Acurx Pharma Reports Positive FDA Meeting for Ibuzatrelvir Phase 3 Program

Acurx Pharmaceuticals (NASDAQ: ACXP) has announced a successful Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 clinical development program for ibezapolstat, its novel antibiotic candidate for the treatment of Clostridioides difficile infection (CDI). The FDA indicated it is open to discussing the potential for a New Drug Application (NDA) based on a single successful Phase 3 trial, depending on the totality of the clinical and supportive data available at the time of submission.

The agency also acknowledged Acurx’s planned clinical trial in recurrent CDI, noting that positive results could support an NDA submission. If the study does not meet the required criteria, the FDA recommends conducting a second Phase 3 trial consistent with prior end-of-Phase 2 guidance. The regulatory feedback marks an important milestone as Acurx advances its late-stage antibiotic development program.

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