Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Tebipenem HBr (SPR994) was approved by the FDA on June 17, 2026 for complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), the 22nd novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
GSK plc, Utebzi (Tebipenem HBr).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (12/31/25) through T+5. Run-up high $61.18 on 2/20/26, low $47.65 on 1/23/26 (T-120 to T-1). FDA decision 6/17/26. Historical price action, not a forecast.
Drug / candidateUtebzi (Tebipenem HBr) - (PIVOT-PO)
CompanyGSK plc American Depositary Shares (Each
120-day run-up (T-120→T-1)+6.9%
FDA record of the action: the FDA approved on June 17, 2026, per NDA 215960 ORIG-1 (FDA letter). The sponsor announced it the same day. 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 Utebzi (Tebipenem HBr) approved by the FDA?
Yes. The FDA approved the application for Utebzi (Tebipenem HBr) on June 17, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Utebzi (Tebipenem HBr)?
Utebzi (Tebipenem HBr) is a GSK plc (GSK) program. The FDA decision came on June 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 +6.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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