Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
TREMFYA (guselkumab) was approved by the FDA on May 28, 2026 for active psoriatic arthritis.
Johnson & Johnson, TREMFYA (guselkumab) · Active psoriatic arthritis.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (12/12/25) through T+5. Run-up high $248.56 on 3/4/26, low $199.96 on 12/17/25 (T-120 to T-1). FDA decision 5/29/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-05-29
OutcomeApproved
Drug / candidateTREMFYA (guselkumab)
CompanyJohnson & Johnson
120-day run-up (T-120→T-1)+14.0%
FDA record of the action: the FDA approved on May 28, 2026, per BLA 761061 SUPPL-34 (FDA letter). The sponsor announced it on May 29, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was TREMFYA (guselkumab) approved by the FDA?
Yes. The FDA approved the application for TREMFYA (guselkumab) on May 28, 2026, per the FDA's own record. The company announced it on May 29, 2026. The primary source is linked on this page.
Which company is behind TREMFYA (guselkumab)?
TREMFYA (guselkumab) is a Johnson & Johnson (JNJ) program. The FDA decision came on May 28, 2026; the FDA's own record of the decision is linked on this page.
How did JNJ stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), JNJ moved +14.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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