In April 2026, Regeneron entered U.S. Government Agreements to provide certain wholly-owned products to Medicaid and price future U.S. medicines at Most-Favored-Nation Pricing, to participate in the TrumpRx.gov direct purchasing platform for Praluent, and to supply gene therapy Otarmeni free in the U.S.; in exchange, Regeneron's products are exempt from Section 232 pharmaceutical tariffs through January 2029 contingent on continued U.S. manufacturing and R&D investment. The agreements are expected to reduce prices and reimbursement for current and future products.
Clinical pipeline: Fianlimab + Libtayo Phase 3 in first-line metastatic melanoma did not reach statistical significance vs. pembrolizumab (May 2026), while the separate Phase 3 adjuvant melanoma study passed both pre-planned interim analyses and will continue to final readout in Q4 2026; Phase 2 fianlimab data in first-line advanced NSCLC did not support Phase 3 advancement. Itapekimab (COPD, CRSwNP, CRSsNP) and REGN7999 (TMPRSS6) were discontinued. EYLEA HD received FDA approval for dosing intervals up to 20 weeks in wAMD and DME and EC approval for RVO; the EYLEA HD pre-filled syringe (previously subject to an October 2025 CRL) remains in FDA review with the company targeting potential approval by end-2026. Otarmeni received FDA approval for OTOF hearing loss (EC MAA decision expected Q1 2027). Dupixent received new FDA/EC approvals for AFRS and pediatric CSU, and Japan MHLW approval for bullous pemphigoid, though Phase 3 lichen simplex chronicus studies missed primary endpoints. FDA lifted the clinical hold on nex-z (CRISPR/Cas9 TTR knockout) Phase 3 trials in ATTR-CM and ATTRv-PN. Garetosmab FOP BLA PDUFA date is August 2026; cemdisiran gMG NDA decision is expected November 2026.
As of June 30, 2026, Regeneron's Sanofi collaboration development balance (its obligation to reimburse Sanofi for previously funded development expenses) was fully repaid and will no longer reduce reported Sanofi collaboration revenue beginning in Q3 2026, mechanically increasing future collaboration revenue recognized from Dupixent/Kevzara profit shares. Q2 2026 Sanofi collaboration revenue was $2,174.3M (up from $1,443.6M in Q2 2025), driven primarily by higher Dupixent global sales of $5,998.2M (up 38% YoY).
Regeneron added two new collaboration partners in 2026: a January 2026 agreement with Tessera Therapeutics for alpha-1 antitrypsin deficiency (TSRA-196), under which Regeneron made $150M in aggregate payments (upfront plus Tessera preferred stock) in Q1 and will lead global development and commercialization after Tessera's first-in-human trial; and a May 2026 agreement with Parabilis Medicines for its Helicon peptide platform, with a $50M upfront payment plus $75M in Parabilis common stock, under which Regeneron will lead development. Acquired IPR&D charges totaled $127.0M in Q2 and $228.9M in H1 2026, reflecting these and other collaboration/licensing upfront and opt-in payments. The Alnylam RNAi target nomination period and the Intellia target selection right both expired (May 2026 and April 2026, respectively).
Bulk manufacturing at the Limerick, Ireland facility was temporarily interrupted in Q1 2026 due to unanticipated facility repairs; production returned to normal levels by June 30, 2026, and the interruption did not affect product availability. The disruption depressed gross margin on net product sales to 78% in Q2 2026 (vs. 83% in Q2 2025) due to unabsorbed manufacturing costs. Full-year 2026 capital expenditures are guided at $1.030–$1.100B, including expansion at Tarrytown, NY and development of the Saratoga Springs, NY property for additional manufacturing capacity and production support.
EYLEA U.S. net product sales declined 45% to $412.2M in Q2 2026 (from $754.3M in Q2 2025) amid ongoing biosimilar competition (Amgen's Pavblu launched in the U.S.) and continued patient transition to EYLEA HD, which grew 52% to $596.3M; combined EYLEA HD + EYLEA U.S. sales fell 21% to $1,008.5M. Global Libtayo sales rose 30% to $489.4M, and newly launched Lynozyfic (linvoseltamab, relapsed/refractory multiple myeloma) recorded $16.5M in Q2 2026 net product sales. A new $3.0B share repurchase authorization was approved in April 2026; $1,164.5M was repurchased in Q2, leaving $2.534B available.
