Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals announced positive topline results from a Phase 3 trial of REGEN-COV for non-hospitalized COVID-19 patients, involving 4,567 participants. The treatment significantly reduced hospitalization/death risk by 70% (1,200 mg) and 71% (2,400 mg) compared to placebo. Additionally, REGEN-COV shortened symptom duration by an average of 4 days. The FDA updated EUA fact sheets confirming REGEN-COV's potency against emerging variants. Regeneron plans to seek EUA for the lower 1,200 mg dose. First-quarter sales are projected at $260 million to the U.S. government, with an increased supply expectation.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the winners of the 2021 Regeneron Science Talent Search, awarding over $1.8 million to 40 finalists. Yunseo Choi from New Hampshire secured the top prize of $250,000 for her research on matching algorithms. Other notable winners included Noah Getz and Eshani Jha, who received $175,000 and $150,000 respectively, for projects in drug discovery and water filtration. Regeneron's ongoing commitment to education includes a $100 million pledge to support STEM initiatives.

Regeneron Pharmaceuticals and Sanofi announced positive results for Libtayo in a Phase 3 trial for recurrent or metastatic cervical cancer, showing a 31% reduction in the risk of death compared to chemotherapy. The median overall survival was 12.0 months for Libtayo versus 8.5 months for chemotherapy. The trial was halted early due to a unanimous recommendation from the Independent Data Monitoring Committee. Regulatory submissions are planned for 2021. Libtayo has already demonstrated clinical benefits in four cancer types.

Regeneron Pharmaceuticals and Sanofi announced the FDA's acceptance of the supplemental Biologics License Application for Dupixent as an add-on treatment for children aged 6 to 11 with uncontrolled moderate-to-severe asthma. Dupixent has shown a significant reduction in severe asthma attacks and improvement in lung function in a Phase 3 trial. The FDA decision is expected by October 21, 2021. With around 75,000 children affected in the U.S., this milestone marks a step forward in addressing severe asthma driven by type 2 inflammation.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive results from a Phase 2 trial of REGN1908-1909, a novel antibody cocktail aimed at treating cat allergies in patients with mild asthma. The study demonstrated that a single dose effectively prevented early asthma reactions over three months, with significant improvements noted in lung function and allergen tolerance as early as week one. The trial enrolled 56 participants, and results were shared at the 2021 AAAAI Annual Meeting, highlighting promising new strategies for allergy management.

Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency's CHMP for its COVID-19 antibody cocktail, REGEN-COV, which can treat high-risk patients without supplemental oxygen. The endorsement allows EU member states to use this opinion for national decisions prior to market authorization. Roche, Regeneron's collaboration partner, is responsible for distribution outside the U.S. and has started distribution in the EU. Data indicates a significant reduction in virus levels and fewer medical visits for treated patients. This therapy aims to support global COVID-19 management.

Regeneron Pharmaceuticals announced changes to its Phase 3 trial for REGEN-COV™ (casirivimab with imdevimab) in non-hospitalized COVID-19 patients. Following the Independent Data Monitoring Committee's recommendation, enrollment in the placebo group will be halted due to demonstrated clinical efficacy in reducing hospitalization and death rates with the 1,200 mg and 2,400 mg doses. Continued enrollment will focus on these treatment groups, with detailed results expected in March 2021. REGEN-COV is currently available in the U.S. under Emergency Use Authorization.

Regeneron and Sanofi announced FDA approval for Libtayo® (cemiplimab-rwlc) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression. This approval, based on a pivotal trial with 710 patients, demonstrated that Libtayo improved overall survival (OS) by 32% over chemotherapy, with a median OS of 22 months versus 14 months. The trial also showed a notable crossover rate of over 70% to Libtayo post-chemotherapy. This is the third FDA approval for Libtayo, which is also effective in basal cell carcinoma and squamous cell carcinoma.