Acurx Pharmaceuticals Receives Positive EMA Opinion on Pediatric Investigation Plan for Ibezapolstat in Children with C. difficile Infection, Advancing Toward Phase 3 Trials

**Acurx Pharmaceuticals Receives Positive EMA Opinion for Pediatric Study of Ibezapolstat** Acurx Pharmaceuticals Inc. $(ACXP)$ announced it has received a positive opinion from the Paediatric Committee $(PDCO)$ of the European Medicines Agency $(EMA)$ regarding its Pediatric Investigation Plan $(PIP)$ for ibezapolstat, a novel antibiotic for treating Clostridioides difficile infection (CDI) in children. This regulatory milestone fulfills a key EMA requirement ahead of the planned Phase 3 clinical trials in Europe. The company, which has also been granted FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation, will now proceed with a similar PIP submission to the U.S. FDA. No grant or funding from multiple organizations was announced-this update pertains solely to Acurx's regulatory progress. If successful, ibezapolstat could receive an additional year of marketing exclusivity in Europe on top of the standard 10-year exclusivity for new antibiotics.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Acurx Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NY86075) on September 30, 2025, and is solely responsible for the information contained therein.