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GSK FDA decision: Mar 13, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

GSK plc American Depositary Shares (Each, Arexvy · Lower respiratory tract disease (LRTD) caused by R.

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

PDUFA 3/13/26$61.18$39.529/26/25
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.

Key facts

FDA decision date2026-03-13
OutcomeApproved
Drug / candidateArexvy
CompanyGSK plc American Depositary Shares (Each
120-day run-up (T-120→T-1)+33.5%

Questions

Was Arexvy approved by the FDA?

Yes. The FDA approved the application for Arexvy on March 13, 2026. The primary source is linked on this page.

Which company is behind Arexvy?

Arexvy is a GSK plc American Depositary Shares (Each (GSK) program. The FDA decision came on March 13, 2026; the company's own announcement 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.