Acurx Pharma Receives Favorable Opinion From PDCO Of EMA On Acurx's Pediatric Investigation Plan For Ibezapolstat Use In Children With C. Difficile Infection

Author: Benzinga Newsdesk | September 30, 2025 07:34am

• The Paediatric Committee (PDCO) of the European Medicines Agency issued a positive opinion on Acurx's Pediatric Investigation Plan (PIP) for ibezapolstat use in children with C. difficile infection
• Receipt of this positive opinion caps off the EMA's requirement to have the PIP agreed to by the initiation of ibezapolstat Phase 3 clinical trials in the European Union
• Acurx previously announced that both the EMA and the FDA are aligned with its clinical trial program in the adult population along with clearly defined requirements for the regulatory pathway to an EU MAA and a U.S. NDA
• In addition to receiving this positive EMA opinion, Acurx will proceed with its integrated PIP submission to the FDA
• Acurx is well positioned to begin international Phase 3 clinical trials and has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA

STATEN ISLAND, N.Y., Sept. 30, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections announced receipt of a favorable opinion from the PDCO of the EMA on Acurx's Pediatric Investigation Plan (PIP) for ibezapolstat use in children with C. difficile infection (CDI).

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