Acurx Pharmaceuticals, Inc. (ACXP), Tuesday announced receipt of a favorable opinion from the Paediatric Committee or PDCO of the European Medicines Agency on its Pediatric Investigation Plan for ibezapolstat use in children with C. difficile infection.
This comes as the 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.
In light of this incident, Acurx will proceed with its integrated PIP submission to the FDA.
The company is now set to begin international Phase 3 clinical trials.
Currently, ACXP is trading at $4.13, down 2.75 percent on the Nasdaq.
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