Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

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.