Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi announced that the FDA granted Breakthrough Therapy designation to Dupixent for treating eosinophilic esophagitis (EoE) in patients 12 and older. This designation follows positive results from a Phase 3 trial, where Dupixent met its primary and secondary endpoints, showcasing significant symptom reduction and improved esophageal health. With approximately 160,000 patients in the U.S. affected by EoE and no FDA-approved treatments, this designation highlights Dupixent's potential as a first-in-class therapy for this chronic condition.

Regeneron Pharmaceuticals and Sanofi announced results from a Phase 3 open-label extension trial for Dupixent, the largest study of a biologic in asthma with over 2,200 patients. Results indicate sustained improvements in lung function and reduced severe asthma attacks over three years. The average change in FEV1 was 13-22%, with low rates of severe attacks averaging 0.31-0.35 events per year. Safety profiles showed AE rates consistent with previous trials. The data emphasizes Dupixent's role as a long-term treatment option for patients suffering from moderate-to-severe asthma.

Sanofi and Regeneron Pharmaceuticals (NASDAQ: REGN) will present promising data for Libtayo® (cemiplimab) at the ESMO Virtual Congress 2020 from September 19-21. Key highlights include late-breaking oral presentations on Libtayo monotherapy for first-line advanced non-small cell lung cancer (NSCLC) and advanced basal cell carcinoma (BCC) post-hedgehog inhibitor treatment. The clinical trials demonstrate Libtayo's effectiveness across various cancers, which may support regulatory submissions in the U.S. and EU. Additional presentations will focus on patient quality of life and treatment demographics.

Regeneron Pharmaceuticals and Sanofi presented promising new data for Libtayo® (cemiplimab) at the ESMO Virtual Congress 2020. Key highlights include late-breaking oral presentations on Libtayo's efficacy as a monotherapy for first-line advanced non-small cell lung cancer (NSCLC) and locally advanced basal cell carcinoma (BCC) in patients resistant to hedgehog inhibitors. The trials show Libtayo's potential to improve treatment outcomes in challenging cancers, supporting regulatory submissions in the U.S. and EU.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the New England Journal of Medicine published positive Phase 3 trial results for evinacumab in patients with homozygous familial hypercholesterolemia (HoFH). This investigational drug significantly reduced LDL cholesterol levels by 49% when added to standard therapies, especially in patients with low or no LDL-receptor activity. Evinacumab is under FDA Priority Review, with a decision expected by February 11, 2021, addressing a critical need for effective treatment in HoFH patients.

On August 19, 2020, Regeneron and Roche announced a collaboration to develop, manufacture, and distribute REGN-COV2, Regeneron's antibody cocktail for COVID-19. This partnership aims to increase production capacity by over 350%, significantly boosting the availability of doses for patients both in the U.S. and globally. REGN-COV2 is currently undergoing Phase 2/3 trials for treatment and Phase 3 trials for prevention. The companies are committed to sharing distribution responsibilities, with Regeneron handling U.S. sales and Roche focusing on international markets.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance for Priority Review of its Biologics License Application (BLA) for evinacumab, targeting patients with homozygous familial hypercholesterolemia (HoFH). HoFH affects approximately 1,300 patients in the U.S., many of whom do not achieve optimal LDL-C levels with existing therapies. Evinacumab is designed to block angiopoietin-like 3 (ANGPTL3) to lower LDL-C. The FDA's target action date is February 11, 2021, and the drug has previously received Breakthrough Therapy designation.

Regeneron Pharmaceuticals announced the pricing of its underwritten offering of $1.250 billion in senior unsecured notes due 2030 with a 1.750% interest rate, and $750 million in notes due 2050 with a 2.800% interest rate. The issuance is expected to close around August 12, 2020. The funds will be used primarily to repay outstanding loans related to a stock repurchase from Sanofi and for general corporate purposes. The offering will support Regeneron's financial stability as it continues its drug development efforts.