Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron Pharmaceuticals announced that the FDA expanded the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab), allowing it for post-exposure prophylaxis in high-risk individuals exposed to COVID-19. Phase 3 data showed an 81% reduction in symptomatic infections among close contacts. REGEN-COV is the only authorized COVID-19 antibody therapy for both treatment and prevention, retaining efficacy against key variants. The use of REGEN-COV is growing rapidly in the U.S. to combat ongoing outbreaks.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi have announced that Dupixent (dupilumab) has met primary and key secondary endpoints in a pivotal Phase 3 trial for chronic spontaneous urticaria (CSU). The study demonstrated a nearly twofold reduction in itch and urticaria activity at 24 weeks for patients receiving Dupixent alongside antihistamines. Approximately 300,000 people in the U.S. suffer from moderate-to-severe CSU. The trial showcased Dupixent’s well-established safety profile, with similar adverse events reported between Dupixent and placebo groups.

Regeneron Pharmaceuticals (NASDAQ: REGN) and AstraZeneca have formed a collaboration to research and commercialize small molecule compounds targeting the GPR75 gene, linked to obesity and related health issues. This partnership follows a significant discovery by Regeneron's Genetics Center, identifying genetic mutations associated with lower obesity risk. The companies will share research costs and potential profits equally. This initiative responds to the global obesity epidemic, which has drastically increased in prevalence, affecting approximately 650 million adults worldwide.

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.