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. (NASDAQ: ACXP) is a late-stage biopharmaceutical company specializing in developing innovative antibiotics designed to combat drug-resistant bacterial infections. The company's leading drug candidate, ibezapolstat, is an orally administered antibiotic developed to treat Clostridioides difficile infections (CDI), a serious and life-threatening condition. Acurx is advancing ibezapolstat to Phase 3 clinical trials to establish its efficacy and safety compared to standard treatments such as vancomycin.
Ibezapolstat works by targeting the Gram-Positive Selective Spectrum (GPSS庐) and inhibiting the DNA polymerase IIIC enzyme critical for bacterial replication in Gram-positive bacteria. This mechanism not only effectively treats the infection but also preserves the healthy gut microbiome, thus reducing the likelihood of infection recurrence. Acurx鈥檚 studies have shown promising results, including a 96% clinical cure rate and excellent microbiome preservation, establishing non-inferiority to vancomycin.
The company has received multiple designations from the FDA, including Qualified Infectious Disease Product (QIDP) and Fast Track status, which highlight the urgent need for new antibiotics to treat CDI. These designations facilitate expedited development and review processes, enabling faster patient access to new treatments.
Recent progress includes the successful completion of a Phase 2b clinical trial, which demonstrated high clinical cure rates and no recurrence of infection in patients treated with ibezapolstat. The company has also reached critical milestones with regulatory agencies, including the FDA and EMA (European Medicines Agency), paving the way for international Phase 3 trials.
Acurx is committed to addressing the growing threat of antibiotic resistance. The company鈥檚 R&D pipeline includes additional antibiotics targeting other serious Gram-positive bacterial infections, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and drug-resistant Streptococcus pneumoniae.
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.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported Q3 2024 financial results and business updates. The company ended Q3 with $5.8 million in cash, down from $7.5 million in December 2023. Q3 net loss was $2.8 million ($0.17 per share), compared to $3.1 million ($0.24 per share) in Q3 2023. Key developments include FDA submission for CMC meeting to commence Phase 3 trials, new patent grant for ibezapolstat extending to 2042, and positive Phase 2 trial results presentation showing comparable efficacy to vancomycin. The company raised $1.6 million through ATM financing during the quarter.
Acurx Pharmaceuticals (NASDAQ: ACXP) presented new bile acid and microbiome analyses from their Phase 2b trial of ibezapolstat for C. difficile Infection (CDI) at the IDWeek 2024 Conference. The data showed a favorable gut bile acid profile and restoration of beneficial bacteria in ibezapolstat-treated patients, which may contribute to its anti-recurrence effect. Ibezapolstat demonstrated comparable clinical cure rates and safety to vancomycin, with no recurrence in the 5 patients followed for 3 months post-treatment.
Acurx is preparing to advance ibezapolstat into international Phase 3 clinical trials for CDI treatment, following a successful FDA End-of-Phase 2 Meeting. The company plans to submit requests for regulatory guidance in the EU, UK, Japan, and Canada. Ibezapolstat has previously received FDA QIDP and Fast-Track Designation.
Acurx Pharmaceuticals (NASDAQ: ACXP), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, has announced its participation in the Spartan Capital inaugural investor conference on November 4, 2024, at the Pierre Hotel in New York. The company's CEO, David P. Luci, expressed enthusiasm about the opportunity to showcase Acurx's accomplishments and future plans to key influencers in the capital markets.
The conference, organized in partnership with B2i Digital, will feature presentations from over 30 selected companies, along with panel discussions, one-on-one meetings, and networking sessions. This event aligns with Acurx's commitment to engage with industry leaders and investors, providing a platform to offer insights into the company's growth strategy and market position.
FAQ
What is the current stock price of Acurx Pharmaceuticals (ACXP)?
What is the market cap of Acurx Pharmaceuticals (ACXP)?
What is Acurx Pharmaceuticals' lead drug candidate?
How does ibezapolstat work?
What are the clinical trial results for ibezapolstat?
Has ibezapolstat received any special designations?
What are the next steps for ibezapolstat?
What other infections is Acurx targeting?
What is the significance of ibezapolstat's effect on the microbiome?
What recent regulatory progress has Acurx made?
How does Acurx plan to market ibezapolstat internationally?
Where can I find more information about Acurx Pharmaceuticals?
