This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.

Start Date01 Sep 2026

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

NCT07120490

/ Not yet recruitingNot ApplicableIIT

Multicenter, Randomized, Open-label, Three-arm Study on the Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in the Treatment and Relapse Prophylaxis of Clostridioides Difficile Infection. STOP-CDI Study

The STOP-CDI study is a multicenter, randomized, open-label, three-arm clinical trial comparing the efficacy of fecal microbiota transplantation (FMT) preceded by vancomycin, fidaxomicin monotherapy, and standard-of-care vancomycin in preventing recurrence of Clostridioides difficile infection (CDI) in high-risk adult patients.
CDI is a common healthcare-associated infection with rising incidence and high recurrence rates, particularly in elderly and immunocompromised individuals. While current guidelines recommend fidaxomicin as first-line therapy, its availability and reimbursement remain limited in some healthcare systems. FMT, although effective, is not widely implemented as first-line treatment. This study addresses the need for comparative, real-world data to inform treatment decisions for patients at high risk of severe or recurrent CDI.
Eligible participants include adults aged ≥65 years or younger patients with specific risk factors such as multiple comorbidities, prior CDI episodes, recent hospitalization, use of non-CDI antibiotics, or PPI therapy. Participants will be randomized in a 2:1:1 ratio to one of three treatment arms: (1) vancomycin plus FMT, (2) fidaxomicin, or (3) vancomycin alone. FMT is administered via capsules or, if necessary, alternative endoscopic routes.
The primary endpoint is CDI recurrence within 12 weeks following the initial treatment. Secondary endpoints include clinical cure, safety, and global cure. Exploratory analyses will assess microbiome changes and potential genomic predictors of response. A total of 424 participants will be enrolled across 10 clinical sites in Poland.
The study aims to provide robust, comparative evidence to support clinical guidelines and improve outcomes for patients with CDI, particularly in healthcare systems with limited access to novel therapies.

Start Date01 Oct 2025

Sponsor / Collaborator

Warszawski Uniwersytet Medyczny

[+1]

CTR20252625

/ CompletedNot Applicable

评估非达霉素片（规格：200 mg）受试制剂与参比制剂（DIFICID®）在健康成年受试者餐后状态下的生物等效性研究

[Translation] A study to evaluate the bioequivalence of the test formulation of Fidaxomicin Tablets (strength: 200 mg) and the reference formulation (DIFICID®) in healthy adult subjects in the fed state

研究餐后状态下单次口服受试制剂非达霉素片（规格：200 mg）与参比制剂非达霉素片（DIFICID ®，规格：200 mg）在健康受试者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性和安全性。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral dose of the test preparation Fidaxomicin Tablets (strength: 200 mg) and the reference preparation Fidaxomicin Tablets (DIFICID ®, strength: 200 mg) in healthy subjects in the fed state, and to evaluate the bioequivalence and safety of the two preparations in the fed state.

Start Date10 Jul 2025

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

100 Clinical Results associated with Fidaxomicin

100 Translational Medicine associated with Fidaxomicin

100 Patents (Medical) associated with Fidaxomicin

705

Literatures (Medical) associated with Fidaxomicin

01 Sep 2026·GASTROENTEROLOGY CLINICS OF NORTH AMERICA

Non-Fecal Microbiota Transplantation Strategies for Treatment of Recurrent Clostridioides difficile Infection

Review

Author: Stollman, Neil ; Adamopoulos, Athena

Clostridioides difficile infection (CDI) is a leading healthcare-associated illness with significant recurrence rates and clinical burden. Recurrent CDI (rCDI) arises from microbiota disruption, often exacerbated by antibiotic therapy. Current treatment strategies include fidaxomicin and vancomycin taper regimens, with adjunctive options such as rifaximin in select cases. Preventive approaches focus on environmental decontamination and microbiome preservation. Emerging therapies, including live biotherapeutics, non-toxigenic strains, and microbiome-protective agents, show promise in reducing recurrence. Dietary interventions that enhance microbial diversity may also support recovery. Together, these strategies highlight a shift toward microbiome-centered management of rCDI.

02 Sep 2026·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Clinical failure of an extended-pulsed fidaxomicin regimen associated with emergence of a Clostridioides difficile isolate with reduced fidaxomicin susceptibility in an elderly man

Article

Author: Cadnum, Jennifer L. ; Hausman, Bryan ; Hwang, Munok ; Donskey, Curtis J. ; Redmond, Sarah N. ; Jinadatha, Chetan ; Kaple, Claire E. ; Choi, Hosoon ; Chatterjee, Piyali

ABSTRACT:

The clinical significance of Clostridioides difficile isolates with reduced fidaxomicin susceptibility is uncertain. We report treatment failure of extended-pulsed fidaxomicin treatment during every other day pulsing associated with emergence of a C. difficile isolate with reduced fidaxomicin susceptibility and a novel rpoC gene mutation, resulting in a novel amino acid substitution (R89K). The reduced susceptibility isolate had no reduction in growth or ability to colonize mice, but in vitro sporulation and toxin production were reduced.

