Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
DUPIXENT (dupilumab) was approved by the FDA on April 22, 2026.
Sanofi, DUPIXENT (dupilumab).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (11/5/25) through T+5. Run-up high $52.34 on 11/21/25, low $43.6 on 3/16/26 (T-120 to T-1). FDA decision 4/22/26. Historical price action, not a forecast.
Drug / candidateDUPIXENT (dupilumab) - (LIBERTY-CUPID)
CompanySanofi
120-day run-up (T-120→T-1)-7.7%
FDA record of the action: the FDA approved on April 22, 2026, per BLA 761055 SUPPL-74 (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 DUPIXENT (dupilumab) approved by the FDA?
Yes. The FDA approved the application for DUPIXENT (dupilumab) on April 22, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind DUPIXENT (dupilumab)?
DUPIXENT (dupilumab) is a Sanofi (SNY) program. The FDA decision came on April 22, 2026; the FDA's own record of the decision is linked on this page.
How did SNY stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), SNY moved -7.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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