Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
VYVGART was approved by the FDA for myasthenia Gravis; the approval was announced on May 8, 2026.
argenx SE, VYVGART · Myasthenia Gravis.
Run-up into the decision (T-120 → T+5)
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.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was VYVGART approved by the FDA?
Yes. The approval of the application for VYVGART was announced on May 8, 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 VYVGART?
VYVGART is an argenx SE (ARGX) program. The company announced the FDA decision on May 8, 2026; the primary source 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.
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