08 Jul 2026·JOURNAL OF CLINICAL MICROBIOLOGY

A sensitive and reduced-cost culture medium for recovery of Clostridioides difficile isolates with reduced fidaxomicin susceptibility from stool

Article

Author: Cadnum, Jennifer L. ; Hwang, Munok ; Donskey, Curtis J. ; Jinadatha, Chetan ; Redmond, Sarah N. ; Kaple, Claire E. ; Choi, Hosoon ; Jencson, Annette L.

ABSTRACT:

Emergence of resistance to fidaxomicin is a threat to current treatment algorithms for Clostridioides difficile infection (CDI), but current surveillance methods are labor-intensive and expensive. We tested the hypothesis that C. difficile Brucella agar (CDBA) media supplemented with 1 µg/mL fidaxomicin (CDBA-F1) would provide a sensitive, selective, and cost-effective method to screen stool specimens for C. difficile isolates with reduced fidaxomicin susceptibility (minimum inhibitory concentration > 2 µg/mL). Clinical stool specimens testing positive for C. difficile ( N = 126) were plated on CDBA and CDBA-F1; C. difficile isolates recovered were tested for fidaxomicin susceptibility using agar dilution. The sensitivity of CDBA-F1 in comparison to CDBA was 100% for recovery of isolates with reduced fidaxomicin susceptibility (eight of eight detected). Breakthrough growth of stool microbiota was common, but most breakthrough organisms were easily distinguishable from C. difficile by colony morphology. Use of CDBA-F1 could provide a sensitive and selective media for detection of C. difficile isolates with reduced susceptibility while substantially reducing labor and supply costs.

IMPORTANCE:

C. difficile isolates with reduced fidaxomicin susceptibility may emerge during CDI therapy and, in some cases, result in treatment failure. We report that supplementation of C. difficile selective media with fidaxomicin results in an effective, efficient, and reduced cost method to screen stool for isolates with reduced fidaxomicin susceptibility. Use of this approach could dramatically increase capacity to conduct surveillance for reduced fidaxomicin susceptibility in C. difficile .

News (Medical) associated with Fidaxomicin

17 Aug 2026

·www.prnewswire.com

Acurx Pharmaceuticals Receives FDA Conditional Acceptance and USPTO Trademark Allowance for the Company's Brand Name for Ibezapolstat

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

Phase 3Phase 2Fast TrackClinical Result

17 Aug 2026

·taxispharma.com

TAXIS Pharmaceuticals Receives NIH SBIR Grant to Advance Development of Novel Antibiotic Class for Clostridioides difficile Infections

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.

Fast TrackPhase 1Qualified Infectious Disease Product

14 Aug 2026

·www.prnewswire.com

Acurx Pharmaceuticals, Inc. Reports Second Quarter 2026 results and provides business update

