Business
Acurx Pharmaceuticals, Inc. Reports Second Quarter 2024 Results and Provides Business Update
STATEN ISLAND, N.Y., Aug. 9, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"STATEN ISLAND, N.Y., Aug. 9, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (\"we\" or \"Acurx\" or the \"Company\"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the second quarter ended June 30, 2024. \n\nHighlights of the second quarter ended June 30, 2024, or in some cases shortly thereafter, include:\nIn April 2024, we completed a successful End-of-Phase 2 Clinical Meeting with FDA and confirmed Phase 3 Readiness for ibezapolstat (IBZ) to enter Phase 3 clinical trials for the treatment of C. difficile infection. Agreement with FDA was reached on key elements to move forward with our international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. We've since continued activities to advance IBZ into international Phase 3 clinical trials for treatment of C. difficile Infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada.Also in April 2024, we attended the European Society of Microbiology and Infectious Disease (or ESCMID) scientific congress. Dr. Kevin Garey provided an oral presentation of our Phase 2 data entitled: \"A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of C. difficile Infection.\" Dr. Garey is Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for microbiology and microbiome aspects of the IBZ clinical trial program and Acurx Scientific Advisory Board member. The oral presentation included additional analyses of clinical and microbiological data and is available on our website at www.acurxpharma.com. The complete Phase 2 results are being prepared for submission to a prominent scientific journal for publication. The oral presentation is available on our website at www.acurxpharma.com.In May 2024, we announced that the European Medicines Agency (or EMA) approved our application to be designated as a small to medium sized enterprise (or SME) in Europe which provides for certain benefits including fee reduc...