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. develops and commercializes biotechnology medicines for serious diseases across eye disease, allergic and inflammatory conditions, cancer, cardiovascular and metabolic disease, neurological disease, hematologic conditions, infectious disease and rare disease. News about REGN commonly covers marketed products and pipeline programs such as EYLEA, EYLEA HD, Dupixent, Praluent, Libtayo, Kevzara, Otarmeni and investigational therapies developed through antibody, genetic medicine and RNA-based approaches.
Recurring company updates include financial results, FDA and European regulatory approvals, clinical trial data, label expansions, collaboration and licensing activity, product-access and pricing arrangements, share repurchase authorizations and corporate responsibility recognition. Regeneron's disclosures also frequently address its Sanofi collaboration around Dupixent and its use of proprietary technologies such as VelocImmune in drug discovery.
Regeneron (NASDAQ: REGN) announced that the European Medicines Agency accepted for review, under Accelerated Assessment, the Marketing Authorization Application for Otarmeni (lunsotogene parvec), an in vivo AAV gene therapy for biallelic OTOF variant-associated hearing loss.
The filing is backed by the pivotal CHORD trial, where 24 children (10 months–16 years) received a single intracochlear dose (10 unilateral, 14 bilateral). An earlier CHORD data cut (n=20) supported Otarmeni’s U.S. FDA accelerated approval in April 2026. If approved, it would be the first gene therapy for OTOF-related hearing loss in the EU. The condition affects about 46 newborns per year in the EU. Otarmeni is approved in the U.S.; outside the U.S., safety and efficacy have not been fully evaluated. Regulatory submissions are planned in additional markets, including Japan.
Regeneron (NASDAQ: REGN) reported preliminary Phase 1/2 LINKER-AL2 data for Lynozyfic (linvoseltamab) monotherapy in second-line-plus systemic AL amyloidosis. Among 20 patients (80 mg n=7; 240 mg n=13), all achieved hematologic responses and 100% at 240 mg reached complete response. Free light chains normalized by day 15, median time to hematologic CR was 47 days. Notable renal (73%) and cardiac (50%) improvements were observed, with no major organ deterioration. No dose-limiting toxicities occurred; all patients had treatment-emergent adverse events, including infections in 85%. The indication remains investigational and unapproved.
Regeneron (NASDAQ: REGN) announced a multi-target collaboration with Parabilis Medicines to develop Helicon™-based therapies, including Antibody-Helicon™ Conjugates (AHCs) for historically “undruggable” intracellular targets.
Parabilis receives $50M upfront, a $75M equity commitment, and is eligible for up to about $2.2B in milestones plus tiered royalties.
Regeneron (NASDAQ: REGN) reported top-line results from a Phase 3 trial of fianlimab + cemiplimab in first-line unresectable or metastatic melanoma. The study did not achieve statistical significance for the primary endpoint of progression-free survival versus pembrolizumab, despite a 5.1-month numeric median PFS increase with the high-dose combination.
Median PFS was 11.5 months for high-dose, 9.6 months for low-dose, 6.4 months for pembrolizumab, and 6.3 months for cemiplimab. No new safety signals were seen. A separate Phase 3 head-to-head trial versus Opdualag is ongoing, and the combination remains investigational.
Regeneron (NASDAQ:REGN) and Society for Science announced winners of the 2026 Regeneron International Science and Engineering Fair, the world’s largest pre-college STEM competition.
More than 1,700 students from over 67 countries received over $7 million in awards, with top prizes from $10,000 to $100,000 supporting education and continued research.
Regeneron (NASDAQ: REGN) was named to the Dow Jones Best-in-Class World Index for global responsibility and the Dow Jones Best-in-Class North America Index on May 8, 2026.
Regeneron is one of eight biotech firms globally and one of four U.S. biotech firms included, announced new 2030 science-led responsibility goals, and reaffirmed patient-access commitments including offering a novel gene therapy for congenital hearing loss for free in the United States. The company highlights a $300 million STEM funding pledge (2017–2036) and top-10% ESG rankings across major raters.
Regeneron (NASDAQ: REGN) and Sanofi reported Phase 4 REMODEL results showing Dupixent (dupilumab) improved esophageal function and reduced structural and histologic disease measures versus placebo in adult eosinophilic esophagitis (EoE) at week 24 presented at DDW on May 5, 2026.
Key findings: esophageal distensibility improved by 1.28 mm versus −0.01 mm placebo (placebo-corrected 1.30 mm; p<0.05); EREFS endoscopic score reduced by 4.89 points (placebo-corrected −4.96; p<0.0001); histologic remission rates and EoE-HSS scores also improved.
Regeneron (NASDAQ: REGN) reported Q1 2026 results: total revenue $3.605B (+19%), GAAP EPS $6.75 (includes $0.82 IPR&D charge) and non-GAAP EPS $9.47 (+15% non-GAAP diluted EPS). Key commercial and regulatory news: Dupixent global sales recorded by Sanofi $4.9B (+33%), EYLEA HD U.S. $468M (+52%), EYLEA HD FDA approval for up to 20-week dosing, Otarmeni gene therapy approved and to be provided free in the U.S., and a new $3.0B share repurchase authorization.
Operational headwinds included a Limerick manufacturing interruption affecting gross margin and pending PFS filling authorizations.
Regeneron (NASDAQ: REGN) reached an agreement with the U.S. government on April 23, 2026 to lower certain drug prices and expand access. Key terms include free U.S. access to Otarmeni, lowering Medicaid prices tied to other developed countries, aligning future U.S. prices to that country group, Praluent availability via TrumpRx.gov, three years of tariff relief, and a >$9 billion U.S. manufacturing and R&D investment commitment.
Regeneron (NASDAQ: REGN) announced FDA accelerated approval of Otarmeni (lunsotogene parvec-cwha), the first and only gene therapy for OTOF-related severe-to-profound sensorineural hearing loss, indicated for pediatric and adult patients with molecularly confirmed biallelic OTOF variants. Regeneron will provide Otarmeni for free in the U.S.
Approval was based on CHORD trial results showing 80% primary-endpoint responders at 24 weeks and 42% of evaluable participants achieving normal hearing at longer follow-up; continued approval may require confirmatory trial data.