(Filed on April 29, 2026)
+19.0%
—
$3B
EYLEA HD pre-filled syringe: Regeneron resubmitted its FDA application for filling at Catalent Indiana following a recent FDA site re-inspection; the FDA did not act by the April 2026 PDUFA date on a second contract manufacturer application, leaving both pending. The company anticipates a regulatory decision on one or both applications during Q2 2026. Separately, bulk manufacturing at the Limerick, Ireland facility was temporarily interrupted in Q1 2026 due to unanticipated facility repairs; initial production resumed in Q2 2026, and gross margin on net product sales fell to 76% (from 81% in Q1 2025) primarily due to unabsorbed manufacturing costs and higher inventory write-offs. The company expects production to return to normal by end of Q2 2026 and states the interruption has not impacted product availability.
U.S. Government Agreements (announced April 2026): Regeneron agreed to provide certain wholly-owned U.S. products to Medicaid at or below Most-Favored-Nation Pricing, to price certain future U.S. medicines at or below MFN, to participate in the TrumpRx.gov direct-purchasing platform for Praluent, and to provide the gene therapy Otarmeni (lunsotogene parvec) free in the U.S. In exchange, Regeneron's products are exempt from Section 232 pharmaceutical tariffs (effective July 31, 2026) through January 2029, contingent on continued U.S. manufacturing and R&D infrastructure investment.
EYLEA biosimilar patent litigation: In Q1 2026, Regeneron settled with Samsung Bioepis (Feb 11), precluding Samsung's aflibercept 2 mg biosimilar launch in the U.S. until January 2027, and with Formycon (Feb 23) and Bayer, permitting Formycon to launch in the U.K. immediately and in the rest of Europe from May 2026. In Japan, a settlement with Fuji Pharma (Jan 28) dismissed the pending lawsuit. In Europe, the EPO Opposition Division invalidated the '049 Patent on April 21, 2026, while in Germany the Munich Regional Court granted a preliminary injunction against Sandoz in January 2026 that was subsequently suspended on appeal; Regeneron filed a new infringement suit against Sandoz (Mar 31) and Sam Chun Dang (Apr 1) in the Munich court. Additional U.S. EYLEA biosimilars are expected to launch in the second half of 2026.
New collaboration with Tessera Therapeutics (effective January 2026): Regeneron entered a co-development and co-commercialization agreement for TSRA-196, Tessera's investigational program for alpha-1 antitrypsin deficiency. Tessera leads the initial first-in-human trial; Regeneron will lead subsequent global development and commercialization, with worldwide development expenses and future profits/losses shared equally. Regeneron made aggregate payments of $150.0 million in Q1 2026 (up-front payment plus purchase of Tessera preferred stock), contributing to $101.9 million in acquired IPR&D expense for the quarter.
Clinical and regulatory milestones in Q1 2026: FDA approved Otarmeni (AAV gene therapy) for OTOF-associated hearing loss and approved EYLEA HD for RVO and extended dosing intervals (up to 20 weeks) in wAMD and DME; the EC approved EYLEA HD for RVO. Dupixent received FDA approvals for allergic fungal rhinosinusitis and pediatric CSU, and Japanese MHLW approval for bullous pemphigoid. For fianlimab, Phase 2 data in first-line advanced NSCLC did not support advancement to Phase 3, but the Phase 3 adjuvant melanoma study passed its first IDMC interim analysis and will continue. The FDA removed a clinical hold on Phase 3 trials of nex-z (CRISPR/Cas9 TTR gene knockout) in ATTR-CM and ATTRv-PN. Garetosmab (FOP) has an FDA BLA PDUFA date of August 2026. Cemdisiran for myasthenia gravis had an NDA submitted using a Rare Pediatric Disease Priority Review Voucher, with an FDA decision expected in Q4 2026.
