Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

On September 29, 2020, Regeneron Pharmaceuticals announced promising results from a Phase 1/2/3 trial of REGN-COV2, its investigational antibody cocktail for COVID-19. The study showed significant reductions in viral load and symptom duration among non-hospitalized patients, particularly those without effective immune responses. Results indicated faster symptom alleviation and a favorable safety profile; both high and low doses of REGN-COV2 were well-tolerated. Regeneron plans to discuss these findings with regulatory agencies and host a webcast for investors.

Regeneron Pharmaceuticals and Sanofi presented positive data from a pivotal trial of Libtayo (cemiplimab) for first-line treatment of advanced non-small cell lung cancer (NSCLC) at the ESMO Virtual Congress 2020. Libtayo demonstrated a 32% reduction in risk of death compared to chemotherapy, with a median overall survival of 22 months versus 14 months for chemotherapy. In patients with PD-L1 expression ≥50%, Libtayo showed a 43% reduction in death risk. The drug is being developed under a global collaboration agreement.

Regeneron Pharmaceuticals and Sanofi announced promising results from the Phase 2 trial of Libtayo® (cemiplimab) for advanced basal cell carcinoma (BCC) after hedgehog inhibitor therapy. The trial, presented at the ESMO Virtual Congress 2020, reported a 31% objective response rate (ORR) with 85% of responses ongoing at one year. Key findings include a median follow-up of 15 months, with a probability of overall survival at 92%. No new safety signals were observed, though 17% of patients discontinued treatment due to adverse events. Libtayo is still under investigation for this indication.