ACXP

The proposed proprietary name, or brand name, CIFBEZY has received conditional acceptance from the FDA and also federal trademark allowance from the USPTO These initial milestones will form the basis for the commercial identity of Acurx's lead product candidate, ibezapolstat, as the Company prepares to advance it toward its international Phase 3 registration program for both the acute treatment and reduction of recurrence in C. difficile Infection (CDI) As required, a request for final FDA review and approval of the brand name will be submitted at time of marketing application for the NDA STATEN ISLAND, N.Y.

STATEN ISLAND, N.Y., Aug. 14, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("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, 2026.

STATEN ISLAND, N.Y., Aug. 12, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult‑to‑treat bacterial infections, today announced that the Japan Patent Office and the Mexico Patent Office, respectively, have each granted a new patent which covers Acurx's DNA Polymerase IIIC inhibitors including compositions‑of‑matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to the Company's expanding series of granted patents in the U.S. and abroad.

This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx This prior work included high-resolution elucidation of the interaction of ibezapolstat with its molecular target, DNA polymerase IIIC (pol IIIC, also known as PolC), with mechanistic findings that explain its properties of lacking cross-resistance with other antibiotics and not fostering the emergence of vancomycin-resistant Enterococcus strains, a unique differentiation among anti-CDI antibiotics The new research partnership aims to generate the first-ever 3D structure of PolC from methicillin-resistant Staphylococcus aureus (MRSA) in complex with DNA and an Acurx inhibitor to advance discovery of new antibiotics to treat infections caused by this high-priority pathogen This partnership will extend mechanistic research into PolC inhibition to accelerate the development of novel agents for the systemic treatment of infections caused by a range of Gram-positive pathogens resistant to currently available antibiotics STATEN ISLAND, N.Y., Aug. 10, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced a new scientific partnership with Leiden University Medical Center (LUMC) in the Netherlands.

Acurx has received FDA guidance in meeting minutes from a July 13, 2026 Type C Meeting to discuss ibezapolstat's (IBZ) Phase 3 clinical program, including the potential to submit an NDA (New Drug Application) based on a single Phase 3 trial and a clinical trial design intended to support indications for both treatment and reduction of recurrence of Clostridioides difficile infection (CDI) FDA stated that it is open to further discussion on the totality of evidence from the clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial and any other clinical trials conducted prior to the pre-NDA meeting, particularly if the clinical efficacy results are robust Additionally, the Agency agreed that a successful clinical outcome from a single IBZ-ASPIRE Phase 3 trial, supported by the open-label IBZ-PATHFINDER Phase 2 trial in multiply-recurrent CDI (rCDI) will allow NDA filing for both the acute treatment and the reduction of recurrence of CDI Trial start-up activities for the IBZ-PATHFINDER ground-breaking clinical trial in patients with rCDI have been initiated with patient enrollment to begin in the next few months Acurx is well positioned to commence its international Ph3 IBZ-ASPIRE trial, subject to funding availability Acurx 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., Aug. 3, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced the successful outcome of a Type C Meeting conducted with FDA on July 13, 2026 to discuss ibezapolstat's Phase 3 clinical program and scope of its planned NDA.

Data demonstrated beneficial bacterial taxa persist in fecal samples from patients with rCDI despite multiple prior CDI treatments with the antibiotic standards of care, vancomycin (VAN) and/or fidaxomicin (FDX) Following acute treatment with ibezapolstat (IBZ), these beneficial microorganisms will have the opportunity to repopulate the microbiome in a beneficial way that may prevent recurrence IBZ and FDX were superior in biofilm experimental models with IBZ significantly more effective at killing C. difficile than VAN and FDX Trial start-up activities for a ground-breaking clinical trial in patients with multiply-recurrent CDI (rCDI) have been initiated with the first patient expected to enroll in the next quarter; a successful trial outcome has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence its international Phase 3 registration program in the broader CDI patient population ("acute CDI") Acurx 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.

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STATEN ISLAND, N.Y., July 8, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its second quarter 2026 financial results on Friday, August 14, 2026 at 8:00 am ET before the U.S. financial markets open.

Results are from Acurx's ongoing scientific collaboration with Leiden University Medical Center (LUMC) partially under a grant from Health Holland to further study the mechanism of action of DNA pol IIIC inhibitors LUMC highlighted Acurx's new class of promising antimicrobials, ibezapolstat and related analogues specifically target Gram-positive bacteria High-resolution cryo-electron microscopy resolved the structure of ibezapolstat in relationship to the binding pocket of a Gram-positive DNA pol IIIC to the level of 3.2Å The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), with a development program for post-exposure prophylaxis of inhalation anthrax being planned in parallel Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designations and has received SME (Small and Medium-sized Enterprise) designation by the EMA STATEN ISLAND, N.Y., June 16, 2026 /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.

Acurx Pharmaceuticals (ACXP) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).