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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®) 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’s 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’s 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.
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Acurx Pharmaceuticals (NASDAQ: ACXP) announced new analyses extending data on ibezapolstat's beneficial effects on the gut microbiome for C. difficile Infection (CDI) treatment. The data showed increased beneficial bacteria, reversing dysbiosis and contributing to CDI anti-recurrence. Ibezapolstat's favorable pharmacokinetics were confirmed with low systemic exposure and high colonic concentrations.
Additionally, certain ACX-375 DNA pol IIIC analogues demonstrated in vitro activity against Anthrax (B. anthracis), including ciprofloxacin-resistant strains. Acurx is planning an Anthrax bioterrorism development program.
The company is preparing to advance ibezapolstat into international Phase 3 clinical trials for CDI treatment and submit requests for regulatory guidance in various countries. Ibezapolstat has previously received FDA QIDP and Fast-Track Designation.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced results from its research on ibezapolstat in collaboration with Leiden University Medical Center (LUMC) at the International C. difficile Symposium. The research revealed high-resolution details of ibezapolstat's interaction with its molecular target, explaining its lack of cross-resistance with other antibiotics and its unique ability to not foster the emergence of Enterococcus, including vancomycin-resistant strains.
Key points:
- Molecular structure data will guide the design of new systemic therapeutic compounds
- Acurx is preparing to advance ibezapolstat into international Phase 3 clinical trials for C. difficile Infection (CDI) treatment
- The company is seeking regulatory guidance to initiate clinical trials in the EU, UK, Japan, and Canada
- Ibezapolstat has received FDA QIDP and Fast-Track Designation
- Agreement reached with FDA on key elements for Phase 3 trials, including protocol design, endpoints, and safety database size
Acurx Pharmaceuticals (Nasdaq: ACXP) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024. The event will be held both in-person at the Lotte New York Palace Hotel in New York City and virtually, featuring over 550 company presentations.
David P. Luci, President & CEO of Acurx Pharmaceuticals, will provide an overview of the company's business during the presentation. Institutional investors can register for the conference through the provided link to access the company presentations and panels, which will be available on-demand starting September 9 at 7:00 A.M. (ET).
Acurx Pharmaceuticals (NASDAQ: ACXP) reported Q2 2024 results and provided a business update. Key highlights include:
- Successful End-of-Phase 2 meeting with FDA, confirming Phase 3 readiness for ibezapolstat (IBZ) in treating C. difficile infection
- Presentation of Phase 2 data at scientific conferences
- EMA approval as SME, providing benefits for European marketing authorization
- New patent granted for IBZ, expiring in June 2042
- Q2 financials: $6.4M cash on hand, R&D expenses of $1.8M, G&A expenses of $2.3M, net loss of $4.1M ($0.26 per share)
- Ongoing preparations for international Phase 3 trials and regulatory submissions in EU, UK, Japan, and Canada
Acurx Pharmaceuticals (NASDAQ: ACXP) has been granted a new patent by the USPTO for ibezapolstat, its treatment for C. difficile Infection (CDI). The patent, issued on July 16, 2024, covers ibezapolstat's ability to treat CDI while reducing infection recurrence and improving gut microbiome health. This patent strengthens Acurx's proprietary technologies in antimicrobials.
The company's Executive Chairman, Robert J. DeLuccia, emphasized the importance of this patent as ibezapolstat continues to show favorable effects on the gut microbiome while curing CDI and preventing recurrent infections. Acurx is preparing for its Phase 3 clinical program, expecting ibezapolstat's selective mechanism of action to provide a competitive advantage over current antibiotics.
Acurx has previously announced a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat. The company is now planning to advance into international Phase 3 clinical trials and is preparing to submit requests for guidance to initiate clinical trials in the EU, UK, Japan, and Canada.
Acurx Pharmaceuticals (NASDAQ: ACXP), a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult-to-treat bacterial infections, has announced a conference call to discuss its second quarter 2024 financial results. The call is scheduled for August 9, 2024, at 8:00 am ET, before the U.S. financial markets open.
The company's President and CEO, David P. Luci, along with CFO Robert G. Shawah, will host the call to present the financial results and provide a business update. Investors and interested parties can join the call using the provided toll-free number for U.S. participants or international access numbers.
Acurx Pharmaceuticals (NASDAQ: ACXP) presented results from the ibezapolstat Phase 2 clinical trial for C. difficile Infection (CDI) at the 17th Biennial Congress of the Anaerobe Society of the Americas. The study showed favorable gut microbiome changes, including increased Actinobacteria in treated patients. Results were consistent with earlier studies, demonstrating preservation of beneficial bacteria. Dr. Kevin Garey highlighted the robust microbiome development plan, predicting an anti-recurrence effect of ibezapolstat. The company is preparing for Phase 3 clinical trials following a successful FDA End-of-Phase 2 Meeting, with plans to expand internationally.
Acurx Pharmaceuticals (NASDAQ: ACXP) has announced the successful conclusion of an FDA End-of-Phase 2 meeting, allowing the advancement of ibezapolstat for the treatment of C. difficile Infection (CDI) to Phase 3 clinical trials. The FDA agreed on key trial elements including protocol design and patient population. The trials will involve 450 subjects using a Modified Intent-To-Treat (mITT) population. Ibezapolstat has received FDA's QIDP and Fast-Track Designation and recently obtained SME designation from the European Medicines Agency, enabling fee incentives for EU Marketing Authorization. Plans include initiating trials in the EU, UK, Japan, and Canada.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced its Q1 2024 financial and operational results, highlighting significant progress in its clinical trials and business operations.
Key achievements include positive data from the Phase 2b trial of ibezapolstat, which showed superior results over vancomycin for treating CDI, with a 94% eradication rate of C. difficile by Day 3. The FDA has agreed on the Phase 3 program and NDA filing pathway. The European Medicines Agency designated Acurx as an SME, providing fee reductions and support.
Financially, Acurx ended Q1 2024 with $8.9 million in cash, up from $7.5 million at the end of 2023. The company reported a net loss of $4.4 million, driven by increased R&D and G&A expenses. 1,121,793 shares were sold under ATM financing, raising $4.4 million.
Further data and presentations are anticipated throughout 2024 at several scientific conferences.
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