Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals (REGN) announced that Japan's Ministry of Health, Labour and Welfare approved its COVID-19 antibody cocktail, casirivimab and imdevimab, known as Ronapreve™ in Japan. This is the first full approval for the treatment, following temporary authorizations in over 20 countries, including the U.S. The approval is based on a Phase 3 trial demonstrating a 70% reduction in hospitalization or death among high-risk, non-hospitalized patients. The company is collaborating with Roche to enhance global supply, with Chugai handling commercialization in Japan.

Regeneron Pharmaceuticals (NASDAQ: REGN) will disclose its second quarter 2021 financial and operating results on August 5, 2021, prior to the opening of U.S. markets. A conference call and webcast will occur at 8:30 AM ET on the same day. Interested parties can join the call by dialing (888) 660-6127 for U.S. callers or (973) 890-8355 for international attendees, using conference ID 9098036. The webcast link will be available on Regeneron's website, with a recorded replay accessible for at least 30 days.

Regeneron Pharmaceuticals, Inc. has announced a significant discovery by its Regeneron Genetics Center regarding the GPR75 gene, which offers protection against obesity. A study published in Science indicates individuals with mutations in this gene have a 54% lower risk of obesity, weighing on average 12 pounds less. The research analyzed genetic data from 645,000 participants and suggests a potential therapeutic pathway using Regeneron's VelocImmune and siRNA technologies in collaboration with Alnylam Pharmaceuticals. This breakthrough may lead to new treatments for obesity, affecting over 1 billion people globally by 2030.

Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency has approved an update to the Dupixent® (dupilumab) summary of product characteristics. This update includes long-term safety results for adults with moderate-to-severe atopic dermatitis based on a positive opinion by the CHMP. The data from a Phase 3 open-label extension trial indicated that Dupixent's long-term safety profile remains consistent with previous studies. Dupixent is currently the only biologic approved in the EU for severe atopic dermatitis in children as young as six.

Intellia Therapeutics and Regeneron Pharmaceuticals announced promising interim results from a Phase 1 trial of NTLA-2001 for treating hereditary transthyretin amyloidosis (ATTRv-PN). The single 0.3 mg/kg dose led to an impressive 87% mean reduction in serum TTR levels, with a maximum reduction of 96% observed by day 28. The treatment showed a favorable safety profile, with no serious adverse events reported among the first six patients. Data was published in The New England Journal of Medicine and presented at the Peripheral Nerve Society Annual Meeting. Future expansions of the trial are planned.

The European Commission has approved Regeneron Pharmaceuticals' Libtayo® (cemiplimab) for treating adults with advanced basal cell carcinoma (BCC) who have progressed on or are intolerant to hedgehog pathway inhibitors. This decision is based on the largest trial to date, indicating an objective response rate of 32% for locally advanced BCC and 29% for metastatic BCC. Notably, approximately 90% of patients experienced a duration of response of 6 months or longer. Libtayo is now approved for three advanced cancers in the EU, enhancing treatment options for challenging cases.

The European Commission has approved Regeneron and Sanofi's Libtayo® (cemiplimab) for the first-line treatment of advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The approval is based on a Phase 3 trial showing Libtayo extends median overall survival by 8 months compared to chemotherapy and reduces the risk of death by 32%. Libtayo is now approved for three advanced cancers in the EU, with a consistent safety profile and no new safety signals reported.

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.