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 (NASDAQ: REGN) is a leading biotechnology innovator developing transformative treatments for serious diseases through advanced platforms like VelociSuite®. This page serves as the definitive source for official company announcements, research milestones, and therapeutic developments.
Investors and medical professionals will find curated updates including FDA approvals, clinical trial results, partnership announcements, and financial reports. Our aggregation ensures timely access to Regeneron's progress in oncology, immunology, rare diseases, and ophthalmic therapies.
All content is sourced directly from Regeneron's communications and verified financial disclosures. Bookmark this page to monitor the company's pipeline advancements, regulatory updates, and strategic collaborations that drive biopharmaceutical innovation.
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.
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.
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