Acurx Pharmaceuticals Inc (ACXP)

Acurx - Interview with CEO David Luci -






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Today's Acurx earning conference call summary -


>>> Acurx Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary


Moby Intelligence

May 12, 2026


https://finance.yahoo.com/sectors/healthcare/articles/acurx-pharmaceuticals-inc-q1-2026-170541650.html


Acurx Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary

Strategic Pivot and Clinical Momentum

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Management is transitioning the ibezapolstat program to address both acute and recurrent C. difficile (CDI) as a single-agent solution, aiming to replace the current two-agent treatment model.

The strategic shift is supported by Phase II data showing a 96% cure rate and zero recurrences in cured patients, suggesting a unique ability to spare the microbiome.

A new open-label pilot study in multiply recurrent CDI (rCDI) has been launched to inform the design of a planned Phase III registration trial under the FDA's Limited Population Pathway.

The company is leveraging recent FDA guidance that may allow for a single pivotal trial for marketing approval, potentially accelerating the timeline for the acute CDI population.

Intellectual property was significantly bolstered with new patents in the U.S. and Korea, extending protection for DNA polymerase IIIC inhibitors through at least 2039.

Preclinical data presented at ESCMID Global suggests the company's PolC inhibitor compounds can treat resistant gram-positive infections while maintaining microbial diversity similar to baseline.

Regulatory Strategy and Operational Outlook

Acurx has scheduled a meeting with the FDA to confirm if ibezapolstat qualifies for the new one-trial registration standard based on existing 'confirmatory evidence' of efficacy.

The 20-patient open-label rCDI trial is expected to see its first patient enrollment around August 2026, serving as a precursor to a pivotal Phase III trial.

Management is actively pursuing diverse funding opportunities to support the international Phase III clinical trial program for acute CDI.

Future clinical protocols will emphasize patient diversity and consistency across subgroups to align with FDA preferences for single-trial approval pathways.

The company plans to follow patients for two months post-treatment in upcoming trials to establish a competitive advantage over current standards that typically only measure one-month recurrence.

Capital Position and Risk Factors

The company closed a registered direct offering in April 2026, which, combined with an existing equity line of credit, provides the resources necessary for the exploratory rCDI trial.

R&D expenses decreased to $0.3 million from $0.6 million year-over-year, primarily due to lower manufacturing and consulting costs following prior year trial preparations.

Management acknowledged the challenging macroeconomic environment and industry sector volatility as ongoing factors they must navigate during the Phase III transition.

The company maintains QIDP and Fast Track designations from the FDA, which provide regulatory incentives for their antibiotic pipeline.

Q&A Session Highlights

Formalization of the FDA's one-trial registration standard

Management clarified that while the guidance is finalized for the industry, they must still confirm its specific application to ibezapolstat in an upcoming FDA meeting.

The company believes they meet the 'confirmatory evidence' criteria through mechanistic data, in vitro killing data, and animal models that have historically predicted human efficacy.

Microbiome preservation as a regulatory and competitive factor

While microbiome data is currently an exploratory marker rather than a primary approvable claim, it serves as critical evidence for the drug's mechanism in reducing recurrence.

Ibezapolstat is designed to be 'gentler' on good bacteria that produce bile acids, which naturally suppress C. diff growth, unlike broader antibiotics like vancomycin.

Clinical trial design for recurrence and patient populations

The Phase III trial will follow patients for 8 weeks to match the claims of live biological products like VOWST, rather than the 4-week standard for traditional antibiotics.

The company is expanding its study population to include diverse age, geographic, and ethnic groups to satisfy FDA requirements for a single-trial approval pathway.

Acurx Pharmaceuticals, Inc. Reports First Quarter 2026 results and Provides Business UpdateMay 12, 2026 7:01 AM
PR Newswire (US) STATEN ISLAND, N.Y., May 12, 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 first quarter ended March 31, 2026.  Highlights of the first quarter ended March 31, 2026, or in some cases shortly thereafter, include:In February 2026, we announced that the USPTO granted a new patent for our DNA pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules. This adds to our extensive patent estate for our DNA pol IIIC inhibitors going out in some cases to 2042, subject to extension.In March 2026, we issued a press release announcing that we are starting up a ground-breaking ibezapolstat (IBZ) clinical trial program in patients with recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one.  When coupled with IBZ Phase 2 results of being highly effective (96% clinical cure) in treating acute CDI with 0% recurrence in patients cured of their infection while sparing the gut microbiome, this new clinical trial strategy has the potential to position ibezapolstat to be a new standard of care as the first agent to treat both (acute) CDI and prevent rCDI. This new Phase 2 clinical trial in rCDI builds on ibezapolstat's strength, namely that no patients who were cured of their infection experienced a recurrence. This new trial begins with an open-label pilot study to gain experience with IBZ in up to 20 patients patients with multiply-recurrent CDI who had at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry.Acurx's clinical program in the broader acute CDI patient population is ready to advance to Phase 3 international pivotal clinical trials. In this regard, we're very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [i.e., for registration]'. If formalized by FDA, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial.In March 2026, we announced that the Korean Patent Office granted a new patent which covers 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 its expanding series of granted patents in the U.S. and internationally. To date, Acurx has secured ten patents including five U.S. patents along with patents in Israel, Japan, India, Australia and Korea, all of which protect key aspects of the Company's product pipeline. Also, and very significantly, a new patent was recently issued relating to IBZ and its use to treat CDI while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. Additional country level patent applications remain under review.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.First Quarter 2026 Financial Results Cash Position:   The Company ended the quarter with cash totaling $9.3 million, compared to $7.6 million as of December 31, 2025.   During the quarter, the Company raised a total of approximately $3.1 million of gross proceeds through purchases under the Equity Line of Credit.R&D Expenses:Research and development expenses for the three months ended March 31, 2026 were $0.3 million compared to $0.6 million for the three months ended March 31, 2025, a decrease of $0.3 million.  The decrease was due primarily to a decrease in manufacturing costs of $0.1 million, and a decrease in consulting costs of $0.2 million as a result of the prior year trial preparation related expenses.  G&A Expenses:General and administrative expenses for the three months ended March 31, 2026 were $1.4 million compared to $1.6 million for the three months ended March 31, 2025, a decrease of $0.2 million.  The decrease was primarily due to a $0.1 million decrease in professional fees and a $0.1 million decrease in legal costs.  Net Income/Loss:The Company reported a net loss of $1.7 million or $0.62 per diluted share for the three months ended March 31, 2026 compared to a net loss of $2.1 million or $2.15 per diluted share for the three months ended March 31, 2025, all for the reasons previously mentioned.The Company had 3,389,106 shares outstanding as of March 31, 2026.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:                           Tuesday, May 12, 2026
Time:                           8:00 a.m. ET
Toll free (U.S.):           1-877-790-1503;   Access ID: 13760162
International:               Click here for participant international Toll-Free access numbers
                                    https://www.incommconferencing.com/international-dial-inAbout IbezapolstatIbezapolstat 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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).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 www.acurxpharma.com.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:  davidluci@acurxpharma.comACURX PHARMACEUTICALS, INC.CONDENSED INTERIM BALANCE SHEETS








