Welcome to our dedicated page for Regeneron Pharmaceuticals news (Ticker: REGN), a resource for investors and traders seeking the latest updates and insights on Regeneron Pharmaceuticals stock.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) regularly issues news on its medicines, clinical programs and corporate developments across multiple therapeutic areas. As a biotechnology company focused on serious diseases, Regeneron’s announcements often cover advances in eye care, allergic and inflammatory diseases, oncology, hematology, cardiovascular disease, infectious disease and rare conditions.
News about Regeneron frequently highlights regulatory milestones for its marketed products. Recent examples include approvals for Dupixent (dupilumab) in additional indications and age groups, such as chronic spontaneous urticaria in the European Union and bronchial asthma in children in Japan, as well as expanded indications and dosing flexibility for EYLEA HD (aflibercept) Injection 8 mg in retinal diseases. The company also reports on new approvals for Libtayo (cemiplimab), including adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation in the European Union.
Investors and healthcare professionals can expect updates on Regeneron’s oncology and hematology pipeline, including data from trials of Lynozyfic (linvoseltamab) in multiple myeloma and odronextamab in B‑cell non‑Hodgkin lymphomas, as well as programs in paroxysmal nocturnal hemoglobinuria and severe aplastic anemia. Regeneron often presents such data at major medical meetings, and issues press releases summarizing efficacy and safety results.
Corporate and R&D collaboration news is another recurring theme. The company has announced partnerships such as its global collaboration with Tessera Therapeutics on TSRA‑196, an investigational in vivo gene editing therapy for alpha‑1 antitrypsin deficiency, and provides updates on its factor XI antibody program for anticoagulation. Regeneron also communicates scheduling of quarterly and annual financial results webcasts and investor events, including its ‘Regeneron Roundtable’ series.
This news page aggregates these types of updates so readers can follow product approvals, late-stage trial readouts, scientific presentations, strategic collaborations and financial reporting dates related to REGN. For ongoing research and investment analysis, checking this feed regularly can provide timely insight into Regeneron’s progress across its broad portfolio.
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.
Regeneron Pharmaceuticals (NASDAQ: REGN) has announced its participation in four major healthcare investor conferences in September 2025. The company will present at the Cantor Global Healthcare Conference (Sept 3), Wells Fargo Healthcare Conference (Sept 4), Morgan Stanley Global Healthcare Conference (Sept 8), and Bernstein Healthcare Forum (Sept 24).
All presentations will be accessible via webcast through Regeneron's investor relations website, with replays and transcripts available for at least 30 days after the events.
Regeneron (NASDAQ:REGN) reported strong Q2 2025 financial results with total revenues increasing 4% to $3.68 billion. Key highlights include Dupixent global sales growth of 22% to $4.34 billion and EYLEA HD U.S. sales growth of 29% to $393 million, though total EYLEA franchise sales decreased 25% to $1.15 billion.
The quarter saw significant regulatory achievements, including FDA approvals for Lynozyfic in multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria. The company reported GAAP EPS of $12.81 (up 3%) and non-GAAP EPS of $12.89 (up 12%).
Notable pipeline progress includes positive obesity trial results, manufacturing challenges affecting EYLEA HD approvals, and a strategic in-licensing deal for a late-stage GLP-1/GIP receptor agonist. The company returned over $2.3 billion to shareholders through share repurchases and dividends.
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