Acurx Pharmaceuticals Inc Stock Price, News & Analysis

Acurx Pharmaceuticals (NASDAQ: ACXP) announced positive results from an in-silico study of ibezapolstat (IBZ), its lead antibiotic candidate for C. difficile Infection (CDI) treatment. The study, published in the Journal of Antimicrobial Agents and Chemotherapeutics, explains IBZ's selective antimicrobial activity.

The research revealed that IBZ's bactericidal interaction with its target DNA pol IIIC is conserved across most Bacillota phylum, including C. difficile, while beneficial gut bacteria remain naturally resistant. This mechanism explains the narrower spectrum of activity observed in human trials, where IBZ allowed the regrowth of beneficial microbiota.

The study, funded by the National Institute of Allergy and Infectious Diseases, demonstrates IBZ's advantage over vancomycin, which kills beneficial microbes and leads to higher C. difficile recurrence rates. IBZ is preparing to advance to international Phase 3 clinical trials and has received FDA QIDP, Fast-Track, and EMA SME designations.

Acurx Pharmaceuticals (NASDAQ: ACXP) has been granted a new patent by the Japanese Patent Office in January 2025 for DNA Polymerase IIIC Inhibitors, covering compositions-of-matter, surface coatings, and pharmaceutical compositions for treating Gram-positive bacterial infections. This adds to their existing portfolio of three U.S. patents, one Israeli patent, and additional pending applications.

The company has received positive regulatory guidance from the EMA for its Phase 3-ready ibezapolstat program, designed to treat and prevent recurrence of C. difficile Infection. The EMA's Scientific Advice Procedure confirmed that Acurx's clinical, non-clinical, and CMC package supports advancement to Phase 3 trials and potential MAA submission in Europe.

The planned Phase 3 program consists of two international trials comparing ibezapolstat to vancomycin, with 450 subjects in the Modified Intent-To-Treat population for the initial trial. The study will evaluate both Clinical Cure of CDI and potential reduction in recurrence rates.

Acurx Pharmaceuticals (NASDAQ: ACXP) has completed its previously announced registered direct offering, raising $2.5 million through the sale of 2,463,058 common stock shares at $1.015 per share, priced at-the-market under Nasdaq rules. The company also issued unregistered warrants in a concurrent private placement to purchase up to 2,463,058 shares at an exercise price of $0.90 per share, exercisable immediately and expiring in five years.

H.C. Wainwright & Co. served as the exclusive placement agent. The net proceeds, after deducting placement agent fees and offering expenses, will be used for working capital and general corporate purposes. The common stock shares were offered through a shelf registration statement, while the warrants were issued through a private placement under Section 4(a)(2) of the Securities Act.

Acurx Pharmaceuticals (NASDAQ: ACXP) has announced a $2.5 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 2,463,058 shares of common stock at $1.015 per share. Additionally, in a concurrent private placement, ACXP will issue unregistered warrants to purchase up to 2,463,058 shares with an exercise price of $0.90 per share, exercisable upon issuance and expiring in five years.

The offering, expected to close around January 7, 2025, is being conducted with H.C. Wainwright & Co. as the exclusive placement agent. The net proceeds will be used for working capital and general corporate purposes. The common stock shares are being offered through a shelf registration statement, while the warrants are being issued in a private placement under Section 4(a)(2) of the Securities Act.

Acurx Pharmaceuticals (NASDAQ: ACXP) has received positive regulatory guidance from the European Medicines Agency (EMA) for its ibezapolstat Phase 3 program targeting C. difficile Infection (CDI). The EMA's Scientific Advice Procedure confirmed that the clinical, non-clinical, and CMC information package supports advancing to Phase 3 trials.

The company plans two Phase 3 non-inferiority pivotal trials versus vancomycin, with an estimated 450 subjects in the Modified Intent-To-Treat population randomized 1:1. The primary endpoint will measure Clinical Cure of CDI after 10 days of oral treatment, with additional assessment of CDI recurrence reduction. If non-inferiority is demonstrated, superiority testing will follow.

Ibezapolstat has already received FDA QIDP and Fast-Track Designation, and Acurx holds EMA SME designation. The company is preparing to request regulatory guidance for clinical trials in Japan, Canada, and the United Kingdom.

Acurx Pharmaceuticals (NASDAQ:ACXP), a late-stage biopharmaceutical company focused on developing novel small molecule antibiotics, has announced its participation in The Microcap Conference. The event will be held from January 28-30, 2025, at the Borgata Hotel in Atlantic City, New Jersey. David P. Luci, President & CEO, will deliver the company's presentation on Wednesday, January 29, 2025, at 10 am ET. The company specializes in developing treatments for difficult-to-treat bacterial infections.

Acurx Pharmaceuticals has provided updates on the Phase 3 readiness of its lead antibiotic candidate, ibezapolstat, for treating C. difficile Infection (CDI). The FDA has given positive feedback on the proposed Chemistry Manufacturing and Controls (CMC) plan, and Acurx is awaiting final advice from the European Medicines Agency (EMA) for the Phase 3 clinical program in the EU. The company is also discussing pediatric development plans with both the FDA and EU authorities. Acurx is preparing to request regulatory guidance for initiating clinical trials in Japan, Canada, and the UK.

Phase 3 international trial planning is advancing, utilizing AI to identify optimal clinical trial sites. Ibezapolstat has previously received FDA QIDP and Fast-Track Designation and SME designation from the EMA. The Phase 3 trial will involve approximately 450 subjects, comparing ibezapolstat to vancomycin, with a focus on achieving clinical cure and reducing CDI recurrence. The Executive Chairman expressed confidence in the trial's success, which would pave the way for US NDA submission and EU Marketing Authorization.

Acurx Pharmaceuticals (NASDAQ: ACXP) announced that its Board of Directors has approved the purchase of up to $1 million in Bitcoin as a treasury reserve asset. The company views this as a strategic move for cash not needed in the next 12-18 months, citing Bitcoin's growing demand, acceptance as a major asset class, and inflation-resistant characteristics. The company emphasized that this financial strategy will not affect their core drug development plans.

Acurx Pharmaceuticals (NASDAQ: ACXP) participated in the Peggy Lillis Foundation's Inaugural CDI Scientific Symposium, presenting updated Phase 2b clinical data for ibezapolstat. The company is preparing to advance its lead antibiotic candidate into international Phase 3 clinical trials for C. difficile Infection (CDI) treatment. Dr. Kevin Garey presented microbiome results showing ibezapolstat promotes beneficial bacteria growth while avoiding harmful Proteobacteria overgrowth. The FDA has agreed on key elements for two Phase 3 pivotal trials, requiring approximately 450 subjects in the Modified Intent-To-Treat population, randomized 1:1 between ibezapolstat and vancomycin.