Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the FDA has accepted for priority review its Biologics License Application (BLA) for REGEN-COV^® (casirivimab and imdevimab) for treating COVID-19 in non-hospitalized patients and for prophylaxis. The FDA's target action date is April 13, 2022. Two Phase 3 trials involving over 6,000 patients supported the BLA. Additionally, a similar submission has been accepted for review by the European Medicines Agency (EMA). The antibody cocktail is currently authorized under Emergency Use Authorization (EUA) for COVID-19 treatment in high-risk individuals.

Regeneron Pharmaceuticals (NASDAQ: REGN) will release its Q3 2021 financial results on November 4, 2021, before U.S. markets open. A conference call and webcast will take place at 8:30 AM ET the same day. Interested participants can access the call via the 'Investors and Media' page on Regeneron's website. Founded by physician-scientists, Regeneron is a leading biotechnology company focused on developing life-changing medicines across various disease areas. Their innovative VelociSuite technologies enhance drug development processes.

Regeneron Pharmaceuticals announced that its COVID-19 treatment, REGEN-COV, successfully met its primary trial endpoint by significantly reducing viral load in hospitalized patients who did not require high-flow oxygen. Key findings indicate a 36% reduced risk of death overall, increasing to 56% in seronegative patients by day 29. The FDA is currently reviewing the authorization request for REGEN-COV in hospital settings. The trial showed positive results for all clinical endpoints, even with a smaller patient pool due to slow enrollment.

Regeneron Pharmaceuticals announced positive results from a Phase 3 trial for its COVID-19 treatment, REGEN-COV (casirivimab and imdevimab), published in the New England Journal of Medicine. The trial revealed a 70% reduction in hospitalization or death for high-risk non-hospitalized patients. The drug's safety profile aligns with prior data. As authorized by the FDA, REGEN-COV targets high-risk patients and is part of ongoing government agreements for supply. Regeneron is also pursuing further regulatory submissions for expanded use.