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News 2026-09-21 11:28 UTC

Acurx says FDA signaled NDA could hinge on totality of data

Acurx Pharmaceuticals (NASDAQ:ACXP) said the FDA signaled an NDA could rest on the totality of data, potentially including a single robust Phase 3, with planned rCDI trial results adding support. The company also cited in vitro co-culture work showing ibezapolstat outperformed vancomycin and fidaxomicin against C. diff