March 31, 
December 31, 

2026
2025

(unaudited)
(Note 2)ASSETS












CURRENT ASSETS





Cash
$9,254,813
$7,556,100Other Receivable

56,313

48,417Prepaid Expenses

228,826

85,018TOTAL ASSETS
$9,539,952
$7,689,535






LIABILITIES AND SHAREHOLDERS' EQUITY












CURRENT LIABILITIES





Accounts Payable and Accrued Expenses
$2,526,809
$2,420,943TOTAL CURRENT LIABILITIES

2,526,809

2,420,943






TOTAL LIABILITIES

2,526,809

2,420,943






COMMITMENTS AND CONTINGENCIES












SHAREHOLDERS' EQUITY





Preferred Stock; $0.001 par value, 10,000,000 shares authorized, no
shares issued and outstanding at March 31, 2026 and December 31,
2025

—

—Common Stock; $0.001 par value, 250,000,000 shares authorized,
3,389,106 and 2,348,113 shares issued and outstanding at March 31,
2026 and December 31, 2025, respectively

3,389

2,348Additional Paid-In Capital

83,979,230

80,554,738Accumulated Deficit

(76,969,476)

(75,288,494)






TOTAL SHAREHOLDERS' EQUITY

7,013,143

5,268,592






TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
$9,539,952
$7,689,535 ACURX PHARMACEUTICALS, INC.CONDENSED INTERIM STATEMENTS OF OPERATIONS










Three Months Ended



March 31, 



2026
2025



(unaudited)
(unaudited)

OPERATING EXPENSES







Research and Development
$341,468
$598,798

General and Administrative

1,374,522

1,577,686







.

TOTAL OPERATING EXPENSES

1,715,990

2,176,484










OPERATING LOSS

(1,715,990)

(2,176,484)










OTHER INCOME







Interest Income

35,008

27,291










NET LOSS
$(1,680,982)
$(2,149,193)










LOSS PER SHARE







Basic and diluted net loss per common share
$(0.62)
$(2.15)










Weighted average common shares outstanding, basic and diluted

2,718,433

1,001,932

  View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-first-quarter-2026-results-and-provides-business-update-302765686.htmlSOURCE Acurx Pharmaceuticals, Inc. Original: Acurx Pharmaceuticals, Inc. Reports First Quarter 2026 results and Provides Business Update

Acurx Pharmaceuticals to Present at the Alliance Global Partners (A.G.P) Healthcare Company ShowcaseApril 29, 2026 8:00 AM
PR Newswire (US)

STATEN ISLAND, N.Y., April 29, 2026 /PRNewswire/ -- Acurx Pharmaceuticals (Nasdaq: ACXP) (Acurx or the Company), a fully-integrated biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections announced today that David P. Luci, President & Chief Executive Officer, will participate virtually in a fireside chat at A.G.P.'s Healthcare Company Showcase on Wednesday, May 24, 2025.A replay of the presentation will be available under the News / Events tab of the Acurx website following the event at www.acurxpharma.com.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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).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 www.acurxpharma.com.Forward-Looking StatementsAny 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. Forward-looking statements include statements regarding the exercise of the short-term warrants prior to their expiration and the use of proceeds from the offering. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: market and other conditions, 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: davidluci@acurxpharma.co



View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-to-present-at-the-alliance-global-partners-agp-healthcare-company-showcase-302756793.htmlSOURCE Acurx Pharmaceuticals, Inc.

Original: Acurx Pharmaceuticals to Present at the Alliance Global Partners (A.G.P) Healthcare Company Showcase

Acurx Pharmaceuticals, Inc. To Present at The Market Movers Investor SummitApril 27, 2026 8:00 AM
NewsfileStaten Island, New York--(Newsfile Corp. - April 27, 2026) - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it will be participating in the Market Movers Investor Summit on Tuesday May 5, 2026. The presentation will take place at 05:20 PM ET at the historic Bank of New York. David P. Luci, President & Chief Executive Officer, will be giving the presentation.The Market Movers Investor Summit is a premier, high-access event on Wall Street. The inaugural program features fireside chats with Alex Rodriguez, Chairman and CEO of A-Rod Corp, and Grant Cardone, CEO of Cardone Capital, in addition company presentations and one-on-one meetings throughout the day. Event Details:Summit Dates: May 5, 2026Company Presentation: Tuesday, May 5, 2026Time: 05:20 PM ETLocation: 48 Wall Street, New York, NY (The original Bank of New York)Request an invitation to attend at www.marketmoverssummit.com. Summary of Market Movers Investor Summit The 2026 Market Movers Investor Summit begins on May 4th with a kickoff party at the legendary Delmonico's, followed by a full day of programming on May 5th. The summit brings together public and private company executives, fund managers, and family offices for a focused, high-caliber experience. The agenda includes company presentations and one-on-one meetings, exclusive fireside chats and keynote sessions, a pop-up lunch from the legendary Katz Delicatessen, and a surprise musical guest.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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).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 www.acurxpharma.com. Forward-Looking StatementsAny 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. Forward-looking statements include statements regarding the ability of the Company to consummate the offering, the exercise of the short-term warrants prior to their expiration, the satisfaction of the closing conditions of the offering, and the use of proceeds therefrom. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: market and other conditions, 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: davidluci@acurxpharma.comSource: Acurx Pharmaceuticals, Inc.To view the source version of this press release, please visit https://www.newsfilecorp.com/release/294135
Original: Acurx Pharmaceuticals, Inc. To Present at The Market Movers Investor Summit

Korean Patent Office Grants Acurx Pharmaceuticals New Patent for DNA Polymerase IIIC InhibitorsMarch 30, 2026 7:01 AM
PR Newswire (US)

