Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 2 trial results for high-dose aflibercept in treating wet age-related macular degeneration (AMD). The trial met its primary safety endpoint, showing no new safety signals. In a cohort of 106 patients, 43.4% in the aflibercept 8 mg group exhibited no retinal fluid compared to 26.4% in the 2 mg EYLEA group. Phase 3 trials for wet AMD and diabetic macular edema are fully recruited, with results anticipated in late 2022, assessing safety and efficacy for up to two years.

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.