Acurx Reports Outcome Of FDA End-of-Phase 2 Meeting And Phase 3 Readiness For Ibezapolstat For Treatment Of C. difficile Infection
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Biotechnology: Pharmaceutical Preparations
Health Care
- Agreement with FDA reached on key elements to move forward with our international Phase 3 clinical trial program
- Agreement also reached with FDA on complete non-clinical and clinical development plan for filing of a New Drug Application for marketing approval
- Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)
- SME (Small and Medium-sized Enterprise) designation has been granted by the EMA (European Medicines Agency), which allows Acurx to benefit from fee incentives and other support from the EMA for EU Marketing Authorization
- Acurx is now preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada
- Ibezapolstat has previously received FDA QIDP and Fast-Track Designation from FDA