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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.
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.
Acurx Pharmaceuticals (NASDAQ: ACXP), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, has announced that it will discuss its third quarter 2024 financial results on Wednesday, November 13, 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 a conference call to discuss the results and provide a business update.
Interested parties can join the call using the following details:
- Toll-free (U.S.): 877-790-1503
- International: Participant international Toll-Free access numbers available via provided link
- Conference ID: 13749688
New to The Street, a leading U.S. business television platform, has renewed its media partnership with Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP), a late-stage biopharmaceutical company. The new series includes broadcast television interviews, earned media placements, and a comprehensive outdoor advertising campaign.
Acurx Pharmaceuticals will be featured on New to The Street's national television broadcasts, highlighting the company's latest developments and leadership in addressing critical bacterial infections through innovative antibiotics. The coverage will air across major networks, enhancing Acurx's visibility in the biopharmaceutical sector.
The partnership also includes targeted earned media placements and outdoor advertising support, featuring billboard placements in strategic locations like Times Square and the Financial District. The media series is set to begin airing immediately in 2024, with outdoor and earned media elements running concurrently to maximize audience reach.
New to The Street announces its upcoming sponsored programming on Bloomberg TV, airing Saturday, October 12, at 6:30 PM EST. The lineup features innovative companies including ZAPP, NUBURU, and ACURX Pharmaceuticals, showcasing advancements in electric vehicles, blue laser technology, and antibiotic innovation respectively. The program will also include The Sustainable Green Team highlighting eco-friendly solutions for environmental sustainability, and SEKUR returning with its "Hack of the Week" segment, focusing on cybersecurity threats and privacy protection.
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