Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals has received Emergency Use Authorization (EUA) from the FDA for its monoclonal antibody cocktail, REGEN-COV2, for recently diagnosed, mild to moderate COVID-19 in high-risk patients. The therapy, consisting of casirivimab and imdevimab, is set to be made available at no out-of-pocket cost to approximately 300,000 patients under a U.S. government allocation program. Initial doses will be supplied to around 80,000 patients by the end of November, increasing to 300,000 by January 2021. Clinical trials showed significant reductions in viral levels, particularly in high-risk patients.

Regeneron Pharmaceuticals reported a strong Q3 2020, with revenues rising 32% to $2.29 billion, driven by EYLEA and Dupixent sales. EYLEA net sales increased 11% to $1.32 billion, while Dupixent saw a 69% jump in global net sales to $1.07 billion. GAAP diluted EPS was $7.39, while non-GAAP diluted EPS reached $8.36. The REGN-COV2 trial showed promising results for COVID-19, earning FDA priority review for treatments Libtayo and Inmazeb. Regeneron also announced significant pipeline progress, with over 20 product candidates in development.

Regeneron Pharmaceuticals (NASDAQ: REGN) has received a recommendation from the Independent Data Monitoring Committee (IDMC) to pause enrollment in the REGN-COV2 trial for hospitalized patients requiring high-flow oxygen or mechanical ventilation due to safety concerns. However, enrollment for patients requiring low-flow oxygen or no oxygen will continue, as the risk-benefit profile remains acceptable. The IDMC also suggests that the outpatient trial proceed without modification. Regeneron is working with the FDA and is committed to implementing these recommendations.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted the supplemental Biologics License Application for its PD-1 inhibitor, Libtayo (cemiplimab-rwlc), for treating first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The FDA's target decision date is February 28, 2021. This application is based on a Phase 3 trial comparing Libtayo to chemotherapy. The EMA is also reviewing Libtayo, with a decision expected in Q2 2021.

TARRYTOWN, N.Y., Oct. 28, 2020 /PRNewswire/ -- Regeneron reported positive results from a Phase 2/3 trial of its investigational COVID-19 antibody cocktail, REGN-COV2. Data from an additional 524 patients confirmed significant reductions in both viral load and medical visits. The treatment reduced COVID-19 related medical visits by 57% overall and 72% in high-risk patients. Regeneron has submitted these results to the U.S. FDA for Emergency Use Authorization. The trial demonstrated no significant differences in outcomes between high and low doses of REGN-COV2, leading to potential dosing changes in ongoing trials.

Regeneron Pharmaceuticals and Sanofi announced positive results from a pivotal Phase 3 trial of Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in patients aged 12 and older. The trial demonstrated significant improvements in patients' ability to swallow, structural abnormalities in the esophagus, and reduced eosinophil counts. Presented at virtual ACG 2020 and UEG Week 2020, the data showed that 64% of patients treated with Dupixent achieved eosinophil levels below the diagnostic threshold. The FDA granted Breakthrough Therapy designation for Dupixent in EoE in September 2020.