Regeneron reports Q2 2026 results, cemdisiran filings accepted, fianlimab trial misses
Regeneron's second-quarter release recaps June 2026 FDA and EMA acceptance of cemdisiran filings for generalized myasthenia gravis and a Phase 3 fianlimab trial that missed its primary endpoint.
Regeneron Pharmaceuticals reported second quarter 2026 results on July 30, 2026, alongside a business update covering several pipeline and regulatory developments from earlier in the quarter.
In June 2026, the company announced that both the FDA and EMA had accepted regulatory applications for cemdisiran, a C5 RNAi therapy, to treat adult patients with generalized myasthenia gravis. The FDA is reviewing the New Drug Application under priority review, with a target action date in November 2026 following use of a Priority Review Voucher, while a European Commission decision is anticipated in the second half of 2027.1
On the oncology side, the company announced in May 2026 results from a Phase 3 trial evaluating two dose levels of fianlimab in combination with cemiplimab as first-line treatment for unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for its primary endpoint of progression-free survival compared to pembrolizumab monotherapy.1
Other pipeline updates included positive results from the Phase 1/2 LINKER-AL2 trial for Lynozyfic (linvoseltamab) in second-line-plus systemic amyloid light chain amyloidosis, presented at the ASCO 2026 Annual Meeting, with a Phase 2 portion intended for registration now underway1, and the initiation of a Phase 3 study in peripheral artery disease testing cenvacibart and amrecibart, two Factor XI antibodies, individually against standard of care1.
On regulatory approvals, the FDA and European Commission approved Dupixent in April 2026 for chronic spontaneous urticaria in children aged 2 to 11 who remain symptomatic despite antihistamines1, and the FDA approved extended EYLEA HD dosing intervals up to every 20 weeks for wet AMD and diabetic macular edema patients after one year of successful response1.
On cash position, Regeneron repurchased $1.2 billion of common stock in the quarter and $2.0 billion over the first six months of 2026, with $2.5 billion remaining available under its repurchase programs as of June 30, 20261. The company also fully repaid the Sanofi Development Balance by the end of the second quarter, which it said would drive a step-up in collaboration profits beginning in the third quarter.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.