Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (NASDAQ: REGN) will participate in a virtual fireside chat at the Guggenheim Biopharma Strategy Series on June 29, 2021, at 10:00 a.m. ET. The event will focus on global strategy and innovation in biopharma.

A live audio webcast can be accessed via Regeneron's 'Investors and Media' webpage, with an archived replay available for 30 days post-event. Regeneron is renowned for its innovative medicines addressing serious diseases, with a robust pipeline supported by advanced technologies like VelociSuite®.

Regeneron's investigational treatment, REGEN-COV, demonstrated a 20% reduction in mortality among hospitalized COVID-19 patients without an immune response, according to the UK RECOVERY trial. This landmark study marks the first evidence that any monoclonal antibody therapy can improve survival rates in severe cases. REGEN-COV significantly shortened hospital stays by an average of 4 days and increased the likelihood of discharge alive at day 28. Regeneron plans to expand its Emergency Use Authorization (EUA) to include these patients, aiming for broader access to this effective therapy.

Regeneron Pharmaceuticals announced the FDA's updated Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg, which reduces the risk of hospitalization or death by 70%. REGEN-COV remains the only antibody therapy available in all 50 states and is provided free of charge by the U.S. government. The updated EUA is based on pivotal Phase 3 data showing its effectiveness against COVID-19 variants. Regeneron expects to submit a full Biologics License Application later this summer and plans to deliver at least 1 million doses to the government in Q2 2021.

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.