STATEN ISLAND, N.Y., Oct. 26, 2026 /PRNewswire/ — Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), a late-stage biopharmaceutical company developing a new class of antibiotics for serious and life threatening bacterial infections, announced today that the Company will discuss its third quarter 2026 financial results on Thursday, November 12, 2026 at 8:00 am ET before the U.S. financial markets open.
David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:
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Date: |
Thursday, November 12, 2026 |
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Time: |
8:00 a.m. ET |
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Toll free (U.S.): |
877-790-1503 Access ID: 13763499 |
Click here for participant International Toll-Free access numbers
About Ibezapolstat
Ibezapolstat is the Company’s lead antibiotic candidate targeting patients with C. difficile infection. The Company has initiated enrollment of a ground-breaking clinical trial in patients with multiply-recurrent CDI (rCDI) with the first patient enrolled in September 2026. This open-label, single arm 20-patient, pilot trial will enroll patients with multiply-recurrent CDI with at least 3 prior episodes of CDI within the past 12 months. If successful, the Company plans to target a Phase 3 regulatory strategy with just one Phase 3 registration trial in rCDI pursuant to FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway), subject to concurrence with FDA, based on the data generated in the open-label trial. Upon subsequent successful completion of a Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI. Successful trial outcome has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one.
In addition, subject to receiving appropriate funding, Acurx is planning to advance to international Phase 3 clinical trials to treat patients with acute C. difficile infection. As previously announced, the Company has received final FDA agreement for our ibezapolstat pivotal Phase 3 trial in acute CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear roadmap for conduct of its Phase 3 program in acute CDI and, if successful, requirements for US NDA submission.
Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat’s unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.
In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted “Fast Track” designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for serious and life threatening bacterial infections. The Company’s approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx’s lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company’s preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for post-exposure prophylaxis of inhalation anthrax is being planned in parallel.
To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.
Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2025 as filed with the Securities and Exchange Commission on March 12 2026 and in the Company’s subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President & CEO
Tel: 917-533-1469
Email: davidluci@acurxpharma.com
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SOURCE Acurx Pharmaceuticals, Inc.
