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 (NASDAQ: REGN) will present new and updated hematology data across 14 abstracts at the American Society of Hematology (ASH) Annual Meeting, December 6–9, 2025 in Orlando.
Key highlights include an oral presentation of Lynozyfic (linvoseltamab) as the first BCMAxCD3 bispecific monotherapy evaluated in newly diagnosed multiple myeloma (LINKER-MM4), multiple linvoseltamab combination updates (LINKER-MM2), and six odronextamab abstracts including first results from OLYMPIA-3 (DLBCL) and early OLYMPIA-2/5 follicular lymphoma data. Additional presentations cover cemdisiran+pozelimab in PNH and first-in-human REGN7257 in severe aplastic anemia. Regeneron will host a virtual investor roundtable on Dec 10, 2025 at 8:30 a.m. ET to discuss its multiple myeloma program.
Regeneron (NASDAQ: REGN) reported positive Phase 2 proof-of-concept results for two investigational factor XI antibodies, REGN7508Cat and REGN9933A2, from trials in total knee replacement patients presented Nov 8, 2025.
Both antibodies lowered postoperative VTE versus historical placebo; REGN7508Cat reduced VTE to 7.1% and REGN9933A2 to 17.2%. REGN7508Cat vs enoxaparin showed a risk difference of -13.6% (95% CI -21.1% to -6.0%). No major or clinically relevant non-major bleeding occurred in any arm. Phase 3 programs have been initiated and an investor roundtable is scheduled for Nov 10, 2025 at 8:30 a.m. ET.
Regeneron (NASDAQ: REGN) announced positive Phase 3 results for Dupixent in allergic fungal rhinosinusitis (AFRS) and an FDA acceptance of the supplemental BLA for Priority Review with a target action date of February 28, 2026. The 62-patient LIBERTY-AFRS-AIMS trial met all primary and secondary endpoints, showing large improvements versus placebo in sinus opacification, nasal congestion and nasal polyp size at 24 and 52 weeks.
Key numeric results include a 50.0% reduction in sinus opacification vs 9.8% placebo at 52 weeks (7.36-point placebo-corrected; p<0.0001) and a 92% lower risk of systemic steroid use or surgery over 52 weeks.
Regeneron (NASDAQ: REGN) will webcast management presentations at multiple investor conferences in November–December 2025. Scheduled webcasts: Jefferies London Healthcare Conference on Nov 17, 2025 at 3:30 p.m. GMT (10:30 a.m. ET); Wolfe Research Healthcare Conference on Nov 17, 2025 at 9:20 a.m. ET; Evercore Healthcare Conference on Dec 2, 2025 at 1:20 p.m. ET; and Citi Global Healthcare Conference on Dec 3, 2025 at 10:30 a.m. ET.
Sessions can be accessed from Regeneron’s Investors & Media events page and replays and transcripts will be archived on the company website for at least 30 days.
Regeneron (NASDAQ: REGN) announced that Dupixent (dupilumab) won the 2025 Prix Galien USA Best Biotechnology Product award for its scientific innovation and clinical impact.
Dupixent targets the IL-4/IL-13 pathway, is the first FDA-approved dual blocker (approved 2017), is approved for eight indications globally, and had a 2024 FDA approval as an add-on maintenance treatment for adults with inadequately controlled COPD with an eosinophilic phenotype. The company says >1 million patients are currently treated with Dupixent worldwide. Common side effects listed include injection site reactions, eye inflammation, eosinophilia, upper respiratory infections, and others.
Regeneron (NASDAQ: REGN) reported Q3 2025 total revenues of $3.75 billion (+1%), GAAP EPS of $13.62 and non-GAAP EPS of $11.83 (includes a $0.68 headwind from an acquired IPR&D charge).
Dupixent global net sales (recorded by Sanofi) rose 27% to $4.86 billion. EYLEA HD U.S. net sales increased 10% to $431 million, while total EYLEA U.S. sales fell 28% to $1.11 billion. Libtayo global sales were $365 million (+26%).
Key developments: FDA approved Libtayo for adjuvant high‑risk CSCC; DB‑OTO received a Commissioner’s National Priority Voucher and pivotal DB‑OTO and garetosmab filings are planned in Q4 2025; an FDA Complete Response Letter cited Catalent inspection issues for an EYLEA HD sBLA. Capital actions include $663M of Q3 repurchases and a declared dividend of $0.88 per share.
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.