Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

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.

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.