Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 results for Libtayo in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC). The trial met its overall survival and key secondary endpoints, with a median overall survival of 22 months vs. 13 months for chemotherapy alone. The study included 466 patients with diverse characteristics. Libtayo significantly improved patient-reported outcomes and quality of life measures. The results will support regulatory submissions, with an investor webcast scheduled for September 20, 2021.

Regeneron Pharmaceuticals (NASDAQ: REGN) has secured a new agreement to supply an additional 1.4 million doses of its COVID-19 treatment REGEN-COV to the U.S. government. This brings the total purchased doses to nearly 3 million. Authorized for use in high-risk patients, REGEN-COV has shown to reduce hospitalization or death risk by 70% when administered early. The current agreement, priced at $2,100 per dose, will see deliveries start in September 2021, primarily in Q4 2021. Regeneron will record all net sales associated with this agreement.

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.