Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals and Sanofi reported positive Phase 3 trial results for Dupixent in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The trial met all primary and secondary endpoints, showing significant improvements in skin clearance and disease severity. Key results include 28% achieving clear skin versus 4% with placebo, and a 70% average improvement in disease severity. Global regulatory filings are planned, starting with the U.S. by the end of 2021. The safety profile aligns with previous studies in older patients, enhancing expectations for market acceptance.

On December 11, 2021, Regeneron Pharmaceuticals (NASDAQ: REGN) presented new data for REGN5458, a bispecific antibody targeting multiple myeloma, at the ASH Annual Meeting. Results from the Phase 1 portion of the trial showed a 51% overall response rate (ORR) across all dose groups, with a significant boost to 75% at higher doses (200-800 mg). The study reported a 90% probability of being event-free 8 months after response. With 73 patients treated, the safety profile was consistent, showing manageable adverse events.

Regeneron (NASDAQ: REGN) and Sanofi announced positive Phase 3 results for Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial demonstrated significant reductions in severe asthma attacks and improved lung function. These findings support Dupixent's recent FDA approval for this patient group. The publication of results in the New England Journal of Medicine reinforces Dupixent's established safety profile, with 83% adverse event rates reported. Regulatory reviews for Dupixent in the EU are ongoing, with a decision expected in Q1 2022.

Regeneron Pharmaceuticals (NASDAQ: REGN) will participate in a virtual fireside chat at the H.C. Wainwright & Co. event on December 6, 2021, at 2:00 p.m. ET. Aris Baras, M.D., Senior Vice President and Head of the Regeneron Genetics Center, will represent the company. The session can be accessed via Regeneron's 'Investors & Media' page and will be archived for replay for at least 30 days. Regeneron is known for its transformative medicines, with nine FDA-approved treatments, focusing on serious diseases.

Regeneron Pharmaceuticals (NASDAQ: REGN) has authorized a new share repurchase program totaling $3 billion to buy back outstanding common stock. This initiative aims to enhance shareholder value and is supported by the company's strong balance sheet. As of November 12, 2021, $1.8 million remains available under a previous $1.5 billion repurchase program initiated in January 2021. The repurchase program has no expiration and can be adjusted at management's discretion based on market conditions.

The European Commission has granted marketing authorization for Regeneron's antibody cocktail, REGEN-COV (casirivimab and imdevimab), for the treatment and prevention of COVID-19 in outpatients aged 12 and older. The decision follows prior approvals in Japan, Australia, and the UK. The cocktail demonstrated a 70% reduction in hospitalization or death risk for infected patients and 82% in preventing symptomatic infections. The marketing authorization is based on two Phase 3 trials involving over 6,000 participants. Regeneron is collaborating with Roche for global distribution.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for REGEN-COV, an antibody cocktail for treating and preventing COVID-19 in non-hospitalized patients aged 12 and older. This recommendation is based on successful Phase 3 trials involving over 6,000 participants. A final decision from the European Commission is expected soon. The FDA has also accepted a priority review of the antibody for non-hospitalized patients, while REGEN-COV remains authorized under an EUA in the U.S., supported by a new agreement to supply additional doses.