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SPRO FDA decision: Jun 17, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

Spero Therapeutics Inc., Utebzi (Tebipenem HBr) - (PIVOT-PO) · Complicated urinary tract infection (cUTI), includ.

Run-up into the decision (T-120 → T+5)

PDUFA 6/17/26$2.98$2.1412/31/25
Daily close, T-120 (12/31/25) through T+5. Run-up high $2.98 on 6/4/26, low $2.14 on 2/6/26 (T-120 to T-1). FDA decision 6/17/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-17
OutcomeApproved
Drug / candidateUtebzi (Tebipenem HBr) - (PIVOT-PO)
CompanySpero Therapeutics Inc.
120-day run-up (T-120→T-1)+18.9%

Questions

Was Utebzi (Tebipenem HBr) - (PIVOT-PO) approved by the FDA?

Yes. The FDA approved the application for Utebzi (Tebipenem HBr) - (PIVOT-PO) on June 17, 2026. The primary source is linked on this page.

Which company is behind Utebzi (Tebipenem HBr) - (PIVOT-PO)?

Utebzi (Tebipenem HBr) - (PIVOT-PO) is a Spero Therapeutics Inc. (SPRO) program. The FDA decision came on June 17, 2026; the company's own announcement is linked on this page.

How did SPRO stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), SPRO moved +18.9%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.