceuticals has received Conditional Marketing Authorization from the UK MHRA for its antibody cocktail, REGEN-COV™, to prevent and treat acute COVID-19 infection. This approval enables distribution across the UK, including Northern Ireland, targeting high-risk patients, particularly those unsuitable for vaccines. Over the past week, Regeneron distributed over 130,000 doses in the U.S. The company submitted the first Biologics License Application to the FDA for REGEN-COV, with the second submission focusing on hospitalized patients expected later this year.
Regeneron Pharmaceuticals reported a remarkable 163% increase in total revenues, reaching $5.14 billion in Q2 2021. This surge includes $2.76 billion from REGEN-COV. Excluding REGEN-COV, revenues grew 22%. Notable product performances include EYLEA, with a 28% increase to $1.42 billion, and Dupixent, which rose 59% to $1.50 billion. GAAP diluted EPS also soared to $27.97. The FDA updated the Emergency Use Authorization for REGEN-COV, and Libtayo's Phase 3 trial in lung cancer showed significant survival benefits.
On August 5, 2021, Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced the early termination of a Phase 3 trial for Libtayo, a PD-1 inhibitor, after it achieved its primary endpoint of improved overall survival (OS) in advanced non-small cell lung cancer (NSCLC) patients. The combination of Libtayo and chemotherapy increased median OS from 13 to 22 months, representing a 29% reduction in the risk of death. Data from the trial will support regulatory submissions in the U.S. and EU. The trial involved 466 patients with various PD-L1 expression levels, demonstrating substantial efficacy.
Regeneron Pharmaceuticals announced positive results from a Phase 3 trial for REGEN-COV (casirivimab and imdevimab) published in the New England Journal of Medicine. The trial demonstrated an 81% reduction in symptomatic COVID-19 infections among household contacts of infected individuals (p<0.001), with a 93% reduction observed after the first week. The study's results affirm the treatment's effectiveness against prevalent variants, addressing the unmet needs of immunocompromised patients. REGEN-COV's usage has surged, surpassing 50,000 weekly doses in the U.S., as the company continues collaborations to enhance global supply.
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the winners of the 2021 Regeneron Prize for Creative Innovation, recognizing postdoctoral fellows and graduate students in biomedical research. Sergey D. Stavisky from Stanford University and Nitsan Goldstein from the University of Pennsylvania won in their respective categories, each receiving $50,000, with a $5,000 donation to their institutions. This initiative aims to foster creativity in scientific research, particularly in areas like neurology, which have gained importance during the COVID-19 pandemic.
Regeneron Pharmaceuticals announced that the FDA expanded the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab), allowing it for post-exposure prophylaxis in high-risk individuals exposed to COVID-19. Phase 3 data showed an 81% reduction in symptomatic infections among close contacts. REGEN-COV is the only authorized COVID-19 antibody therapy for both treatment and prevention, retaining efficacy against key variants. The use of REGEN-COV is growing rapidly in the U.S. to combat ongoing outbreaks.
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi have announced that Dupixent (dupilumab) has met primary and key secondary endpoints in a pivotal Phase 3 trial for chronic spontaneous urticaria (CSU). The study demonstrated a nearly twofold reduction in itch and urticaria activity at 24 weeks for patients receiving Dupixent alongside antihistamines. Approximately 300,000 people in the U.S. suffer from moderate-to-severe CSU. The trial showcased Dupixent’s well-established safety profile, with similar adverse events reported between Dupixent and placebo groups.
Regeneron Pharmaceuticals (NASDAQ: REGN) and AstraZeneca have formed a collaboration to research and commercialize small molecule compounds targeting the GPR75 gene, linked to obesity and related health issues. This partnership follows a significant discovery by Regeneron's Genetics Center, identifying genetic mutations associated with lower obesity risk. The companies will share research costs and potential profits equally. This initiative responds to the global obesity epidemic, which has drastically increased in prevalence, affecting approximately 650 million adults worldwide.
Regeneron Pharmaceuticals (REGN) announced that Japan's Ministry of Health, Labour and Welfare approved its COVID-19 antibody cocktail, casirivimab and imdevimab, known as Ronapreve™ in Japan. This is the first full approval for the treatment, following temporary authorizations in over 20 countries, including the U.S. The approval is based on a Phase 3 trial demonstrating a 70% reduction in hospitalization or death among high-risk, non-hospitalized patients. The company is collaborating with Roche to enhance global supply, with Chugai handling commercialization in Japan.
Regeneron Pharmaceuticals (NASDAQ: REGN) will disclose its second quarter 2021 financial and operating results on August 5, 2021, prior to the opening of U.S. markets. A conference call and webcast will occur at 8:30 AM ET on the same day. Interested parties can join the call by dialing (888) 660-6127 for U.S. callers or (973) 890-8355 for international attendees, using conference ID 9098036. The webcast link will be available on Regeneron's website, with a recorded replay accessible for at least 30 days.
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