Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals has announced a new agreement with the U.S. government to provide an additional 1.25 million doses of the casirivimab and imdevimab antibody cocktail, increasing the total potential supply to over 1.5 million doses. The antibody cocktail aims to treat high-risk patients with mild to moderate COVID-19 and is being supplied under FDA Emergency Use Authorization.

The government will purchase the doses at an estimated value of up to $2.625 billion, with 750,000 doses expected by June 30, 2021.

Regeneron Pharmaceuticals has revealed promising initial data from its Phase 1/2/3 trial of the antibody cocktail, casirivimab and imdevimab, for hospitalized COVID-19 patients. The data indicates a lower risk of death or mechanical ventilation in seronegative patients, achieving a hazard ratio of 0.78. These patients showed significant viral load reductions, with declines reaching -0.54 log10 copies/mL by day 7. While no serious adverse events were significant, the study emphasizes the impact of pre-existing immunity. The trial continues alongside the UK RECOVERY trial, with ongoing evaluations needed for conclusive results.

Regeneron Pharmaceuticals announced the publication of initial clinical data on its antibody cocktail, casirivimab and imdevimab, in the New England Journal of Medicine. This Phase 1/2/3 trial involved 275 patients and demonstrated significant reduction in viral load and need for medical visits in non-hospitalized COVID-19 patients. The treatment is available under Emergency Use Authorization, with follow-on data from 799 patients further validating its effectiveness, particularly in individuals without pre-existing antibodies.

Regeneron Pharmaceuticals (NASDAQ: REGN) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 8:20 a.m. ET. The presentation will be available for live streaming on their website. Regeneron is known for developing life-saving medications and has eight FDA-approved treatments. Their innovative drug development processes include proprietary technologies like VelociSuite and the Regeneron Genetics Center, contributing to their robust pipeline targeting serious health issues.

Regeneron Pharmaceuticals (NASDAQ: REGN) presented promising results for REGN5458, a BCMAxCD3 bispecific antibody, at the 2020 ASH Annual Meeting. The Phase 1 trial showed a 63% overall response rate at the highest dose, with 95% of responders achieving a very good partial response or better. Among responding patients with over 6 months of follow-up, 83% maintained responses for up to 13 months. A Phase 2 trial has begun enrolling patients, indicating potential for further development in treating relapsed or refractory multiple myeloma.

Regeneron Pharmaceuticals (NASDAQ: REGN) will host a webcast on December 7, 2020, at 4:30 PM EST. The management team will discuss data from the ASH 2020 Annual Meeting and provide updates on their oncology and hematology portfolio. Investors can access the call at (888) 660-6127 (U.S.) or (973) 890-8355 (International), using conference ID 7442859. A replay will be available on Regeneron’s website for 30 days. Regeneron continues to innovate in biotechnology, with FDA-approved treatments and a pipeline aimed at various severe diseases.

Regeneron Pharmaceuticals announces the European Commission's approval of Dupixent for children aged 6 to 11 with severe atopic dermatitis, reinforcing its long-term safety profile. The pivotal trial showed that over 70% of children achieved a 75% improvement in disease extent and severity. Dupixent, the only systemic treatment approved in the EU for this age group, offers significant improvement in itch reduction and quality of life. Results demonstrated a clear advantage over traditional topical treatments and underscore the unmet needs in this patient population.

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.