pdufa.bio
HomeDecisions › ARGX 2026-05-08

ARGX FDA decision — May 8, 2026

✓ 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%