Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Linerixibat was approved by the FDA on March 17, 2026 to treat cholestatic pruritus associated with primary biliary cholangitis, the 6th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Daily close, T-120 (10/2/25) through T+5. Run-up high $61.18 on 2/18/26, low $39.52 on 10/2/25 (T-120 to T-1). FDA decision 3/19/26. Historical price action, not a forecast.
FDA record of the action: the FDA approved on March 17, 2026, per NDA 220295 ORIG-1 (FDA letter). The sponsor announced it on March 19, 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 Linerixibat approved by the FDA?
Yes. The FDA approved the application for Linerixibat on March 17, 2026, per the FDA's own record. The company announced it on March 19, 2026. The primary source is linked on this page.
Which company is behind Linerixibat?
Linerixibat is a GSK plc (GSK) program. The FDA decision came on March 17, 2026; the FDA's own record of the decision is linked on this page.
How did GSK stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), GSK moved +31.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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