Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
ICOTYDE (icotrokinra) was approved by the FDA on March 17, 2026 to treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy, the 7th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Johnson & Johnson, ICOTYDE (icotrokinra) · Plaque psoriasis.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (10/1/25) through T+5. Run-up high $248.56 on 3/2/26, low $176.69 on 10/1/25 (T-120 to T-1). FDA decision 3/18/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-03-18
OutcomeApproved
Drug / candidateICOTYDE (icotrokinra)
CompanyJohnson & Johnson
120-day run-up (T-120→T-1)+34.8%
FDA record of the action: the FDA approved on March 17, 2026, per NDA 220149 ORIG-1 (FDA letter). The sponsor announced it on March 18, 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 ICOTYDE (icotrokinra) approved by the FDA?
Yes. The FDA approved the application for ICOTYDE (icotrokinra) on March 17, 2026, per the FDA's own record. The company announced it on March 18, 2026. The primary source is linked on this page.
Which company is behind ICOTYDE (icotrokinra)?
ICOTYDE (icotrokinra) is a Johnson & Johnson (JNJ) program. The FDA decision came on March 17, 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 +34.8%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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