---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-277506"
form_type: "8-K"
ticker: "SPRO"
cik: "0001701108"
company_name: "Spero Therapeutics, Inc."
filed_at: "2026-06-22T20:05:06+00:00"
generated_at: "2026-06-22T20:11:14.325933+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Spero Therapeutics' Utebzi, first oral carbapenem for cUTIs

## Summary
- Utebzi (tebipenem pivoxil) approved June 17, 2026 for complicated UTIs in adults with limited oral alternatives.
- PIVOT-PO trial showed 58.5% overall success vs 60.2% for IV imipenem-cilastatin (adjusted diff -1.3%).
- Most common AEs were diarrhea and headache; all mild/moderate and non-serious.
- GSK holds exclusive global license (excl. select Asia); BARDA supported development.
- Product anticipated to be available in US by end of 2026.

## SEC filing metadata
- accession: 0001193125-26-277506
- form_type: 8-K
- ticker: SPRO
- cik: 0001701108
- company_name: Spero Therapeutics, Inc.
- filed_at: 2026-06-22T20:05:06+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701108/000119312526277506/0001193125-26-277506-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701108/000119312526277506/d51395d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-277506
- JSON: https://secwatch.observer/filing/0001193125-26-277506.json
- Plain text: https://secwatch.observer/filing/0001193125-26-277506.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.