STATEN ISLAND, N.Y., Aug. 14, 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, announced today certain financial and operational results for the second quarter ended June 30, 2026. Highlights of the second quarter ended June 30, 2026, or in some cases shortly thereafter, include: In April 2026, the Company announced the closing of a registered direct offering of 825,085 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $3.03 per share (or pre-funded warrant in lieu thereof) priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued unregistered short-term warrants to purchase up to 1,650,170 shares of common stock. The short-term warrants have an exercise price of $2.78 per share, and are immediately exercisable upon issuance and will expire twenty-four months following the effective date of the registration statement registering the resale of the shares of common stock underlying the short-term warrants. This additional funding when coupled with the remaining availability under our Equity Line of Credit ensures that the Company has the financial resource to conduct the exploratory clinical trial in recurrent C. difficile infection. In April 2026, a scientific poster was presented at the 35th Congress of ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) held in Munich, Germany from April 17-21, 2026 showing that Acurx's orally absorbed DNA pol IIIC inhibitors in preclinical development have the unexpected benefit of gut microbiome preservation while demonstrating systemic antibacterial activity. Dr. Khurshida Begum, Research Scientist, University of Houston College of Pharmacy presented the poster demonstrating potentially therapeutic plasma levels, reduction of MRSA tissue burden and maintaining a substantially higher gut microbial diversity and community structure similar to baseline and distinct from linezolid. In July 2026, the Company's research and development team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single phase 3 study and its acceptability as a pivotal trial for filing a New Drug Application (or NDA), the favorable outcome of which we provided in detail in our press release dated August 3, 2026. In July 2026, presentation of scientific data was provided at the 18th Biennial Congress of the Anaerobe Society of the Americas held at Columbia University Irving Medical Center in New York City by Dr. Kevin Garey and his team from the University of Houston. Data showed that following treatment with ibezapolstat (IBZ), the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, IBZ and fidaxomicin were superior in biofilm experimental models with IBZ significantly more effective at killing C. difficile than vancomycin and fidaxomicin. In July 2026, we signed a continuation of our scientific partnership with Leiden University Medical Center to advance development of Acurx's DNA polymerase IIIC (pol IIIC) Inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx. This new partnership will enable extending mechanistic research into DNA pol IIIC inhibition to accelerate the development of novel new agents that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics. This new research also aims to generate the first-ever 3D structure of Pol C from methicillin-resistant Staphylococcus aureus (MRSA) in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen. In August 2026, the Company received FDA Conditional Acceptance and USPTO Trademark Allowance of its proprietary name for ibezapolstat for the treatment and reduction of recurrence of C. difficile infection. In August 2026, we announced that the Japan and Mexico Patent Offices granted new patents, respectively, which cover DNA pol IIIC inhibitors including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to our expanding series of granted patents in the U.S. and internationally. To date, Acurx has secured six U.S. patents and an additional ten patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key aspects of the Company's ibezapolstat and the ACX‑375C program targeting DNA Polymerase IIIC. Additional country‑level patent applications remain under review. Second Quarter 2026 Financial Results Cash Position: The Company ended the quarter with cash totaling $10.7 million, compared to $7.6 million as of December 31, 2025. During the quarter, the Company raised a total of approximately $2.5 million of gross proceeds through a Registered Direct Offering, as well as $0.8 million under the Equity Line of Credit. R&D Expenses: Research and development expenses for the three months ended June 30, 2026 were $1.1 million compared to $0.5 million for the three months ended June 30, 2025, an increase of $0.6 million. The increase was due primarily to an increase in manufacturing costs of $0.3 million, and an increase in consulting costs of $0.3 million as a result of costs associated with the new recurrent CDI trial program. For the six months ended June 30, 2026, research & development expenses were $1.4 million compared to $1.1 million for the six months ended June 30, 2025. The $0.3 million increase was due primarily to a $0.1 million increase in consulting fees and a $0.2 million increase in manufacturing costs as a result of costs associated with the new recurrent CDI trial program. G&A Expenses: General and administrative expenses for the three months ended June 30, 2026 were $1.2 million compared to $1.7 million for the three months ended June 30, 2025, a decrease of $0.5 million. The decrease was primarily due to a $0.3 million decrease in professional fees, a $0.1 million decrease in legal costs, and a $0.1 million decrease in share-based compensation expense. For the six months ended June 30, 2026, general and administrative expenses were $2.6 million compared to $3.3 million for the six months ended June 30, 2025, a decrease of $0.7 million. The decrease was due primarily to a $0.3 million decrease in professional fees, $0.2 million decrease in legal costs, and $0.2 million decrease in share-based compensation expense. Net Income/Loss: The Company reported a net loss of $2.3 million or $0.53 per diluted share for the three months ended June 30, 2026 compared to a net loss of $2.2 million or $1.89 per diluted share for the three months ended June 30, 2025. For the six months ended June 30, 2026, the Company reported a net loss of $3.9 million or $1.13 per diluted share, compared to $4.4 million or $4.01 per diluted share for the six months ended June 30, 2025, all for the reasons previously mentioned. Conference Call As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: Date: Friday, August 14, 2026 Time: 8:00 a.m. ET Toll free (U.S.): 1-877-790-1503; Access ID: 13761686 International: Click here for participant international Toll-Free access numbers About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for advancement into international Phase 3 clinical trials to treat patients with acute C. difficile Infection (CDI) and it is also preparing for a ground-breaking clinical trial targeting the prevention of recurrent CDI (rCDI). If successful, ibezapolstat will change the treatment paradigm for CDI and rCDI by providing one therapy for the full spectrum of CDI and rCDI from first occurrence to multiply recurrent episodes. 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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization. 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 January 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 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. The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 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. 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 uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, 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 & Chief Executive Officer Tel: 917-533-1469 Email: [email protected] SOURCE Acurx Pharmaceuticals, Inc. 21% more press release views with Request a Demo

Phase 3Financial StatementFast Track

100 Deals associated with Fidaxomicin

External Link

KEGG	Wiki	ATC	Drug Bank
D09394	Fidaxomicin	A07AA12	DB08874

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Enterocolitis, Pseudomembranous	Japan	Zeria Pharmaceutical Co., Ltd.	02 Jul 2018
Infectious enteritis	Japan	Zeria Pharmaceutical Co., Ltd.	02 Jul 2018
Infectious enteritis	Japan	Astellas Pharma, Inc.	02 Jul 2018
Clostridium difficile infection	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	23 Apr 2013
Clostridium difficile diarrhea	European Union	Tillotts Pharma AG	05 Dec 2011
Clostridium difficile diarrhea	Iceland	Tillotts Pharma AG	05 Dec 2011
Clostridium difficile diarrhea	Liechtenstein	Tillotts Pharma AG	05 Dec 2011
Clostridium difficile diarrhea	Norway	Tillotts Pharma AG	05 Dec 2011
Clostridium Infections	United States	Cubist Pharmaceuticals LLC	27 May 2011
Diarrhea	United States	Cubist Pharmaceuticals LLC	27 May 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	-	Optimer Pharmaceuticals LLC	10 Oct 2012
Staphylococcal Infections	Preclinical	United States	Optimer Pharmaceuticals LLC	-

