Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

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.

Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab), extending its approval in the EU for children aged 6 to 11 years with severe atopic dermatitis suitable for systemic therapy. Dupixent, a biologic, is already approved for older patients in the EU and U.S. Efficacy data from Phase 3 trials showed significant improvement in disease measures when combined with topical corticosteroids. A final decision by the European Commission is forthcoming.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced FDA approval for Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) as the first treatment for Zaire ebolavirus infection in patients of all ages. Inmazeb demonstrated superiority in reducing mortality compared to ZMapp and remdesivir in a clinical trial involving 681 patients. The approval was facilitated by a collaboration with BARDA, ensuring a steady supply for public health emergencies. Regeneron remains committed to making Inmazeb accessible and continues support for Ebola response efforts in affected regions.

Regeneron Pharmaceuticals and Sanofi announced that Dupixent (dupilumab) successfully met its primary and key secondary endpoints in a Phase 3 trial for children aged 6-11 with uncontrolled moderate-to-severe asthma. The study showed Dupixent reduced severe asthma attacks by up to 65% and improved lung function significantly within two weeks. Regulatory submissions in the U.S. and EU for this age group are anticipated by Q1 2021. The safety profile was consistent with previous findings, showing Dupixent as a promising option for children suffering from this serious condition.

Regeneron Pharmaceuticals (NASDAQ: REGN) will report its third quarter 2020 financial results on November 5, 2020, before the U.S. markets open. A conference call and webcast will be held at 8:30 AM ET on the same day. To participate, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International) with conference ID 1535889. Regeneron is known for developing life-transforming medicines and has seven FDA-approved treatments. Its innovative technologies, like VelociSuite, enhance drug development processes.