---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-238439"
form_type: "8-K"
ticker: "SPRO"
cik: "0001701108"
company_name: "Spero Therapeutics, Inc."
filed_at: "2022-09-06T23:59:59+00:00"
generated_at: "2026-06-23T15:31:07.557397+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Spero Therapeutics: FDA agrees single additional Phase 3 trial could support approval of tebipenem HBr for cUTI

## Summary
- FDA indicated positive results from one additional Phase 3 trial, plus confirmatory nonclinical evidence, could support approval.
- Spero plans to advance tebipenem HBr development and potential commercialization through external partnership.
- Type A meeting follows June 2022 CRL; FDA aligned on key components for pivotal trial design, with possible SPA.
- If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the U.S.

## SEC filing metadata
- accession: 0001193125-22-238439
- form_type: 8-K
- ticker: SPRO
- cik: 0001701108
- company_name: Spero Therapeutics, Inc.
- filed_at: 2022-09-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701108/000119312522238439/0001193125-22-238439-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701108/000119312522238439/d331031d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-238439
- JSON: https://secwatch.observer/filing/0001193125-22-238439.json
- Plain text: https://secwatch.observer/filing/0001193125-22-238439.txt

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