Regeneron Pharmaceuticals Stock Price, News & Analysis

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.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced significant five-year follow-up results from the Phase 3 EMPOWER-Lung 3 trial for Libtayo® (cemiplimab) plus chemotherapy in advanced non-small cell lung cancer (NSCLC). The combination therapy demonstrated a 19.4% five-year overall survival rate, more than double the 8.8% rate with chemotherapy alone.

Key findings include a 21.1-month median overall survival versus 12.9 months for chemotherapy alone, representing a 34% reduction in death risk. The treatment showed particular efficacy in squamous NSCLC patients, achieving a 22.3-month median overall survival. The objective response rate was 43.6% compared to 22.1% for chemotherapy alone, including a 6.4% complete response rate.

The safety profile remained consistent with previous reports, with adverse events occurring in 96.5% of Libtayo plus chemotherapy patients.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 3 trial results for its first-in-class allergen-blocking antibodies targeting cat and birch allergies. The trials demonstrated significant symptom reduction compared to placebo.

In the cat allergy trial, a single dose of REGN1908/REGN1909 reduced itch by 52%, conjunctival redness by 39%, and skin prick reactivity by 44%. For birch allergy, REGN5713/REGN5715 showed similar efficacy with 51% itch reduction, 46% conjunctival redness reduction, and 44% decrease in skin prick reactivity.

Both treatments showed rapid onset within 8 days and durability lasting over 3 months. The company plans additional Phase 3 development, with cat allergy trials starting in H1 2026 and birch allergy trials by year-end.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced an updated presentation time for the Morgan Stanley 23rd Annual Global Healthcare Conference. The company will now present at 7:00 a.m. ET on Monday, September 8, 2025.

The presentation will be accessible through a live webcast on Regeneron's investor relations website, with replays and transcripts remaining available for at least 30 days after the event.

Regeneron (NASDAQ: REGN) announced positive Phase 3 NIMBLE trial results for cemdisiran monotherapy in treating generalized myasthenia gravis (gMG). The trial met its primary and key secondary endpoints, with cemdisiran showing a 2.3-point placebo-adjusted improvement in MG-ADL total score.

Cemdisiran, administered subcutaneously every three months, demonstrated 74% inhibition of complement activity. The trial also tested a cemdisiran-pozelimab combination, achieving 99% inhibition, though cemdisiran monotherapy showed numerically better results. Key efficacy metrics include 76.6% of patients achieving ≥3-point MG-ADL reduction and 48.4% achieving ≥5-point QMG reduction.

The safety profile was favorable, with no meningococcal infections and no treatment discontinuations due to adverse events in the cemdisiran arm. Regeneron plans U.S. regulatory submission in Q1 2026.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced FDA review extensions for two EYLEA HD® (aflibercept) 8 mg regulatory submissions to Q4 2025. The extensions affect the prefilled syringe CMC Prior-Approval Supplement and a supplemental Biologics License Application for RVO treatment and expanded dosing options.

The delay stems from a recent FDA inspection of Catalent Indiana LLC, a third-party manufacturer acquired by Novo Nordisk. Novo Nordisk submitted a comprehensive response in August 2025 to address FDA observations. EYLEA HD remains available in vial form, with approved dosing intervals of 8-16 weeks for wAMD and DME patients, and 8-12 weeks for DR patients after initial monthly doses.