STATEN ISLAND, N.Y., March 30, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that the Korean Intellectual Property Office (KIPO) has granted a new patent which covers DNA Polymerase 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 its expanding series of granted patents in the U.S. and abroad. To date, Acurx has secured four U.S. patents, along with granted patents in Israel, Japan, India, Australia and Korea, all of which protect key aspects of the Company's ACX-375C program targeting DNA Polymerase IIIC. Additional country-level patent applications remain under review.Robert J. DeLuccia, Executive Chairman of Acurx, stated: "Achieving this new patent extends our patent estate protection as we further develop our innovative, AI-supported drug discovery platform. We believe Acurx's preclinical pipeline of systemically-absorbed compounds has the potential to create a transformational shift in the treatment paradigm of serious and potentially life-threatening infections such as acute bacterial skin and skin-structure infections (ABSSSI, including MRSA), Community-acquired bacterial pneumonia (CABP), hospital and/or ventilator-associated bacterial pneumonia (HABP/VABP), bacteremia with or without sepsis and/or infectious endocarditis, bone/joint infections, prosthetic joint infections and inhalational anthrax, caused by B. anthracis, a Bioterrorism Category A Threat-Level pathogen. Recently presented microbiome selectivity data on representative novel compounds provide initial evidence that microbiome selectivity, when compared to the comparator antibiotic, linezolid, may be a class effect."He further stated: "Our lead DNA pol IIIC inhibitor, ibezapolstat, is ready to advance to international, Phase 3, pivotal registration trials in the US and EU for oral treatment of acute C. difficile Infection. We're also starting up a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the treatment paradigm for acute CDI and rCDI from two agents to one."  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-positive 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 is Phase 3 ready with plans in progress to begin international clinical trials as soon as possible. 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 www.acurxpharma.comForward-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 & CEO
Tel: 917-533-1469
Email: davidluci@acurxpharma.com



View original content:https://www.prnewswire.com/news-releases/korean-patent-office-grants-acurx-pharmaceuticals-new-patent-for-dna-polymerase-iiic-inhibitors-302728007.htmlSOURCE Acurx Pharmaceuticals, Inc.

Original: Korean Patent Office Grants Acurx Pharmaceuticals New Patent for DNA Polymerase IIIC Inhibitors

ACXP.............................https://stockcharts.com/sc3/ui/?s=ACXP&p=W&b=5&g=0&id=p86431144783

Acurx Pharmaceuticals Reports Stronger Cash Position and Clinical Progress in Q4 2025March 13, 2026 11:39 AM
IH Market News
Acurx Pharmaceuticals (NASDAQ:ACXP) reported fourth-quarter and full-year 2025 results highlighting a stronger cash position and continued progress in the development of its lead antibiotic candidate, ibezapolstat, for the treatment of Clostridioides difficile infection (C. difficile).The company said its cash balance more than doubled year over year, reaching $7.6 million as of December 31, 2025, compared with $3.7 million at the end of 2024. Management attributed the increase to capital raises and tighter cost controls implemented throughout the year.Research and development spending declined significantly as part of those efforts. R&D expenses totaled $0.3 million in the fourth quarter of 2025, down from $0.8 million in the same period a year earlier, reflecting a strategic focus on prioritizing key clinical programs.Acurx also reported a net loss of $1.6 million for the quarter, an improvement of roughly 43% compared with Q4 2024.



Clinical progress with ibezapolstat



The company continues to advance ibezapolstat, its oral antibiotic candidate targeting C. difficile infections. According to the company, the drug demonstrated a 96% clinical cure rate in Phase 2 trials, supporting its potential as a differentiated treatment in a market where recurrence remains a major challenge.Acurx said it plans to launch a new clinical trial program focused on recurrent C. difficile infection (rCDI). The trial aims to evaluate whether ibezapolstat could support a shift toward single-agent therapy, reducing dependence on multi-drug regimens and potentially lowering recurrence rates.



Market reaction



Despite the operational progress, Acurx shares fell about 15% in premarket trading following the earnings release, dropping to $5.01 from the previous close of $6.03.The decline followed an unusually volatile period for the stock. Over the prior week, shares had surged more than 270%, and the stock remains over 100% higher year-to-date.Analysts note that the sharp pullback may reflect profit-taking after the recent rally or broader market uncertainty rather than concerns about the company’s clinical progress.



Outlook



Looking ahead, Acurx plans to focus on advancing ibezapolstat through its next phase of clinical development while maintaining disciplined cost management.Analysts covering the company maintain a consensus “Strong Buy” rating, with price targets ranging widely from $4 to $31, reflecting both the potential upside from successful clinical development and the risks associated with early-stage biotechnology programs.



Executive commentary



“Our financial position has strengthened considerably, allowing us to focus on advancing our clinical programs. We are committed to addressing the urgent need for effective C. difficile treatments,” said David Luci, President and Chief Executive Officer of Acurx Pharmaceuticals.



Key risks



Acurx faces several challenges common to development-stage biotech companies, including the need for additional capital to support future clinical trials, competition from larger pharmaceutical firms, and potential regulatory hurdles in securing approval for ibezapolstat.During the earnings call, analysts also questioned management about cash management and the expected timeline for upcoming trials. Company executives said they intend to maintain financial flexibility while continuing to progress their research pipeline.Acurx Pharmaceuticals stock price

Original: Acurx Pharmaceuticals Reports Stronger Cash Position and Clinical Progress in Q4 2025

Acurx Pharmaceuticals, Inc. Reports Full Year and Fourth Quarter Results and Provides Business UpdateMarch 13, 2026 7:01 AM
PR Newswire (US)

STATEN ISLAND, N.Y., March 13, 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 full year and fourth quarter ended December 31, 2025.Highlights of the fourth quarter ended December 31, 2025, or in some cases shortly thereafter, include:In October 2025, the Company received gross proceeds from the exercise of 170,068 Series F Warrants of approximately $1.4 million.Also in October 2025, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline. Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, and Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program. The Company's presentation included an update on ibezapolstat and its microbiome sparing properties. Also, presented were new colonic-microbiome data from a "state-of-the-art" mouse infection model showing a potential microbiome-sparing class effect of representative compounds from our DNA pol IIIC inhibitor preclinical pipeline.In November 2025, the Company announced that the Nature Communications Scientific Journal published results from its scientific collaboration with Leiden University Medical Center (LUMC) demonstrating structural biology research that reveals for the first time a DNA pol IIIC inhibitor, ibezapolstat, bound to its target. The publication is entitled: "A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with LUMC in advancing development of these "new-to-nature" compounds fortifying the foundation for the rational development of this innovative class of antimicrobials against other Gram-positive priority pathogens.In February 2026, we announced that the USPTO granted a new patent for our Pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules.On March 9, 2026 we issued a press release announcing that we are launching a ground-breaking ibezapolstat clinical trial program in patients with recurrent CDI (or rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. When coupled with ibezapolstat ("IBZ") Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezapolstat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI.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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry published in 2020).Acurx's clinical program in the broader CDI patient population is ready to Advance to Phase 3 international pivotal clinical trials. In this regard, we are very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [that is, for registration]'. If formalized, this would end the long-standing two-trial Phase 3 trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial.Full Year and Fourth Quarter and 2025 Financial Results Cash Position:
The Company ended the quarter with cash totaling $7.6 million, compared to $3.7 million as of December 31, 2024. During the fourth quarter, the Company raised a total of approximately $1.5 million of gross proceeds through purchases under the Equity Line of Credit, with gross proceeds of purchases under the Equity Line of Credit totaling approximately $4.0 million for the full year.R&D Expenses:
Research and development expenses for the three months ended December 31, 2025 were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million. The decrease was due primarily to a decrease in manufacturing costs of $0.2 million, and a decrease in consulting costs of $0.3 million as a result of the prior year trial-related expenses. For the twelve months ended December 31, 2025, research & development expenses were $1.8 million versus $5.4 million for the twelve months ended December 31, 2024. The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing costs, and a $1.0 million decrease in consulting costs as prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.G&A Expenses:
General and administrative expenses for the three months ended December 31, 2025 were $1.3 million compared to $2.0 million for the three months ended December 31, 2024, a decrease of $0.7 million. The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees. For the twelve months ended December 31, 2025, general & administrative expenses were $6.3 million versus $8.7 million for the twelve months ended December 31, 2024, a decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees and a $1.4 million decrease in share-based compensation and a $0.4 million decrease in compensation costs, offset by a $0.3 million increase in legal costs.Net Income/Loss:
The Company reported a net loss of $1.6 million or $0.73 per diluted share for the three months ended December 31, 2025 compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8.0 million or $5.32 per diluted share for the twelve months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the twelve months ended December 31, 2024, all for the reasons previously mentioned.The Company had 2,348,113 shares outstanding as of December 31, 2025.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, March 13, 2026Time:8:00 a.m. ETToll free (U.S.):1-877-790-1503; Conference ID: 13758852International:Click here for participant international Toll-Free access numbers
https://www.incommconferencing.com/international-dial-inAbout Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). 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. Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration programIn 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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).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 www.acurxpharma.com. Forward-Looking StatementsAny 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: davidluci@acurxpharma.comACURX PHARMACEUTICALS, INC.
BALANCE SHEETS
AS OF DECEMBER 31, 2025 and 2024

