pdufa.bio
HomeDecisions › REGN 2026-04-02

REGN FDA decision — Apr 2, 2026

✓ APPROVED

Regeneron Pharmaceuticals Inc. — EYLEA HD (aflibercept) - (PHOTON ext) · Diabetic macular edema (DME).

Run-up into the decision (T-120 → T+5)

PDUFA 4/2/26$812.27$557.7310/16/25
Daily close, T-120 (10/16/25) through T+5. Run-up high $812.27 on 1/9/26, low $557.73 on 10/20/25 (T-120 to T-1). FDA decision 4/2/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-02
OutcomeApproved
Drug / candidateEYLEA HD (aflibercept) - (PHOTON ext)
CompanyRegeneron Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+36.4%