Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) targeting children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. This approval could make Dupixent the first biologic treatment for this age group, with a decision expected by June 9, 2022. The application is backed by successful Phase 3 trial results showing improved skin clearance and reduced disease severity compared to standard treatments, while safety results align with earlier data for older patients.

Regeneron Pharmaceuticals reported strong financial results for Q4 and FY 2021, with revenues soaring by 104% to $4.95 billion and 89% to $16.07 billion, respectively. Key drivers included $2.30 billion from REGEN-COV and significant growth in EYLEA and Dupixent sales. GAAP diluted EPS rose to $19.69 for Q4 and $71.97 for FY 2021. Despite success, the FDA's revision of REGEN-COV's Emergency Use Authorization raised concerns as it is not effective against the Omicron variant. The company aims to expand Dupixent's indications and develop next-generation antibodies.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced promising Dupixent (dupilumab) data set to be presented at the AAAAI Annual Meeting from February 25 to 28, 2022. Highlights include significant disease improvements in eosinophilic esophagitis and chronic spontaneous urticaria, with 18 abstracts supporting Dupixent’s role in type 2 inflammation. The ongoing clinical investigations have not yet received regulatory approval. Dupixent is already approved for various indications, with over 350,000 patients treated globally.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Dupixent (dupilumab) to treat children aged 6 to 11 years with severe asthma characterized by type 2 inflammation. This recommendation is based on a Phase 3 trial demonstrating significant reductions in severe asthma attacks and improved lung function. The European Commission is expected to make a final decision soon. Dupixent is already FDA-approved for similar indications in the U.S. and has shown a well-established safety profile.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi have voluntarily withdrawn the supplemental Biologics License Application for Libtayo (cemiplimab) as a second-line treatment for advanced cervical cancer after failing to align with the FDA on post-marketing studies. Approximately 570,000 cervical cancer cases are diagnosed globally each year. Current indications for Libtayo include advanced basal cell carcinoma, cutaneous squamous cell carcinoma, and non-small cell lung cancer, but it is not approved for advanced cervical cancer.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the 40 finalists for the 2022 Regeneron Science Talent Search, highlighting the top high school scholars in STEM. Selected from 1,804 entrants, these finalists demonstrate significant research potential across diverse fields, including COVID-19 impact studies and novel therapeutic tools. The finalists compete for over $1.8 million in awards, with each receiving at least $25,000. The winners will be announced during a live-streamed ceremony on March 15, 2022. This initiative reflects Regeneron's commitment to supporting future science leaders.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the FDA has accepted its supplemental Biologics License Application for Libtayo® (cemiplimab-rwlc) in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC). This application is supported by a Phase 3 trial, demonstrating significant overall survival improvement over chemotherapy alone, leading to early termination of the trial. Libtayo is already approved for patients with high PD-L1 expression. A regulatory filing has also been submitted to the European Medicines Agency.

Regeneron Pharmaceuticals and Sanofi have announced positive results from a second Phase 3 trial of Dupixent (dupilumab) for uncontrolled prurigo nodularis. The PRIME trial demonstrated that 60% of patients on Dupixent achieved significant itch reduction, compared to only 18% for the placebo group, at 24 weeks. Additionally, 48% of Dupixent patients experienced near-clear skin compared to 18% in the placebo group. The safety profile remained consistent with previous studies, with lower skin infection rates noted. These findings further support Dupixent's efficacy in addressing type 2 inflammatory diseases.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced its fourth quarter and full year 2021 financial results will be reported on February 4, 2022, before U.S. market opening. A conference call and webcast will occur at 8:30 AM ET on the same day. Participants can join via webcast on the company’s website.

As a leading biotechnology firm, Regeneron focuses on innovative medicines addressing serious diseases, leveraging proprietary technologies and significant research initiatives.