December 31,
December 31,

2025
2024




ASSETS












CURRENT ASSETS





Cash
$7,556,100
$3,706,713Other Receivable

48,417

51,127Prepaid Expenses

85,018

100,123TOTAL ASSETS
$7,689,535
$3,857,963






LIABILITIES AND SHAREHOLDERS' EQUITY












CURRENT LIABILITIES





Accounts Payable and Accrued Expenses
$2,420,943
$3,242,842TOTAL CURRENT LIABILITIES

2,420,943

3,242,842






TOTAL LIABILITIES

2,420,943

3,242,842






COMMITMENTS AND CONTINGENCIES












SHAREHOLDERS' EQUITY





Preferred Stock; $0.001 par value, 10,000,000 shares authorized, no
shares issued and outstanding at December 31, 2025 and 2024

—

—Common Stock; $0.001 par value, 250,000,000 shares authorized,
2,348,113 shares issued and outstanding at December 31, 2025 and
200,000,000 shares authorized, 851,534 shares issued and outstanding
at December 31, 2024

2,348

852Additional Paid-In Capital

80,554,738

67,936,225Accumulated Deficit

(75,288,494)

(67,321,956)






TOTAL SHAREHOLDERS' EQUITY

5,268,592

615,121






TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
$7,689,535
$3,857,963 ACURX PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 2025 AND 2024


Years Ended


December 31,


2025
2024






OPERATING EXPENSES






Research and Development
$1,834,506
$5,403,836
General and Administrative

6,257,477

8,719,391








TOTAL OPERATING EXPENSES

8,091,983

14,123,227








OPERATING LOSS

(8,091,983)

(14,123,227)








OTHER INCOME






Interest Income

125,445

20,124








NET LOSS
$(7,966,538)
$(14,103,103)








LOSS PER SHARE






Basic and diluted net loss per common share
$(5.32)
$(17.45)








Weighted average common shares outstanding, basic and diluted

1,498,793

808,168
 



View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-full-year-and-fourth-quarter-results-and-provides-business-update-302712070.htmlSOURCE Acurx Pharmaceuticals, Inc.

Original: Acurx Pharmaceuticals, Inc. Reports Full Year and Fourth Quarter Results and Provides Business Update

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>>> Acurx Announces New Ibezapolstat Clinical Trial Program in Patients with Recurrent CDI That Has the Potential to Shift the Paradigm of Treatment and Prevention of C. difficile Infection


PR Newswire

March 9, 2026


https://finance.yahoo.com/news/acurx-announces-ibezapolstat-clinical-trial-120100932.html


Acurx's Program in the Broader CDI Patient Population is Ready to Advance to Phase 3 International Clinical Trials

Acurx is launching 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

When coupled with IBZ Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position IBZ as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI

In a Phase 2 trial, all 25 patients treated with IBZ who experienced a clinical cure of CDI were free of recurrence 1 month after treatment and 5 of 5 (100%) of these patients who were observed for 3 months after treatment remained free of recurrence

Recent unpublished data from Dr. Kevin Garey's laboratory at the University of Houston demonstrate that beneficial bacterial taxa persist in fecal samples from patients with rCDI despite multiple prior CDI treatments with the antibiotic standards of care, vancomycin and/or fidaxomicin, indicating that, following acute treatment with IBZ, these beneficial microorganisms will have the opportunity to repopulate the microbiome in a favorable way that may prevent recurrence

Trial start-up activities for this new clinical trial in rCDI will initiate later this month with the first patient expected to enroll in the fourth quarter this year. This open-label trial will enroll up to 20 patients whose CDI has recurred at least twice following standard of care antibiotic treatment within the past 12 months.

Acurx has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA


STATEN ISLAND, N.Y., March 9, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it will conduct a new clinical trial in patients with recurrent C. difficile Infection (rCDI) while its program in the broader CDI patient population is ready to advance to Phase 3 international clinical trials, subject to receiving appropriate funding. 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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).

Results of the above-mentioned experimental data from the University of Houston laboratory of Dr. Kevin Garey, has been submitted in abstract form to the Anaerobe Society of the Americas scientific conference July 7-10, 2026, at Columbia University in New York and will be publicly disclosed shortly thereafter.

More details about this new program will be discussed on the company's March 13, 2026 earnings call for full year and fourth quarter 2025 financial results on Friday, March 13, 2026 at 8:00 am ET (Toll-Free (U.S.): 877-790-1503 Access ID: 13758852). Click here for participant International Toll-Free access numbers. Members of the Acurx R&D team will be available on the earnings call to answer questions from stockholders or other interested parties.

Robert J. DeLuccia, Executive Chairman of Acurx, stated "Ibezapolstat has been demonstrated in Phase 2 to be highly effective in both curing CDI and in preventing recurrence. We believe ibezapolstat has the potential to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI, and such success would shift the paradigm of treatment and prevention of rCDI from two agents to one. This would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the U.S., results in approximately 30,000 deaths, and generates a related public health cost burden of approximately $5 billion, of which $2.8 billion is related to rCDI."

He further stated: "We're also very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [for registration'. If formalized, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. This would of course have favorable effects for our stockholders and, very importantly, CDI patients in need."

