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 report fourth quarter and full year 2025 financial and operating results on Friday, January 30, 2026, released before U.S. markets open.
The company will host a conference call and simultaneous webcast on January 30, 2026 at 8:30 AM Eastern Time. Investors may join the live webcast via Regeneron’s Investors and Media web page or register in advance to participate by telephone and receive dial-in details, a unique passcode, and registrant ID.
A replay and transcript will be archived on the company website for at least 30 days.
Regeneron (NASDAQ: REGN) and Sanofi announced that Japan's Ministry of Health, Labour and Welfare approved Dupixent (dupilumab) for children aged 6 to 11 years with severe or refractory bronchial asthma inadequately controlled by existing therapy, expanding prior approval for ages 12 and up.
Approval was supported by the global Phase 3 VOYAGE program and the EXCURSION extension, where Dupixent added to standard care reduced severe exacerbations 54%–65% and improved lung function 4.68%–5.32% versus placebo; a Japanese pediatric sub-study showed improved lung function at 12 weeks and low annual exacerbation rates.
Regeneron (NASDAQ: REGN) will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026.
The live webcast is scheduled for 2:15 p.m. Pacific Time / 5:15 p.m. Eastern Time and can be accessed from the company’s Investors & Media page at http://investor.regeneron.com/events-and-presentations. A replay and transcript will be archived on the company website for at least 30 days.
Regeneron (NASDAQ: REGN) reported encouraging Phase 1/2 LINKER-MM4 data for Lynozyfic (linvoseltamab) monotherapy in newly diagnosed multiple myeloma presented at ASH on Dec 7, 2025. Across 45 treated patients (50/100/200 mg), median time to response was 1.2 months and all dose groups achieved VGPR+ ≥70% with limited follow-up. Of 20 MRD-evaluable VGPR+ patients, 95% (19 of 20) were MRD negative at 10-5 sensitivity. Common TEAEs included CRS (all Grade 1) 44%, neutropenia any Grade 38% (Grade 3/4 33%), and infections in 84% (Grade 3 33%). No Grade 5 TEAEs or dose-limiting toxicities were reported.
The program will continue with a Phase 2 expansion and combination studies in earlier lines.
Regeneron (NASDAQ:REGN) and Tessera Therapeutics announced a global collaboration to develop TSRA-196, an investigational one-time gene editing therapy for alpha-1 antitrypsin deficiency (AATD).
Key points: Tessera will receive $150 million (cash upfront plus equity) and is eligible for $125 million in near/mid-term milestones; the companies will share development costs and future profits 50:50. Tessera expects to file an IND and CTA submissions by year-end. Preclinical data showed durable SERPINA1 editing in mice and non-human primates with high liver specificity and no off-target signal reported. The agreement is subject to customary closing conditions, including HSR antitrust clearance.
Regeneron (NASDAQ: REGN) and Sanofi announced on November 25, 2025 that the European Commission approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria (CSU) in patients aged 12+ with inadequate response to H1 antihistamines who are naïve to anti-IgE therapy.
Approval is based on the LIBERTY-CUPID Phase 3 program: two pivotal trials (Study A and Study C, combined n=284) and an additional safety study (Study B, n=108) showing significant reductions in itch and hives at 24 weeks, higher rates of well-controlled disease and complete response, and a safety profile consistent with prior Dupixent indications. Approximately 270,000 EU patients may be eligible.
Regeneron (NASDAQ: REGN) announced FDA approval of EYLEA HD (aflibercept) Injection 8 mg on November 19, 2025, for treatment of macular edema following retinal vein occlusion (RVO) with dosing up to every 8 weeks after an initial monthly period.
The FDA also approved a monthly (every 4-week) dosing option across approved indications (wAMD, DME, DR, RVO). Approval for RVO was based on the Phase 3 QUASAR trial, which met its primary endpoint at 36 weeks showing non-inferior visual acuity gains versus EYLEA 2 mg dosed every 4 weeks.
Regeneron (NASDAQ: REGN) announced on November 19, 2025 that the European Commission approved Libtayo (cemiplimab) as the first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
The approval is based on the Phase 3 C-POST trial where Libtayo reduced risk of recurrence or death by 68% (HR 0.32; 95% CI 0.20-0.51; p<0.0001). Safety was consistent with prior use; grade ≥3 adverse events occurred in 24% vs 14% for placebo, and treatment discontinuation rates were 10% vs 2%.
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.