Welcome to our dedicated page for Acurx Pharmaceuticals news (Ticker: ACXP), a resource for investors and traders seeking the latest updates and insights on Acurx Pharmaceuticals stock.
Acurx Pharmaceuticals, Inc. develops small-molecule antibiotics for difficult-to-treat bacterial infections through a Gram-positive selective spectrum approach targeting DNA polymerase IIIC. Its pipeline includes ibezapolstat for Clostridioides difficile infection and additional DNA pol IIIC inhibitor candidates directed at Gram-positive pathogens such as MRSA, VRE, drug-resistant Streptococcus pneumoniae and B. anthracis.
Recurring ACXP news covers antibiotic development updates, microbiome data, scientific conference presentations, intellectual property for DNA pol IIIC inhibitors, financial results, registered offerings, warrant activity and investor-presentation announcements.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported that the FDA has conditionally accepted CIFBEZY as the proposed proprietary brand name for its lead antibiotic candidate ibezapolstat, for acute treatment and reduction of recurrence of C. difficile infection (CDI). The USPTO has also allowed the CIFBEZY trademark, providing regulatory and intellectual-property milestones for future commercialization.
Commercial use of CIFBEZY remains contingent on U.S. NDA approval, with final FDA name review to occur at marketing application. Ibezapolstat is Phase 3–ready, with FDA guidance indicating a single Phase 3 IBZ-ASPIRE trial, supported by the IBZ-PATHFINDER Phase 2 rCDI trial, may support an NDA for both treatment and recurrence reduction.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported second quarter 2026 results and a business update for the period ended June 30, 2026. Cash totaled $10.7 million, up from $7.6 million at December 31, 2025, supported by a $2.5 million registered direct offering, $0.8 million raised under an equity line, and new short‑term warrants for 1,650,170 shares.
Q2 research and development expenses were $1.1 million versus $0.5 million a year earlier, while general and administrative expenses fell to $1.2 million from $1.7 million. Net loss was $2.3 million ($0.53/share), versus $2.2 million ($1.89/share) in Q2 2025. Operationally, the company advanced ibezapolstat toward Phase 3 in C. difficile infection, received FDA conditional proprietary name acceptance, extended its DNA pol IIIC research partnership with Leiden University Medical Center, presented new microbiome and biofilm data, and obtained additional patents in Japan and Mexico, bringing its portfolio to six U.S. and ten international patents.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced that the Japan Patent Office and the Mexico Patent Office have each granted new patents covering its DNA Polymerase IIIC inhibitor antibiotics. The patents include compositions of matter, methods of use, and pharmaceutical compositions, expanding protection for ibezapolstat and the ACX‑375C program.
According to Acurx, this brings its total to six U.S. patents and ten international patents across Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all focused on DNA Polymerase IIIC–targeting programs. The company notes that additional country-level patent applications remain under review, and management highlights these patents as strengthening its intellectual property estate supporting ibezapolstat and its AI-supported drug discovery platform for difficult-to-treat bacterial infections.
Acurx Pharmaceuticals (Nasdaq: ACXP) announced a new scientific partnership with Leiden University Medical Center (LUMC) to advance its DNA polymerase IIIC (PolC) inhibitor antibiotics. The collaboration builds on a November 2025 Health-Holland grant project that produced detailed 3D structures of Enterococcus PolC-inhibitor complexes published in Nature Communications.
The new work aims to generate the first-ever 3D structure of PolC from MRSA bound to DNA and an Acurx inhibitor, to guide design of systemic antibiotics against resistant Gram-positive pathogens. Acurx highlighted ibezapolstat, its Phase 3–ready CDI candidate, recent FDA Type C guidance supporting a potential NDA based on a single Phase 3 trial, and ongoing startup of the IBZ-PATHFINDER Phase 3 trial in recurrent CDI. The company also outlined preclinical PolC inhibitor programs targeting MRSA-related infections and inhalational anthrax.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported that following a July 13, 2026 FDA Type C Meeting, the Agency indicated it is open to considering a single Phase 3 trial (IBZ-ASPIRE) plus supportive data as the basis for an NDA for ibezapolstat in Clostridioides difficile infection (CDI), depending on the overall strength, consistency, and safety of the clinical results.
The FDA agreed that the planned ~550-patient, non-inferiority IBZ-ASPIRE trial, comparing ibezapolstat with vancomycin, could, if successful, support indications for both acute treatment and reduction of recurrence of CDI. FDA also stated that positive data from the open-label IBZ-PATHFINDER Phase 2 rCDI trial would support the NDA. If single-trial criteria are not met, FDA recommends a second Phase 3 study per the earlier EOP2 agreement. Acurx has initiated start-up for IBZ-PATHFINDER and is positioned to begin the international IBZ-ASPIRE trial, subject to funding, and continues to benefit from FDA QIDP and Fast-Track designations and EMA SME status.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported new microbiome and in vitro data on its antibiotic ibezapolstat in multiply‑recurrent Clostridioides difficile infection (rCDI), presented at the 18th Biennial Congress of the Anaerobe Society of the Americas.
According to Acurx and University of Houston researchers, beneficial gut bacteria involved in bile acid metabolism persist in patients with ≥2 CDI recurrences despite multiple prior vancomycin and/or fidaxomicin courses, and may regrow after ibezapolstat, which showed microbiome selectivity in earlier trials. Laboratory studies indicated ibezapolstat effectively killed C. difficile in planktonic and biofilm co‑culture with Enterococcus, outperforming fidaxomicin in biofilm killing and avoiding vancomycin‑associated VRE overgrowth. Acurx has initiated start‑up activities for a 20‑patient open‑label rCDI pilot trial and plans an active‑controlled Phase 3 rCDI registration trial, alongside an international Phase 3 program in acute CDI, supported by consistent FDA and EMA feedback and existing FDA QIDP/Fast Track and EMA SME designations.
Acurx Pharmaceuticals (NASDAQ: ACXP) will host a conference call on Friday, August 14, 2026, at 8:00 a.m. ET to discuss its second quarter 2026 financial results and provide a business update.
The call will be led by President and CEO David P. Luci and CFO Robert G. Shawah.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported new structural biology results from its public‑private partnership with Leiden University Medical Center on DNA pol IIIC inhibitors, including lead candidate ibezapolstat.
High‑resolution cryo‑EM mapped ibezapolstat bound to Gram‑positive DNA pol IIIC at 3.2Å, supporting broad Gram‑positive targeting and informing Acurx’s preclinical pipeline for CDI, ABSSSI and inhalation anthrax.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported Q1 2026 results and business updates. Cash was $9.3M vs. $7.6M at year-end 2025, after raising about $3.1M via its equity line. Net loss narrowed to $1.7M ($0.62/share) from $2.1M.
The company advanced ibezapolstat for C. difficile, initiating a Phase 2 rCDI trial and preparing Phase 3 acute CDI studies, while expanding its global DNA pol IIIC patent estate with new U.S. and Korean grants.
Acurx (NASDAQ: ACXP) presented preclinical data at ESCMID Global 2026 showing that its DNA pol IIIC inhibitor candidates achieved systemic antibacterial activity against MRSA in neutropenic mice while preserving gut microbiome diversity compared with linezolid. The compounds reached potentially therapeutic plasma levels and maintained a Bacteroidota-dominant community, preventing Proteobacteria expansion.
Data suggest a class effect for microbiome-sparing Gram-positive antibiotics and note FDA QIDP and Fast-Track eligibility for Acurx preclinical candidates.