For recent publications regarding above, please see our website: www.acurxpharma.com

Makary, NEJM, Feb2026; WK Smits, Nature Communications, Nov2025; Lancet Microbe, June 2025

About rCDI (Recurrent C. difficile Infection)

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.

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

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. 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. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment (10 of 10).

In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. In this Phase 2b trial segment, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT.

When Phase 2b results are combined with Phase 2a results, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated patients) who had Clinical Cure at EOT) (End of Treatment) remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group.

Ibezapolstat was well-tolerated, with no serious adverse events assessed by the blinded investigator to be drug-related. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation in both Clinical Cure and Sustained Clinical Cure.

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection. Furthermore, 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.

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 an 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 Clostridioides difficile Infection

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 20,000 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%.

About the Microbiome in C. difficile Infection 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.) 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 (Garey, 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.

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-positive 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 is Phase 3 ready with plans in progress to begin international clinical trials. 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.

ACXP...............................https://stockcharts.com/sc3/ui/?s=ACXP&p=W&b=5&g=0&id=p86431144783

Acurx Announces New Ibezapolstat Clinical Trial Program in Patients with Recurrent CDI That Has the Potential to Shift the Paradigm of Treatment and Prevention of C. difficile InfectionMarch 9, 2026 8:01 AM
PR Newswire (US)

Acurx's Program in the Broader CDI Patient Population is Ready to Advance to
Phase 3 International Clinical TrialsAcurx is launching 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 oneWhen coupled with IBZ Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position IBZ as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDIIn a Phase 2 trial, all 25 patients treated with IBZ who experienced a clinical cure of CDI were free of recurrence 1 month after treatment and 5 of 5 (100%) of these patients who were observed for 3 months after treatment remained free of recurrenceRecent unpublished data from Dr. Kevin Garey's laboratory at the University of Houston demonstrate that beneficial bacterial taxa persist in fecal samples from patients with rCDI despite multiple prior CDI treatments with the antibiotic standards of care, vancomycin and/or fidaxomicin, indicating that, following acute treatment with IBZ, these beneficial microorganisms will have the opportunity to repopulate the microbiome in a favorable way that may prevent recurrenceTrial start-up activities for this new clinical trial in rCDI will initiate later this month with the first patient expected to enroll in the fourth quarter this year. This open-label trial will enroll up to 20 patients whose CDI has recurred at least twice following standard of care antibiotic treatment within the past 12 months.Acurx has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMASTATEN ISLAND, N.Y., March 9, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it will conduct a new clinical trial in patients with recurrent C. difficile Infection (rCDI) while its program in the broader CDI patient population is ready to advance to Phase 3 international clinical trials, subject to receiving appropriate funding. 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. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).Results of the above-mentioned experimental data from the University of Houston laboratory of Dr. Kevin Garey, has been submitted in abstract form to the Anaerobe Society of the Americas scientific conference July 7-10, 2026, at Columbia University in New York and will be publicly disclosed shortly thereafter.More details about this new program will be discussed on the company's March 13, 2026 earnings call for full year and fourth quarter 2025 financial results on Friday, March 13, 2026 at 8:00 am ET (Toll-Free (U.S.): 877-790-1503  Access ID: 13758852). Click here for participant International Toll-Free access numbers.  Members of the Acurx R&D team will be available on the earnings call to answer questions from stockholders or other interested parties.Robert J. DeLuccia, Executive Chairman of Acurx, stated "Ibezapolstat has been demonstrated in Phase 2 to be highly effective in both curing CDI and in preventing recurrence. We believe ibezapolstat has the potential to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI, and such success would shift the paradigm of treatment and prevention of rCDI from two agents to one. This would be a game changer to the  public health threat that affects approximately 500,000 patients with CDI each year in the U.S., results in approximately 30,000 deaths, and generates a related public health cost burden of approximately $5 billion, of which $2.8 billion is related to rCDI."He further stated: "We're also very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [for registration'. If formalized, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. This would of course have favorable effects for our stockholders and, very importantly, CDI patients in need."For recent publications regarding above, please see our website: www.acurxpharma.com Makary, NEJM, Feb2026; WK Smits, Nature Communications, Nov2025; Lancet Microbe, June 2025 About rCDI (Recurrent C. difficile Infection)
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.Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.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. 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. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment (10 of 10).In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. In this Phase 2b trial segment, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT.When Phase 2b results are combined with Phase 2a results, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated patients) who had Clinical Cure at EOT) (End of Treatment) remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group.Ibezapolstat was well-tolerated, with no serious adverse events assessed by the blinded investigator to be drug-related. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation in both Clinical Cure and Sustained Clinical Cure.In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection. Furthermore, 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.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 an 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 Clostridioides difficile Infection
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 20,000 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%.About the Microbiome in C. difficile Infection 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.) 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 (Garey, 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.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-positive 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 is Phase 3 ready with plans in progress to begin international clinical trials. 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 www.acurxpharma.com. 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, 2024, 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: davidluci@acurxpharma.com



View original content:https://www.prnewswire.com/news-releases/acurx-announces-new-ibezapolstat-clinical-trial-program-in-patients-with-recurrent-cdi-that-has-the-potential-to-shift-the-paradigm-of-treatment-and-prevention-of-c-difficile-infection-302707476.htmlSOURCE Acurx Pharmaceuticals, Inc.

Original: Acurx Announces New Ibezapolstat Clinical Trial Program in Patients with Recurrent CDI That Has the Potential to Shift the Paradigm of Treatment and Prevention of C. difficile Infection

Acurx Pharmaceuticals to Discuss Full Year and Fourth Quarter 2025 Financial Results on March 13, 2026 Conference Call and Provide Business UpdateFebruary 16, 2026 8:01 AM
PR Newswire (US)

STATEN ISLAND, N.Y., Feb. 16, 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 that the Company will discuss its full year and fourth quarter 2025 financial results on Friday, March 13, 2026 at 8:00 am ET before the U.S. financial markets open.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, March 13, 2026  Time:                           8:00 a.m. ET    Toll free (U.S.):           877-790-1503  Access ID: 13758852Click here for participant International Toll-Free access numbers About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). 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 advice for our ibezapolstat pivotal Phase 3 trials. 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 and, if successful, requirements for US NDA submission and EU Marketing Authorization.Acurx previously announced that it had received positive regulatory guidance from EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe.  The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration programIn 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) and drug-resistant Streptococcus pneumoniae (DRSP).To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. 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, 2024, 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: davidluci@acurxpharma.com



View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-to-discuss-full-year-and-fourth-quarter-2025-financial-results-on-march-13-2026-conference-call-and-provide-business-update-302688389.htmlSOURCE Acurx Pharmaceuticals, Inc.

Original: Acurx Pharmaceuticals to Discuss Full Year and Fourth Quarter 2025 Financial Results on March 13, 2026 Conference Call and Provide Business Update

and down the drain it goes

looks like it's all over for this one

i like how they create a fake buy interest and then sell into it.

has this stock just become a scam?

thoughts on the huge sell off anyone?

