Vancomycin Hydrochloride

The proposed proprietary name, or brand name, CIFBEZY has received conditional acceptance from the FDA and also federal trademark allowance from the USPTO These initial milestones will form the basis for the commercial identity of Acurx's lead product candidate, ibezapolstat, as the Company prepares to advance it toward its international Phase 3 registration program for both the acute treatment and reduction of recurrence in C. difficile Infection (CDI) As required, a request for final FDA review and approval of the brand name will be submitted at time of marketing application for the NDA STATEN ISLAND, N.Y., Aug. 17, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed proprietary, or brand name, CIFBEZY for ibezapolstat, the Company's lead antibiotic product candidate being developed for both the acute treatment and the reduction of recurrence of CDI. The Company also announced that the U.S. Patent and Trademark Office (USPTO) has allowed the trademark application for CIFBEZY. These independently-determined initial milestones to establish the proprietary name for ibezapolstat consider both regulatory and intellectual-property aspects. For the regulatory aspect, commercial use is contingent upon approval of a US NDA (New Drug Approval) and is focused on patient safety and the prevention of medication errors. For the intellectual property aspect, the notice of allowance shows that the trademark has passed through both the examination process and the opposition period. Securing both a registration and proprietary name will provide Acurx with a protected brand name as it advances ibezapolstat into international Phase 3 clinical trials toward an NDA approval and ultimate commercialization. The proprietary name CIFBEZY (pronounced "sif-BEZ-ee") was developed through an extensive screening process involving external branding experts, prescribers, pharmacists and linguists, as required and evaluated by FDA's Division of Medication Error Prevention and Analysis (DMEPA) consistent with the FDA's Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names. "Receiving both FDA conditional acceptance and USPTO trademark allowance for CIFBEZY are meaningful milestones as a placeholder that move ibezapolstat one step closer to preparation for commercialization" said Robert J. DeLuccia, Acurx's Executive Chairman: "With ibezapolstat preparing to advance into its international Phase 3 registration program for treatment of both CDI and reduction of recurrence and the initiation of a ground-breaking clinical trial in patients with multiply-recurrent CDI (rCDI), we believe ibezapolstat has the potential to be the first anti-CDI antibiotic to demonstrate clinical success for both acute treatment and reduction of recurrence of C. difficile infection. Such success has the potential to shift the paradigm of treatment and prevention of rCDI from two treatments to one and if approved would be a game changer offering substantial in-market competitiveness." About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. Acurx has received FDA guidance in meeting minutes from a July 13, 2026 Type C Meeting to discuss ibezapolstat's (IBZ) Phase 3 clinical program, including the potential to submit an NDA (New Drug Application) based on a single Phase 3 trial and a clinical trial design intended to support indications for both treatment and reduction of recurrence of Clostridioides difficile infection (CDI). FDA stated that it is open to further discussion on the totality of evidence from the clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial and any other clinical trials conducted prior to the pre-NDA meeting, particularly if the clinical efficacy results are robust. Additionally, the Agency agreed that a successful clinical outcome from a single IBZ-ASPIRE Phase 3 trial, supported by the open-label IBZ-PATHFINDER Phase 2 trial in multiply-recurrent CDI (rCDI) will allow NDA filing for both the acute treatment and the reduction of recurrence of CDI. Trial start-up activities for the IBZ-PATHFINDER ground-breaking clinical trial in patients with rCDI have been initiated with patient enrollment expected to begin in the next few months. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile infection. Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see ). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 2a trial, including the treatment-related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism. (Data published in Lancet, August 2025 (25)00054-0/fulltext). About Clostridioides difficile Infection (CDI) and Recurrent CDI (rCDI) According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care-associated infections in U.S. hospitals (Lessa, 2015, NEJM). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 30,000 deaths annually. (Guh, 2020, NEJM. Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%. In recent studies, rCDI ranges from 4% to 19.5% following treatment with fidaxomicin and 17 to 27% following treatment with vancomycin. In patients with multiple prior episodes of CDI, rCDI following treatment with vancomycin is even more problematic, with an incidence of up to 40%. Consequently, the principal unmet medical need in this disease is the prevention of recurrence. The estimated annual public health cost burden in the U.S. annually is ~$5 billion annually with ~$2.8 billion due to recurrent CDI. About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat- treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit . Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and described in the Company's annual report on Form 10-K for the year ended December 31, 2025 as filed with the Securities and Exchange Commission on March 12 2026, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci, President & CEO Tel: 917-533-1469 Email: [email protected] SOURCE Acurx Pharmaceuticals, Inc. 21% more press release views with Request a Demo

