Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

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.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that its supplemental Biologics License Application for the PD-1 inhibitor Libtayo^® has been accepted for priority review by the FDA to treat recurrent or metastatic cervical cancer. The FDA's decision is expected by January 30, 2022. The application is supported by data from a Phase 3 trial involving patients with cervical cancer who had progressed on chemotherapy. Global regulatory submissions, including the European Union, are anticipated by the end of 2021.

On September 21, 2021, Regeneron announced over 30 presentations about Dupixent (dupilumab), focusing on its effectiveness against moderate-to-severe atopic dermatitis in patients as young as six. These results, showcasing the longest data duration for any biologic in adults with the condition, will be discussed at the upcoming WCPD and EADV congresses. Significant findings include improved measures of itch, disease severity, and quality of life for children and adults, as well as insights from extensive real-world evidence.

Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 results for Libtayo in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC). The trial met its overall survival and key secondary endpoints, with a median overall survival of 22 months vs. 13 months for chemotherapy alone. The study included 466 patients with diverse characteristics. Libtayo significantly improved patient-reported outcomes and quality of life measures. The results will support regulatory submissions, with an investor webcast scheduled for September 20, 2021.