Acurx Announces Successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for Ibezapolstat in the Treatment of C. difficile Infection
ACXPAcurx Pharmaceuticals(ACXP) Prnewswire·2024-05-15 21:00

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 allow ...