Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive results from a Phase 3 trial of REGEN-COV, demonstrating an 81.6% reduction in COVID-19 risk over eight months following a single 1,200 mg dose. There were no hospitalizations in the REGEN-COV group compared to six in the placebo group. The trial involved 1,683 participants who experienced no additional safety issues, further supporting the long-lasting protection of REGEN-COV. The company plans to share these results with regulatory authorities to enhance COVID-19 protection, especially for immunocompromised individuals.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced new data to be presented at the 2021 American Society of Hematology (ASH) Annual Meeting from December 11-14. Highlighted is the updated Phase 1 data for REGN5458, targeting heavily pre-treated multiple myeloma, with a Phase 2 trial currently enrolling. Additionally, first data on the combination of pozelimab and cemdisiran will be shared, aimed at treating paroxysmal nocturnal hemoglobinuria. An investor webcast will take place on December 13 to discuss the hematology portfolio.

Regeneron Pharmaceuticals reported a strong Q3 2021, with revenues soaring by 51% to $3.45 billion, driven largely by REGEN-COV and robust sales of EYLEA and Dupixent. GAAP diluted EPS reached $14.33, a 94% increase year-over-year. EYLEA's net sales climbed 12% to $1.47 billion, while Dupixent's global sales surged 55% to $1.66 billion. The FDA granted expanded approval for Dupixent in children aged 6-11 with asthma. The company is also moving forward with important clinical trials and regulatory submissions related to its diverse pipeline.

Regeneron and Sanofi announced positive results from a second Phase 3 trial of Dupixent (dupilumab) for eosinophilic esophagitis (EoE). The trial demonstrated significant improvements in swallowing ability and reduced eosinophils in the esophagus for patients treated with Dupixent 300 mg weekly compared to placebo. With a 64% reduction in symptoms and better histological outcomes, this positions Dupixent as the first biologic to show such results in EoE. Regulatory submissions are planned for 2022, potentially expanding treatment options for approximately 160,000 U.S. patients affected by EoE.

Regeneron Pharmaceuticals and Sanofi announced positive results from a pivotal Phase 3 trial of Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, achieving primary and key secondary endpoints. The trial demonstrated significant reductions in itch and skin lesions, with 37% of Dupixent patients showing improvement at week 12 and nearly three times more at week 24 compared to placebo. Prurigo nodularis affects around 74,000 people in the U.S., many of whom have limited treatment options. Regulatory submissions for Dupixent in this indication are anticipated in 2022.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe asthma, making it the only biologic approved for this age group. The approval is based on a Phase 3 trial, showing a 65% reduction in severe asthma attacks and improved lung function within two weeks. Approximately 75,000 children in the U.S. suffer from uncontrolled asthma, highlighting the importance of this treatment. Dupixent is also being reviewed for similar indications in the EU.