Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Ultragenyx Pharmaceutical have announced a collaboration to develop, commercialize, and distribute Evkeeza® (evinacumab) outside the U.S. Regeneron will receive a $30 million upfront payment and is eligible for up to $63 million in additional milestone payments. Evkeeza, approved in the EU in June 2021, is a first-in-class treatment for homozygous familial hypercholesterolemia (HoFH). This partnership aims to enhance patient access to this vital therapy for debilitating genetic conditions globally.

Regeneron Pharmaceuticals (NASDAQ: REGN) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 10:30 a.m. ET. The presentation will be available via webcast on Regeneron's website, with an archived version accessible for 30 days. Regeneron focuses on developing life-transforming medicines, having nine FDA-approved treatments and several candidates in the pipeline. Its proprietary technologies, including VelociSuite, enhance drug development processes, while the Regeneron Genetics Center leads extensive genetic sequencing initiatives.

Regeneron Pharmaceuticals and Sanofi reported positive Phase 3 trial results for Dupixent in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The trial met all primary and secondary endpoints, showing significant improvements in skin clearance and disease severity. Key results include 28% achieving clear skin versus 4% with placebo, and a 70% average improvement in disease severity. Global regulatory filings are planned, starting with the U.S. by the end of 2021. The safety profile aligns with previous studies in older patients, enhancing expectations for market acceptance.

On December 11, 2021, Regeneron Pharmaceuticals (NASDAQ: REGN) presented new data for REGN5458, a bispecific antibody targeting multiple myeloma, at the ASH Annual Meeting. Results from the Phase 1 portion of the trial showed a 51% overall response rate (ORR) across all dose groups, with a significant boost to 75% at higher doses (200-800 mg). The study reported a 90% probability of being event-free 8 months after response. With 73 patients treated, the safety profile was consistent, showing manageable adverse events.

Regeneron (NASDAQ: REGN) and Sanofi announced positive Phase 3 results for Dupixent (dupilumab) in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial demonstrated significant reductions in severe asthma attacks and improved lung function. These findings support Dupixent's recent FDA approval for this patient group. The publication of results in the New England Journal of Medicine reinforces Dupixent's established safety profile, with 83% adverse event rates reported. Regulatory reviews for Dupixent in the EU are ongoing, with a decision expected in Q1 2022.

Regeneron Pharmaceuticals (NASDAQ: REGN) will participate in a virtual fireside chat at the H.C. Wainwright & Co. event on December 6, 2021, at 2:00 p.m. ET. Aris Baras, M.D., Senior Vice President and Head of the Regeneron Genetics Center, will represent the company. The session can be accessed via Regeneron's 'Investors & Media' page and will be archived for replay for at least 30 days. Regeneron is known for its transformative medicines, with nine FDA-approved treatments, focusing on serious diseases.