Regeneron Pharmaceuticals Stock Price, News & Analysis

Regeneron (NASDAQ: REGN) announced that the EMA CHMP issued a positive opinion for Libtayo (cemiplimab) as adjuvant treatment for adult cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation on Oct 17, 2025.

The decision is supported by Phase 3 C-POST results: risk of recurrence or death −68% (HR 0.32; 95% CI 0.20–0.51; p<0.0001). Locoregional recurrence was 4% vs 17% and distant recurrence 5% vs 13% (Libtayo vs placebo). Detailed data published in NEJM May 2025. European Commission final decision expected in the coming months.

Safety: AEs 91% vs 89%; Grade ≥3 AEs 24% vs 14%; discontinuation 10% vs 2%; two deaths per arm.

Regeneron (NASDAQ: REGN) will present seven abstracts at ESMO 2025 (Oct 17-21) highlighting advances across its oncology portfolio and pipeline.

Key highlights include new Phase 3 C-POST data showing safety and pharmacokinetics for a patient-focused every-6-week adjuvant dosing option of Libtayo (cemiplimab) in high-risk cutaneous squamous cell carcinoma (CSCC), with efficacy, pharmacokinetics and immunogenicity reported as similar between every-3-week and every-6-week regimens. The C-POST data recently supported FDA approval of Libtayo for adjuvant treatment in adult CSCC patients at high risk of recurrence after surgery and radiation.

Regeneron (NASDAQ: REGN) reported updated pivotal CHORD trial results for investigational gene therapy DB-OTO for profound OTOF-related hearing loss, published in New England Journal of Medicine and presented at AAO-HNSF on Oct 12, 2025.

Key findings: 11 of 12 participants had clinically meaningful hearing improvements; 3 achieved normal hearing sensitivity; trial met primary endpoint with 9 participants ≤70 dBHL at week 24; auditory brainstem response achieved in 9 participants; stability or continued improvement observed up to 72 weeks. No DB-OTO-related adverse findings reported. U.S. regulatory submission planned later in 2025, pending FDA discussions.

Regeneron (NASDAQ: REGN) announced FDA approval of Libtayo (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, approved Oct 8, 2025.

Approval was based on Phase 3 C-POST results showing a 68% reduction in risk of disease recurrence or death versus placebo (HR 0.32; 95% CI 0.20-0.51; p<0.0001). Safety was consistent with known Libtayo monotherapy risks; serious adverse reactions occurred in 18% of patients. An EU decision is expected by H1 2026.

Regeneron Pharmaceuticals (NASDAQ: REGN) has scheduled its third quarter 2025 financial and operating results announcement for Tuesday, October 28, 2025, before U.S. market opening. The company will host a conference call and webcast at 8:30 AM Eastern Time on the same day.

Investors can access the event through a webcast on Regeneron's investor relations website. For telephone participation, advance registration is required through a provided link. A replay and transcript will be available on the company's website for at least 30 days following the event.

Regeneron Pharmaceuticals (NASDAQ: REGN) has received FDA approval to extend the use of Evkeeza® (evinacumab-dgnb) to children as young as 1 year old with homozygous familial hypercholesterolemia (HoFH), an ultra-rare form of high cholesterol.

The approval builds upon Evkeeza's initial 2021 authorization for adults and adolescents aged 12 and older, and its 2023 expansion to children aged 5-11. The drug, when used with standard lipid-lowering therapies, has demonstrated the ability to lower LDL-C levels by approximately 50% compared to placebo.

HoFH affects about 1,300 people in the U.S. and can lead to dangerously high cholesterol levels exceeding 400 mg/dL. The expanded indication was supported by clinical data from 6 children, with no new safety concerns identified.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced a significant humanitarian initiative, pledging to donate up to 500 doses of Inmazeb®, their FDA-approved Ebola treatment, to the World Health Organization (WHO). The donation targets low and lower-middle income countries most at risk of Ebola outbreaks.

Inmazeb®, which combines atoltivimab, maftivimab, and odesivimab-ebgn, was the first FDA-approved treatment for Orthoebolavirus zairense (Zaire ebolavirus). The company is currently expediting supplies to the Democratic Republic of Congo (DRC) to address an ongoing outbreak. Through June 2025, 266 patients have received treatment under Regeneron's compassionate use protocol.

Regeneron Pharmaceuticals (NASDAQ: REGN) has presented complete 26-week results from its Phase 2 COURAGE trial at EASD, investigating combinations of semaglutide with trevogrumab for obesity treatment. The study demonstrated that adding trevogrumab could prevent approximately 50% of lean mass loss associated with semaglutide-induced weight loss.

Key findings show that while 33% of semaglutide-induced weight loss was from lean mass loss, the combination therapy achieved better body composition outcomes. The triplet combination (including garetosmab) showed the most significant results with only 7.4% lean mass loss and 92.6% fat mass loss. All treatment groups demonstrated numerical improvements in metabolic and lipid parameters.

The combinations were generally well-tolerated, though the triplet therapy group experienced higher discontinuation rates and two deaths occurred, which haven't been causally linked to the treatment.

Regeneron (NASDAQ: REGN) announced breakthrough results from its Phase 3 OPTIMA trial for garetosmab in treating fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder. The trial met its primary endpoint, demonstrating that garetosmab reduced new bone lesions by 90-94% and achieved a greater than 99% reduction in total lesion volume compared to placebo.

The study involved 63 adult FOP patients who received either placebo or garetosmab (3 mg/kg or 10 mg/kg) every four weeks. Both dosing regimens showed high efficacy, with the 10 mg/kg dose reducing flare-ups by 89%. Based on these positive results, the Independent Data Monitoring Committee recommended transitioning placebo patients to garetosmab treatment. Regeneron plans to submit for U.S. regulatory approval by year-end 2025.