ACXP strong bottom buster

ACXP bio beast

Company is in great shape to finish Phase 3 with out any dilution. Lock them up tight. Company will be making Billions soon. 

$Acurx Pharmaceuticals Inc Looking pretty thin to $8. News out ACXP commercial tonight during the New to the Street program. Also Investor conference just wrapped up. Slow accumulation last few weeks. Algebra boy keeps calling for 4 dollers and it keeps holding. This is the loading zone!! 

$Acurx Pharmaceuticals Inc The FDA grants "Fast Track Designation" to accelerate the development and review of drugs for serious conditions with an unmet medical need. This designation allows for more frequent meetings with the FDA, rolling submission of the marketing application, and potential eligibility for priority review and accelerated approval. To qualify, a drug candidate must demonstrate the potential to treat a serious condition that has a significant impact on day-to-day functioning or survival, and/or would progress in severity if untreated. Benefits of Fast Track DesignationIncreased FDA Interaction: Enables more frequent and early communication between the developer and the FDA to discuss the product's development plan.Rolling Submission: Allows developers to submit parts of their marketing application on a rolling basis, rather than waiting for the entire application to be completed.Priority Review: May qualify the drug for priority review, which is an expedited review by the FDA.Accelerated Approval: Can make the drug eligible for accelerated approval, allowing for earlier market access based on a surrogate endpoint, with the requirement for confirmatory trials to demonstrate clinical benefit. How to qualifySerious Condition: The drug must target a condition that has a substantial impact on day-to-day functioning or survival, or that would progress in severity if untreated.Unmet Medical Need: There must be no available therapy, or the new treatment must address an unmet need.Submission: The designation can be requested as early as the Investigational New Drug (IND) phase, and the FDA must respond to the request within 60 days.

Extremely Undervalued!! Anything below $8 is a gift at this point. 
Low FloatAnalyst- $31 valuation Global patentsFDA Fasttrack approval antibiotics for Mersa and CDiff Already received favorable status with FDA. ACXP

Buy this Dip!! 

Last Call ACXP up 3.5% on only 133k volume. Spread the word one good push and this is going to rocket. 

If a company were to release a definitive cure for Clostridioides difficile infection (CDI), the impact would be transformative, fundamentally changing healthcare practices and generating immense financial and public health benefits. Paradigm shift in clinical practiceAbolition of recurrence strategies: A true cure would eliminate the need for complex and often unsuccessful strategies to prevent recurrent CDI (rCDI). Current practices include using expensive microbiome-sparing antibiotics like fidaxomicin or performing fecal microbiota transplants (FMT).Changed treatment protocols: The traditional "cycle of infection–reinfection" would be broken. Physicians would no longer be forced into a difficult position where the very antibiotic used to treat the initial CDI episode can also predispose the patient to another infection by destroying protective gut bacteria.Improved patient outcomes: Patients would be spared the prolonged suffering, risk of serious complications like colitis, sepsis, and perforation, and, in severe cases, the risk of death. The psychological and physical toll of this debilitating, often recurring illness would be significantly reduced.Greater antibiotic prescribing freedom: With the threat of CDI minimized, clinicians could feel more confident prescribing broad-spectrum antibiotics when medically necessary, without the constant fear of triggering a CDI episode. 
Major economic shiftsElimination of billions in healthcare costs: Curing CDI would remove an annual financial burden estimated to be over $6 billion in the U.S. alone. The savings would come from:Reduced hospital stays: CDI significantly increases hospital length of stay and intensive care unit admissions.Fewer hospital readmissions: A substantial portion of CDI-related costs comes from readmissions for recurrent infections. One study found that one hospital had a net loss of $2.2 million over four years due to CDI-related hospitalizations.Lower drug and procedure costs: The market for expensive CDI treatments, including new live biotherapeutics and FMT, would shrink dramatically.New market for the "cure" company: The company that develops the cure would gain a massive market. However, the price would have to balance profitability with accessibility, as payers would be incentivized to adopt any cost-effective intervention that eliminates the downstream expenses of CDI treatment.Reprioritization of healthcare funds: The billions of dollars currently spent on CDI treatment could be redirected to other pressing public health needs. 
Operational and public health improvementsSimplified infection control: Hospitals could relax the stringent—and costly—infection control procedures designed to prevent the spread of highly resilient C. difficile spores. This would free up resources and simplify staff workflows.Reduced risk in healthcare settings: With the removal of a major infection risk, hospitals, nursing homes, and other long-term care facilities would become safer for all patients, especially the elderly and immunocompromised.Improved data and surveillance: With CDI largely eradicated, epidemiological focus could shift to other healthcare-associated infections. Data collection and tracking for CDI would become less critical.Boost to the developer's reputation: The company that successfully develops the cure would be seen as a public health hero, gaining enormous goodwill and brand recognition. This could have significant downstream benefits for other products and stock value. Ultimately, a true CDI cure would be a landmark medical achievement, alleviating immense patient suffering and freeing up vast healthcare resources. The long-term effects would be overwhelmingly positive, making it a "holy grail" for infectious disease specialists and public health officials. 

If a company were to release a definitive cure for  infection (CDI), the impact would be transformative, fundamentally changing healthcare practices and generating immense financial and public health benefits. Paradigm shift in clinical practiceMajor economic shiftsOperational and public health improvementsUltimately, a true CDI cure would be a landmark medical achievement, alleviating immense patient suffering and freeing up vast healthcare resources. The long-term effects would be overwhelmingly positive, making it a "holy grail" for infectious disease specialists and public health officials. 

Acurx - >>> 90% Plunge to 1000% Upside? Acurx Pharmaceuticals (ACXP) Stock Sees EMA Boost & Bold Analyst Predictions


Tech Space 2.0

by Marcin Frackiewicz

8 October 2025


https://ts2.tech/en/90-plunge-to-1000-upside-acurx-pharmaceuticals-acxp-stock-sees-ema-boost-bold-analyst-predictions/


Stock Price Collapse: Acurx Pharmaceuticals (NASDAQ: ACXP) trades around $4.3 per share (post-reverse-split) as of early October 2025 – down roughly 90% from its 52-week high of $44 [1]. The company executed a 1-for-20 reverse stock split in August to regain Nasdaq listing compliance [2].

Recent Rally on EMA News: Shares ticked up in late September after the European Medicines Agency (EMA)gave a positive opinion on Acurx’s Pediatric Investigation Plan (PIP) for its lead antibiotic, ibezapolstat [3]. This regulatory green light is a key step toward Phase 3 trials and future European approval.

Analysts See Huge Upside: Despite the stock’s collapse, Wall Street remains extraordinarily bullish. H.C. Wainwright reiterated a Buy rating with a $31 price target, versus ~$4 current – and analyst targets range from $20 up to $165.80 [4]. The average 12-month target (~$30–$60) implies +500% to +1300% upside if Acurx delivers on its drug pipeline.

