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0 0.0147857142857143 0.0214285714285714 0.0214285714285714 0 -0.00238095238095233 -0.0309523809523809 0
Stock impact report

Acurx Announces Positive Opinion from EMA on Pediatric Investigation Plan for Ibezapolstat Use in Children with C. difficile Infection [Yahoo! Finance]

Acurx Pharmaceuticals, Inc. (ACXP) 
Company Research Source: Yahoo! Finance
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 ann Show less Read more
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