regulatory
confidence high
sentiment negative
materiality 0.85
FDA rejects Spero's tebipenem HBr NDA for cUTI; additional clinical study required
Spero Therapeutics, Inc.
- Received Complete Response Letter on June 27, 2022 for tebipenem HBr oral tablets cUTI NDA.
- FDA determined Phase 3 ADAPT-PO study insufficient; additional clinical study needed.
- Company plans to request a Type A meeting with FDA to discuss path forward.
- CEO expressed disappointment but commitment to pursue regulatory approval and potential partnerships.