Product sales and pipeline commercialization: EYLEA HD U.S. net product sales rose 53% to $468.4M (from $306.8M), now representing 50% of combined EYLEA HD/EYLEA U.S. sales, while EYLEA U.S. sales fell 36% to $473.1M due to biosimilar competition (including Amgen's Pavblu, launched after May 2024 exclusivity expiration) and patient transition to EYLEA HD. Libtayo global sales grew 54% to $438.2M. Dupixent global sales (recorded by Sanofi) increased 33% to $4,880.1M, driving Regeneron's Sanofi collaboration revenue to $1,605.1M (up 36% YoY). Lynozyfic (linvoseltamab) generated $11.2M in its first quarter of reported sales. Full-year 2026 capital expenditures are guided at $1.1–$1.2 billion, including expansion of the Tarrytown, N.Y. headquarters and manufacturing facilities, including development of the Saratoga Springs, N.Y. property for production support and additional manufacturing capacity.
(Filed on February 4, 2026)
+2.5%
—
$3.1B
EYLEA HD Q4 regulatory: FDA issued a Complete Response Letter on October 27 for the pre-filled syringe sBLA, citing unresolved findings from a July 2025 Catalent Indiana site inspection (Catalent also received an OAI letter in October). In November, FDA approved EYLEA HD for RVO and an every-4-week dosing regimen across approved indications; in December, FDA approved a new manufacturer for EYLEA HD vial filling. In December, Regeneron filed a new PFS application using an alternate manufacturer; FDA decision is expected in Q2 2026.
Annual EYLEA sales pressure: Full-year 2025 EYLEA U.S. net product sales declined 42% to $2,748M (vs. $4,767M in 2024), driven by biosimilar competition (Amgen Pavblu launched Q4 2024), market share loss to compounded bevacizumab due to patient affordability constraints, and patient transition to EYLEA HD. EYLEA HD U.S. sales grew 36% to $1,637M. Combined EYLEA HD + EYLEA U.S. represented 31% of total 2025 revenues (vs. 42% in 2024). Dupixent global net product sales grew to $17,807M (from $14,148M in 2024), driving Sanofi collaboration revenue to $5,884M (41% of total revenues).
Annual 2025 pipeline milestones: Itepekimab Phase 3 COPD results were mixed—AERIFY-1 met its primary endpoint (27% reduction in moderate/severe exacerbations vs. placebo) while AERIFY-2 did not; the company and Sanofi are evaluating next steps. Garetosmab Phase 3 in FOP met its primary endpoint (BLA/MAA decisions expected H2 2026). Cemdisiran Phase 3 in myasthenia gravis met primary and key secondary endpoints (NDA submission expected Q1 2026). Fianlimab/cemiplimab first-line NSCLC interim analysis (April 2025) supported continuation of the Phase 2 portion unchanged, with a Phase 3 go/no-go decision expected H1 2026. REGN5713-5715 (birch allergy) and REGN1908-1909 (cat allergy) Phase 3 trials met primary endpoints; second Phase 3 trials initiated or planned for 2026.
Hematology and oncology: Lynozyfic (linvoseltamab) received FDA and EC approval for relapsed/refractory multiple myeloma in 2025 and completed enrollment in the LINKER-MM3 confirmatory Phase 3 trial. Ordspono (odronextamab) received an FDA CRL for relapsed/refractory follicular lymphoma in July 2025, also impacted by the Catalent inspection. Libtayo (cemiplimab) received FDA and EC approval for adjuvant CSCC in 2025, supported by positive Phase 3 data presented at ASCO and published in NEJM. DB-OTO (otoferlin gene therapy) had updated Phase 1/2 data published in NEJM and received an FDA Commissioner's National Priority Voucher; BLA decision expected H1 2026.
In-licensing and partnerships: In July 2025, Regeneron acquired development and commercial rights outside mainland China, Hong Kong, and Macau to HS-20094 (a dual GLP-1/GIP receptor agonist in Phase 3 in China) from Hansoh for an $80M upfront payment plus milestones and a low double-digit royalty, enabling combination studies with its own obesity/metabolic assets. In January 2026, a collaboration with Tessera Therapeutics for TSRA-196 (alpha-1 antitrypsin deficiency) became effective, with Regeneron making $150M in aggregate payments (upfront + preferred stock) and sharing development expenses and future profits equally.