Clinical-Stage Antibiotic Developer: Acurx is a late-stage biotech developing a new class of narrow-spectrum antibiotics for tough infections. Its lead candidate ibezapolstat (for C. difficile infections) is Phase 3–ready with FDA Fast Track and QIDP designations. Acurx’s preclinical pipeline (e.g. ACX-375C) targets other Gram-positive pathogens like MRSA, VRE, and even anthrax [5] [6].

Financials & Cash Runway: The company is pre-revenue and reported a net loss of ~$2.2M in Q2 2025. It ended Q2 with $6.1?million in cash on hand [7] after small financings, enough for near-term operations but additional funding will be needed to launch costly Phase 3 trials. In Q3, shareholders approved increasing authorized shares to 250 million, signaling potential future equity raises [8].

Investor Outreach & Alerts: To drum up investor interest, Acurx renewed a media partnership with New to The Street, featuring televised CEO interviews, national TV commercials, and online campaigns to spotlight Acurx’s story [9] [10]. The company also announced it regained full Nasdaq compliance in September (meeting minimum price and equity requirements) – critical to maintain its listing [11].

Current News & October 2025 Updates

EMA Positive Opinion: A major recent catalyst for Acurx came on September 30, 2025, when the EMA’s Paediatric Committee issued a positive opinion on the Pediatric Investigation Plan (PIP) for Acurx’s lead drug, ibezapolstat, in Clostridioides difficile infection [12]. This essentially means European regulators agree with Acurx’s plan to study ibezapolstat in children, a prerequisite for future marketing approval in Europe. As the company noted, the PIP approval “ensur[es] necessary data are obtained to support the drug’s authorization and use in pediatric populations.” [13] This news helped lift ACXP stock from about $4.18 to $4.60 at the end of that week [14], reflecting investor optimism about Acurx’s regulatory momentum.

Regained Nasdaq Compliance: In early October, Acurx confirmed it had regained full compliance with Nasdaq’s listing rules after its reverse split and financial moves. The company now meets both the minimum $1.00 bid price and shareholders’ equity requirements, so its stock will remain listed on the Nasdaq Capital Market [15]. This removes an overhang of delisting risk that had been pressuring the stock. Acurx’s Board had pushed through a 1-for-20 reverse split effective August 5, 2025 specifically to boost the share price above $1 [16]. The split shrank outstanding shares from ~30.7 million to ~1.54 million [17] and lifted the stock from mere pennies to a few dollars overnight. While such reverse splits often signal distress, in Acurx’s case it successfully preserved the Nasdaq listing – a key positive for investor confidence.

Share Authorization Increase: Additionally, shareholders approved an increase in authorized common shares from 200 million to 250 million (post-split) at a special meeting [18]. This move, along with an equity line of creditestablished with Lincoln Park Capital for up to $12 million [19] [20], positions Acurx to raise capital as needed. Investors should note this could lead to future dilution if/when the company issues new shares to fund its Phase 3 trials. Acurx’s management has explicitly adopted a “multi-step approach” to financing – combining traditional offerings, warrant inducement deals, and potential public-private partnerships – to secure the funding required [21].

Media & Investor Outreach: On the publicity front, Acurx has been actively courting investors and visibility. In April 2025 the company renewed a 6-month media campaign with New to The Street, a financial news TV program, and in September it extended this partnership [22]. The expanded agreement includes long-form interviews airing on Fox Business and Bloomberg TV, over 300 national TV commercials, and “accredited investor” conference events to showcase Acurx [23] [24]. “We’re excited to expand our media footprint… [New to The Street’s] platform helps us communicate our mission to bring novel, life-saving antibiotics to market to millions,” said Acurx CEO David Luci [25]. This aggressive outreach is somewhat unusual for a biotech of Acurx’s size, and indicates the company’s urgency in attracting investor interest (likely ahead of major trial milestones and fundraising).

Q3 Developments Outlook: As of October 8, 2025, no new material events have been reported beyond the EMA pediatric plan news. Investors are now looking ahead to Phase 3 trial initiation for ibezapolstat. Acurx has indicated it is “well positioned to commence [the] international Phase 3 program” for ibezapolstat, with plans for two global trials vs. standard-of-care vancomycin [26] [27]. The exact start timing depends on securing sufficient financing. Any announcements of partnerships, grant funding (e.g. CARB-X or BARDA for antibiotics, or a capital raise will be closely watched as potential catalysts or risks in late 2025.

Stock Price & Recent Movement

Acurx’s share price tells a tale of extreme volatility and risk. After going public in mid-2021, ACXP traded in the $20–$40 range (split-adjusted) for a time, but 2022–2024 saw a severe slide. The stock hit a 52-week high of $44 in October 2024 but then collapsed to a low of ~$3.80 by August 2025 [28]. This ~90% nosedive was driven by a mix of dilution, financing worries, and lack of near-term revenue as the company’s antibiotic program advanced slowly.

Following the Aug 2025 reverse split, ACXP shares fluctuated mostly between $4 and $5. In late September, the EMA news gave a short-lived boost – closing $4.60 on Oct 1, 2025 [29] – though profit-taking and market volatility saw it drift back to ~$4.3 by Oct 8. Trading volume is relatively low (often only 30–100K shares per day [30]), reflecting its micro-cap status. This means the stock can swing sharply on any news or trading imbalances. For example, on some days in Q3 the stock moved 10–20% intraday on no news, a reminder of its high volatility (recent 11% weekly volatility, higher than 75% of U.S. stocks [31]).

It’s important to note that Acurx’s market capitalization is only around $6–7 million at the current share price [32]. Such a low valuation partly prices in the significant risks (discussed below) but also means even small absolute changes in price equal large percentage moves. For context, at ~$4.30 per share, the entire company’s market cap is less than the cost of running a Phase 3 trial – an indicator of market skepticism. On the flip side, this tiny float sets the stage for outsized gains if Acurx delivers positive outcomes. The stock’s year-to-date total return lags far behind the S&P 500 (which is up ~12% YTD) after ACXP’s decline [33], but any clinical breakthroughs could quickly reverse that trend.

Investors should be prepared for continued high volatility. The stock’s 52-week range is $3.80 – $44.00 [34], and even after the reverse split, ACXP remains a “penny stock” in disguise. Only risk-tolerant investors should consider small biotech stocks like Acurx, and even then, position sizing and diversification are key due to the binary nature of drug trial outcomes.

(For a visualization, the chart below shows ACXP’s dramatic price drop over the past year, then stabilizing around the $4 level after the August 2025 reverse split.)

