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ARGX FDA decision: May 8, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

argenx SE: VYVGART - (ADAPT SERON) · Myasthenia Gravis.

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

PDUFA 5/8/26$929.61$663.9311/21/25
Daily close, T-120 (11/21/25) through T+5. Run-up high $929.61 on 11/25/25, low $663.93 on 3/23/26 (T-120 to T-1). FDA decision 5/8/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-08
OutcomeApproved
Drug / candidateVYVGART - (ADAPT SERON)
Companyargenx SE
120-day run-up (T-120→T-1)-11.7%

Questions

Was VYVGART - (ADAPT SERON) approved by the FDA?

Yes. The FDA approved the application for VYVGART - (ADAPT SERON) on May 8, 2026. The primary source is linked on this page.

Which company is behind VYVGART - (ADAPT SERON)?

VYVGART - (ADAPT SERON) is a argenx SE (ARGX) program. The FDA decision came on May 8, 2026; the company's own announcement is linked on this page.

How did ARGX stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), ARGX moved -11.7%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.