MIAMI, FL — Aug. 17, 2026 — TAXIS Pharmaceuticals, a clinical-stage company at the forefront of developing investigational therapies to treat multidrug-resistant bacterial infections and combat antimicrobial resistance (AMR), announced today that it has received a Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), one of the institutes of the National Institutes of Health (NIH). The grant is valued at approximately $562,037, with the potential for up to $3 million in additional Phase II funding upon successful achievement of program milestones. The grant will support the development of TAXIS Pharmaceuticals’ investigational 3-alkoxy benzamide class of narrow-spectrum FtsZ inhibitors designed to combat Clostridioides difficile (C. difficile), including toxigenic and hypervirulent strains associated with severe disease and high recurrence rates. The award represents the company’s third NIH SBIR grant in 27 months and will support continued advancement of its investigational FtsZ inhibitor program, which targets one of the most significant unmet needs in infectious disease. “This NIH award further validates our scientific approach and strengthens our efforts to develop innovative therapies for some of the most challenging bacterial infections facing patients today,” says Gregory G. Mario, MBA, President and CEO of TAXIS Pharmaceuticals. “Receiving our third NIH SBIR grant in just over two years reflects both the quality of our science and the urgent need for new therapeutic options to address antimicrobial resistance and serious infectious diseases.“ C. difficile infection (CDI) is responsible for an estimated 500,000 illnesses and 30,000 deaths in the United States each year.(1) Hypervirulent strains have contributed to increasingly severe disease, while recurrence remains a major concern for patients and healthcare providers. Current frontline therapies, including metronidazole, vancomycin, and fidaxomicin, are broad-spectrum antibiotics that can disrupt the gut microbiome, potentially creating conditions that allow C. difficile to re-establish and contribute to recurrent infection.(2) TAXIS Pharmaceuticals’ investigational FtsZ inhibitors are designed to selectively target toxigenic and hypervirulent C. difficile strains while preserving beneficial gut bacteria. FtsZ, an essential bacterial cell division protein not found in human cells, represents an attractive target for antibiotic development. The company’s proprietary 3-alkoxy benzamide scaffold has demonstrated potent activity against hypervirulent and drug-resistant C. difficile strains in preclinical studies. By preserving the integrity of the gut microbiome, TAXIS’ investigational approach aims to address one of the key challenges associated with CDI treatment: recurrence. The company believes this differentiated strategy may offer an important advancement over existing broad-spectrum therapies. “Our investigational FtsZ inhibitor program represents a novel approach to treating C. difficile infections by selectively targeting pathogenic strains while preserving the beneficial bacteria that support a healthy gut microbiome,” says Ajit Parhi, PhD, Chief Scientific Officer of TAXIS Pharmaceuticals and Principal Investigator on the project. “This NIH grant will allow us to advance critical preclinical development activities and further evaluate the potential of this program.“ In May of 2025, TAXIS received a $2.9 million NIH grant to advance development of its dihydrofolate reductase inhibitors (DHFRIs) for multidrug-resistant gonorrhea. In May of 2024, TAXIS received a $2.67 million NIH grant to support development of its investigational efflux pump inhibitors (EPIs) designed to restore the effectiveness of existing antibiotics against resistant bacterial infections. Together with its FtsZ inhibitor platform, these programs reflect TAXIS’ broader mission to develop innovative solutions to address the escalating global burden of antimicrobial resistance. Research mentioned in this press release was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health Under Award Number 1R43AI197297-01. The content is solely the responsibility of the authors and does not necessarily represent the views of the National Institutes of Health. About TAXIS Pharmaceuticals TAXIS Pharmaceuticals is a clinical-stage company developing new classes of anti-resistance therapies to treat life-threatening, multidrug-resistant bacterial infections. Our investigational drug candidates—including efflux pump inhibitors, dihydrofolate reductase inhibitors, and FtsZ inhibitors—aim to combat antimicrobial resistance (AMR). TAXIS’ investigational therapies currently target several different bacterial pathogens, many of which are on the World Health Organization Priority Pathogen List. Our mission is to reduce and potentially eliminate the threat of current and emergent antimicrobial resistant bacteria across a wide range of infectious diseases and save lives. To learn more, visit taxispharma.com. Forward-Looking Statements Investors and stakeholders should be aware that this press release contains forward-looking statements and information. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may”, “might”, “will”, “should”, “could”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “project”, “intend”, “future”, “potential” or “continue”, and other similar expressions are intended to identify forward looking statements. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. This press release is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of our securities, or an offer, invitation or recommendation to sell, or a solicitation of an offer to buy, any of our securities in any jurisdiction. Neither this press release nor anything in it shall form the basis of any contract or commitment. This press release is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment objectives, financial situation or needs of any investor. References: 1. Feuerstadt P, Theriault N, Tillotson G. “The burden of CDI in the United States: a multifactorial challenge.” BMC Infect Dis. 2023 Mar 7;23(1):132. Accessed 8 June 2026. 2. Sehgal K, Khanna S. “Gut microbiome and Clostridioides difficile infection: a closer look at the microscopic interface.” Ther Adv Gastroenterol. 2021 Feb 23;14:1756284821994736. Accessed 8 June 2026. Media Contact Jennifer Ringler, TAXIS Pharmaceuticals, 1 973-647-5004, jringler@readhealthy.net, https://taxispharma.com/ TXA709, TAXIS’ lead product candidate, is a novel target – first-ever product to target FtsZ proteins. Oral anti-MRSA agent that completed a Phase I clinical trial with no serious adverse events. Ongoing research focuses on disrupting bacterial cell wall architecture to address drug resistance mechanisms. TXA709 is developed as an anti-resistance drug for combination therapy with obsolete antibiotics. Targets the FtsZ bacterial cell division protein, offering potential for future development against Gram-negative bacteria. Designated a Qualified Infectious Disease Product (QIDP) by the FDA in September 2016. Regulatory incentives include eligibility for Fast Track designation, priority review, and extended marketing exclusivity under the GAIN Act.