Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Arexvy was approved by the FDA; the approval was announced on March 13, 2026.
GSK plc, Arexvy.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (9/26/25) through T+5. Run-up high $61.18 on 2/18/26, low $39.52 on 10/2/25 (T-120 to T-1). FDA decision 3/13/26. Historical price action, not a forecast.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Arexvy approved by the FDA?
Yes. The approval of the application for Arexvy was announced on March 13, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Which company is behind Arexvy?
Arexvy is a GSK plc (GSK) program. The company announced the FDA decision on March 13, 2026; the primary source is linked on this page.
How did GSK stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), GSK moved +33.5%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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