EYLEA biosimilar settlements reshaping competitive timeline: In 2025, U.S. settlements with Mylan/Biocon, Sandoz/Formycon, and Celltrion preclude aflibercept 2 mg biosimilar launches until H2 2026, Q4 2026, and December 2026, respectively. On December 13, 2025, Regeneron and Bayer settled with Biocon outside the U.S., permitting UK launch in January 2026 and other markets in March 2026. In January 2026, settlements with Celltrion, Alvotech, and Samsung Bioepis (outside U.S.) permit phased launches from January through May 2026. Additional biosimilar versions of EYLEA are expected to launch in the U.S. in H2 2026, which management notes may further negatively impact EYLEA/EYLEA HD sales.
(Filed on October 28, 2025)
+0.9%
—
$2.5B
EYLEA U.S. net product sales declined 41% in Q3 2025 to $681M (from $1,145M a year prior), driven by biosimilar competition (Amgen's Pavblu launched Q4 2024), loss of market share to compounded bevacizumab due to patient affordability constraints, and ongoing patient transition to EYLEA HD. EYLEA HD U.S. sales grew 10% to $431M. In August 2025 the FDA extended target action dates for EYLEA HD applications (pre-filled syringe, every-4-week dosing, RVO) after a July 2025 inspection at Catalent Indiana; on October 27, 2025 (post-quarter), the FDA issued a CRL for the EYLEA HD pre-filled syringe sBLA citing unresolved Catalent inspection findings, with the company planning to submit a new filler by January 2026. FDA decisions on the RVO and every-4-week dosing sBLAs remain expected in November 2025.
The FDA issued a Complete Response Letter on July 30, 2025 for the Ordspono (odronextamab) BLA in relapsed/refractory follicular lymphoma, also impacted by the Catalent Indiana site inspection. Separately, Intellia temporarily paused dosing and screening in the Phase 3 Nex-z (NTLA-2001) CRISPR/Cas9 trials in ATTR-CM and ATTRv-PN due to a Grade 4 liver-related adverse event.
In July 2025, Regeneron in-licensed HS-20094 (a dual GLP-1/GIP receptor agonist in Phase 3 in China) from Hansoh Pharmaceuticals, paying an $80M up-front amount for development and commercial rights outside mainland China, Hong Kong, and Macau, to enable combination studies with Regeneron products addressing muscle loss and obesity comorbidities. The company also recorded a $44.5M tax charge in Q3 related to re-measurement of U.S. net deferred tax assets following enactment of the One Big Beautiful Bill Act.
Dupixent (Sanofi collaboration) global net product sales reached $4,857M in Q3 2025 (+27% YoY), with Regeneron's share of collaboration profits at $1,456M; Libtayo global sales rose 27% to $365M. In May 2025, Phase 3 itepekimab COPD trial AERIFY-1 met its primary endpoint (27% exacerbation reduction) while AERIFY-2 did not; the company and Sanofi are evaluating next steps. Additional pipeline milestones: cemdisiran Phase 3 in myasthenia gravis met primary and key secondary endpoints (NDA planned Q1 2026), garetosmab Phase 3 in FOP met its primary endpoint (BLA planned Q4 2025), and DB-OTO gene therapy for otoferlin-related hearing loss received an FDA Commissioner's National Priority Voucher (BLA planned Q4 2025).
Regeneron reached multiple EYLEA biosimilar patent settlements in 2025 that preclude competitor launches: Biocon (H2 2026), Formycon (Q4 2026), Sandoz (Q4 2026), and Celltrion (Dec 31, 2026). In June 2025 the USPTO denied all three IPR petitions (Samsung, Formycon, Celltrion) challenging the key '865 Patent, though Fresenius Kabi filed new IPR petitions in July 2025. In the UK, the High Court upheld the '691 Patent but invalidated the '306 Patent and found no infringement; in Germany, the Munich Regional Court granted a permanent injunction against Formycon's biosimilar in October 2025.
In May 2025, a jury awarded Regeneron $406.8M in damages ($135.6M compensatory, $271.2M punitive) on 9 of 10 counts in its antitrust lawsuit against Amgen alleging an exclusionary bundling scheme against Praluent; post-trial motions were heard in August 2025. Regeneron also initiated a lawsuit against Sanofi (filed November 2024) alleging breach of the Antibody Collaboration Agreement regarding commercialization information access and audit rights; Sanofi moved to dismiss in July 2025. Q3 2025 R&D expense was $1,475M (+16% YoY), and average headcount rose to 15,301.