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2026	Not Applicable	Clostridium difficile infection	1,270	Fidaxomicin	ongsmtbgjg(yyjptksqtl) = tdseruqqah nuuzzcbzym (tcepiolyce ) View more	Negative	02 May 2026
				Oral Vancomycin	ongsmtbgjg(yyjptksqtl) = bgpbjsetbj nuuzzcbzym (tcepiolyce ) View more
NCT02667418 (VA Cooperative Studies Program (CSP) #596 \| OpTION, CTgov)	Phase 4	Clostridium difficile infection	308	Fidaxomicin (Fidaxomicin)	xvduaqbsdc = cyavrfcmho hywsqyvsek (yviphesxqo, ipmbphulaa - okzxscehiu) View more	-	12 Nov 2025
				Vancomycin with Taper/Pulse (Vancomycin T/P)	xvduaqbsdc = wgceywvzqo hywsqyvsek (yviphesxqo, rfhzyuxfau - jybgullvdz) View more
DDW2025 \| ECCO2025	Not Applicable	Clostridium difficile infection	96	Fidaxomicin	nzwrywlyjd(kadguwrenc) = epfffnpajr xmasxfacwe (voltqqpjuk ) View more	Positive	03 May 2025
NCT02692651 (Pubmed \| Clin Infect Dis) Manual	Phase 4	Clostridium difficile infection	144	Fidaxomicin	wjfstfgcsm(wjxnmnjnfx) = psgmwccsep bgwfpjzetv (vlxvkncezu ) View more	Negative	17 Feb 2024
				Vancomycin	wjfstfgcsm(wjxnmnjnfx) = hrdeoutcyr bgwfpjzetv (vlxvkncezu ) View more
NCT02395848 (CTgov)	Phase 3	Clostridium difficile infection	31	Fidaxomicin	jqfrzfiqxt = qxqljkhxtx dvyglcflps (sbgnxqcywp, wwxljomlfn - hmvgzxgzlq) View more	-	24 Mar 2023
NCT03760484 (CTgov)	Phase 2	Clostridium difficile infection	4	fecal microbiota transplantation (FMT)+Fidaxomicin 200 mg	xifijxdztu = kbdtekpznk ocqzqibfch (noucljvwsl, sljopvyhrp - fcgajhzgls) View more	-	13 Dec 2022
NCT02692651 (CTgov)	Phase 4	Sepsis \| Clostridium difficile infection	144	Fidaxomicin (Fidaxomicin)	wkyymbwtae = bfznpaxxdz xxqazvrfxd (greqdhiszk, dzonwwrkll - bxsqsgkpgp) View more	-	25 Mar 2022
				Vancomycin (Vancomycin)	wkyymbwtae = tufxoqfjep xxqazvrfxd (greqdhiszk, dxiytghygh - ueumcdxjtr) View more
NCT02214771 (DAFNE, Pubmed \| J Int Med Res)	Not Applicable	Clostridium difficile infection	296	Fidaxomicin	wdyeeopwwo(udiblvturz) = hvsotdewce mornaaplwd (jyfxflmttn ) View more	-	01 Jun 2021
NCT02218372 (SUNSHINE, Pubmed \| Clin Infect Dis) Manual	Phase 3	Clostridium difficile infection	142	Fidaxomicin	wnpfipguaa(pqxjyhmlvv) = pxlwwkqcht ixbipcaauo (ppzyzlrrbe ) View more	Superior	17 Dec 2020
				Vancomycin	wnpfipguaa(pqxjyhmlvv) = uxvjzprexy ixbipcaauo (ppzyzlrrbe ) View more
NCT02057198 (C-Diff, CTgov)	Phase 4	Diarrhea \| Clostridium difficile colitis \| Enterocolitis	33	Fidaxomicin (Fidaxomicin)	ehcergifjc(fnnpbuibau) = envceibbba ehhodmwslx (rjmnruylry, arzjlufsey - bsichlpbzp) View more	-	02 Oct 2019
				Metronidazole (Metronidazole)	ehcergifjc(fnnpbuibau) = jetojxxefi ehhodmwslx (rjmnruylry, labqjnntzd - zjweenegni) View more

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