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.
Protagonist Therapeutics Inc., ICOTYDE (icotrokinra) · Plaque psoriasis.
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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| RTW Investments | 5,061,175 | $620.4 million | filed August 14, 2026 |
| Perceptive Advisors | 981,879 | $120.4 million | filed August 14, 2026 |
| OrbiMed Advisors | 42,100 | $5.2 million | filed August 14, 2026 |
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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.
ICOTYDE (icotrokinra) is a Protagonist Therapeutics Inc. (PTGX) program. The FDA decision came on March 17, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), PTGX moved +47.4%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.