other material
confidence high
sentiment positive
materiality 0.85
Citius Pharma: Mino-Lok Phase 3 trial meets primary endpoint (p=0.0006) in CLABSI/CRBSI
Citius Pharmaceuticals, Inc.
- Primary endpoint: time to catheter failure significantly delayed for Mino-Lok vs control (p=0.0006); hazard ratio 0.53.
- Median time-to-failure for control arm: 33 days; Mino-Lok arm median not reached (NE; CI 50 days-NE).
- Secondary endpoint overall success: 57.1% Mino-Lok vs 37.7% control (p=0.0025).
- No drug-related serious adverse events reported; safety profile supports well-tolerated designation.
- Company plans to engage with FDA to determine next regulatory steps for Mino-Lok.