Acurx Pharmaceuticals received positive EMA guidance for its ibezapolstat phase 3 programme, supporting advancement with clinical, non-clinical, and CMC data. The phase 3 trials aim to demonstrate non-inferiority to vancomycin, with a focus on Clinical Cure and reducing CDI recurrence. Ibezapolstat, a novel antibiotic, showed a 96% Clinical Cure rate in phase 2 trials, with favorable microbiome changes and secondary bile acid increases suggesting anti-recurrence potential. Acurx plans international phase 3 trials, leveraging FDA's QIDP and Fast Track designations for CDI treatment.