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REGN FDA decision: Apr 2, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

EYLEA HD (aflibercept) was approved by the FDA on April 2, 2026 for diabetic macular edema (DME).

Regeneron Pharmaceuticals Inc., EYLEA HD (aflibercept) · 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%

FDA record of the action: the FDA approved on April 2, 2026, per BLA 761355 SUPPL-5 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.

Questions

Was EYLEA HD (aflibercept) approved by the FDA?

Yes. The FDA approved the application for EYLEA HD (aflibercept) on April 2, 2026, per the FDA's own record. The primary source is linked on this page.

Which company is behind EYLEA HD (aflibercept)?

EYLEA HD (aflibercept) is a Regeneron Pharmaceuticals Inc. (REGN) program. The FDA decision came on April 2, 2026; the FDA's own record of the decision is linked on this page.

How did REGN stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), REGN moved +36.4%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.