
EMA Positive Opinion: A major recent catalyst for Acurx came on September 30, 2025, when the EMA’s Paediatric Committee issued a positive opinion on the Pediatric Investigation Plan for Acurx’s lead drug, ibezapolstat, in Clostridioides difficile infectioninvesting.com. This essentially means European regulators agree with Acurx’s plan to study ibezapolstat in children, a prerequisite for future marketing approval in Europe. As the company noted, the PIP approval “ensur[es] necessary data are obtained to support the drug’s authorization and use in pediatric populations.”investing.com This news helped lift ACXP stock from about $4.18 to $4.60 at the end of that weeknasdaq.com, reflecting investor optimism about Acurx’s regulatory momentum.
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