Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced that the EMA's CHMP has issued positive opinions for Libtayo (cemiplimab) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) and for advanced basal cell carcinoma (BCC). Libtayo is recommended for NSCLC patients with ≥50% PD-L1 expression and without specific genetic aberrations. The recommendation for BCC comes after patients have progressed on or are intolerant to hedgehog pathway inhibitors. The European Commission will decide on these applications soon.

Regeneron Pharmaceuticals (REGN) announced Michelle Hua, 16, as the top prize winner at the 2021 Regeneron International Science and Engineering Fair, receiving a $75,000 award for her innovative AI algorithm in human action recognition. This year marked the event's first virtual format, showcasing over 1,800 young scientists from 49 states and 64 countries. Over $5 million in total prizes were awarded. The initiative aims to inspire young STEM leaders, highlighting the importance of scientific inquiry, especially during the COVID-19 pandemic.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive clinical data for the combination of fianlimab (LAG-3 inhibitor) and Libtayo (cemiplimab) in advanced melanoma, achieving a 64% objective response rate in PD-1 inhibitor naïve patients. Upcoming presentations at the ASCO Annual Meeting from June 4-8 will cover various cancers, including lung and skin cancers, focusing on Libtayo's impact on quality of life. An investor webcast is scheduled for June 7 to discuss further updates on its oncology portfolio.

Regeneron Pharmaceuticals reported promising results from its Phase 3 trial of REGEN-COV, demonstrating significant efficacy in treating high-risk COVID-19 outpatients. Patients receiving REGEN-COV experienced a 70-71% reduced risk of hospitalization or death and a 4-day shorter symptom duration compared to placebo. The U.S. FDA is reviewing a request to authorize a lower 1,200 mg dose. The trial involved 4,567 participants, highlighting the treatment's potential for individuals with conditions like asthma and obesity. Safety assessments showed a low rate of serious adverse events.

Regeneron Pharmaceuticals and Sanofi announced positive Phase 3 trial results for Dupixent (dupilumab), demonstrating significant efficacy in improving lung function and reducing severe asthma attacks in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. The trial revealed a 65% reduction in asthma attacks and rapid improvements in lung function within two weeks. FDA approval for this indication is expected by October 21, 2021. The study highlights Dupixent's potential as a best-in-class treatment, targeting type 2 inflammation, a common cause of asthma in this population.

Regeneron and Sanofi announced positive Phase 3 trial results for Libtayo (cemiplimab) in advanced cervical cancer, demonstrating a 31% reduction in the risk of death compared to chemotherapy. Significant improvements were observed in overall survival, progression-free survival, and objective response rate. The study included 304 patients in each treatment group, revealing a median response duration of 16 months for Libtayo versus 7 months for chemotherapy. The findings support Libtayo as a potential second-line treatment, with regulatory submissions expected in 2021.

Regeneron Pharmaceuticals reported a strong first quarter of 2021 with revenues of $2.53 billion, up 38% from 2020. Net sales of EYLEA rose 15% to $1.35 billion, and Dupixent global net sales increased 48% to $1.26 billion. GAAP diluted EPS reached $10.09, a significant increase compared to $5.43 in Q1 2020. The company received three FDA approvals and reported positive Phase 3 results for REGEN-COV in COVID-19 treatment and prevention. Strong growth is anticipated in EYLEA and Dupixent, with a solid pipeline of approximately 30 product candidates in clinical development.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 3 results for two of its medicines at the upcoming 2021 ATS International Conference, scheduled for May 17. The studies include REGEN-COV™, an investigational COVID-19 treatment for high-risk outpatients, and Dupixent®, for children aged 6 and older with uncontrolled asthma. These findings underscore Regeneron's commitment to advancing healthcare solutions. Presentations also cover Dupixent's impact on corticosteroid use in adults and data on chronic rhinosinusitis treatment.