Figure: ACXP share price over the past 12 months (adjusted for 1:20 split), highlighting the steep decline from late 2024 into 2025 and recent stabilization. Source: INDmoney/Company IR data. [35] [36]

Analyst Forecasts and Expert Analysis

Despite Acurx’s challenges, the few analysts covering the stock are incredibly bullish – arguably reflecting the huge opportunity if ibezapolstat succeeds, as well as the low base valuation. According to TipRanks, two Wall Street analystshave published targets in the past 3 months with an average price target of $30.50 (range $30 to $31) – representing +570% upside from the ~$4.55 share price in early October [37]. The consensus rating is a “Moderate Buy / Strong Buy” [38]. Similarly, H.C. Wainwright & Co. (Acurx’s most active analyst) reiterated its Buy rating on October 1, 2025, citing the positive EMA news. H.C.W. maintains a $31 target for ACXP and emphasized this is a “significant upside from the current price of $4.29” [39]. In fact, investing.com data shows analyst targets ranging from $20 on the low end to a stunning $165.80 on the high end [40]. Even the low-end $20 target implies nearly a 5× increase, while the high end suggests a speculative scenario of ~40× upside. Such sky-high targets indicate that if Acurx’s Phase 3 trial succeeds and its antibiotic reaches the market, the company’s value could dramatically rerate closer to peers (i.e. hundreds of millions in market cap).

Why are analysts so optimistic? A key reason is the unmet medical need and market potential for a new C. difficileantibiotic. C. difficile infections (CDI) cause ~500,000 illnesses and tens of thousands of deaths annually (per CDC) and are classified as an “urgent threat” due to rising antibiotic resistance [41]. Vancomycin and fidaxomicin are current treatments, but recurrence rates are high and new mechanisms are needed. Ibezapolstat’s novel targeting of bacterial DNA polymerase IIIC could make it a first-in-class treatment for CDI. Furthermore, ibezapolstat’s narrow-spectrum profile aims to kill C. diff while sparing healthy gut bacteria [42] [43], potentially reducing the collateral damage that leads to recurrent infections. This differentiated profile suggests that if Phase 3 confirms safety/efficacy, ibezapolstat could capture significant usage, especially as antibiotic stewardship programs favor narrow-spectrum agents.

Analysts also point to Acurx’s regulatory designations that could accelerate or enhance the drug’s value: the FDA granted ibezapolstat Fast Track status and Qualified Infectious Disease Product (QIDP) designation (which confers 5 extra years of market exclusivity if approved) [44]. These are strong signals about the drug’s importance. The recent EMA feedback (Scientific Advice and PIP approval) means both U.S. and European regulators are essentially on the same page regarding Acurx’s Phase 3 plans [45] [46]. This de-risks the clinical program to some extent, as Acurx has clarity on trial design and endpoints needed for approval.

However, it’s worth noting a disconnect: while analysts issue high targets, the market’s actual sentiment is cautious – evidenced by the low $6M valuation. This likely reflects concerns that analysts themselves acknowledge in fine print: financing risk and execution risk. Acurx’s cash is limited, and raising significant capital (say $20–$30M or more) could dilute current shareholders heavily, which isn’t always fully baked into price targets. Additionally, until Phase 3 data arrives (likely 2026 at earliest), the stock could remain subdued.

Expert investor commentary tends to be mixed. Some biotech commentators note that antibiotic developers face a notoriously tough market – even an approved drug can struggle commercially without government support, as new antibiotics are often held in reserve (to avoid resistance) and not big money-makers. For instance, the collapse or sale of peers like Paratek Pharmaceuticals (maker of Nuzyra) and Melinta have made investors skeptical of small antibiotic biotechs. This likely contributes to Acurx’s low valuation. Bulls counter that C. difficile is a high-value niche (hospitals desperately need better CDI therapies), and Acurx’s small size could actually make it an attractive takeover target if Phase 3 succeeds. The recent $8.0B acquisition of Merus (for an antibody, not an antibiotic) shows big pharma will pay up for needed therapeutics [47] – though antibiotics have historically seen fewer big buyouts.

In summary, analysts “strongly buy” ACXP for its high reward potential, but the market is in “wait-and-see” mode. Investors should carefully weigh the 1000% upside scenarios vs. the very real possibility of further dilution or setbacks. Independent biotech reviewers advise that Acurx’s stock is essentially an all-or-nothing bet on ibezapolstat’s Phase 3. Any positive interim data or partnerships could ignite the stock, while a trial failure would be devastating. Thus, while ACXP offers a speculative opportunity, it is not for the faint of heart.

Business Overview & Clinical Pipeline

Acurx Pharmaceuticals is a clinical-stage biopharmaceutical company founded in 2017 and headquartered in Staten Island, NY, focused on developing novel antibiotics for difficult-to-treat bacterial infections [48] [49]. Unlike broad-spectrum antibiotics that wipe out good and bad bacteria alike, Acurx is pioneering a Gram-Positive Selective Spectrum (GPSS®) approach [50]. All of its drug candidates work by blocking the bacterial enzyme DNA polymerase IIIC (pol IIIC), an enzyme found in many Gram-positive pathogens but not in Gram-negative bacteria [51] [52]. In theory, this yields antibiotics that kill targeted superbugs (like C. diff or MRSA) without harming the beneficial flora in our bodies.

The company’s pipeline is outlined below:

Drug Candidate Target Indication Stage Notes/Status

Ibezapolstat C. difficileInfection (CDI) – initial treatment Phase 3–ready

Oral small-molecule antibiotic. Novel pol IIIC inhibitor. Successfully completed Phase 2b; received FDA Fast Track and QIDP designations [53]. International Phase 3 trials planned (2 studies vs. vancomycin) pending funding [54] [55]. Pediatric study plan approved by EMA [56].
ACX-375C(GPSS class) Gram-positive infections: MRSA, VRE, DRSP, Anthrax Preclinical (Lead) New GPSS antibiotic for drug-resistant skin and bloodstream infections(ABSSSI, etc.) [57]. Indian patent granted (expires 2039) [58]. Also eyed for inhaled anthrax treatment in biodefense [59]. Advanced lead optimization; poised for IND-enabling studies.

Other GPSS pipeline Additional DNA pol IIIC inhibitor variants Discovery

Acurx is exploring other analogues/backup compounds targeting Gram-positive “superbugs.” The focus is on oral formulations that address unmet needs in serious infections. Publications and mechanistic studies (e.g. with Leiden University) are ongoing [60] [61].

Table: Acurx Pharmaceuticals Pipeline – Lead drug ibezapolstat for C. diff is approaching Phase 3. ACX-375C is a follow-on preclinical candidate targeting MRSA and other resistant bacteria, with a long patent life and potential anthrax application. GPSS = Gram-Positive Selective Spectrum.

Ibezapolstat – the crown jewel of Acurx’s pipeline – completed a Phase 2 trial in 2021–22, demonstrating promising clinical cure rates for C. difficile infection with what Acurx called a “sparing” effect on the gut microbiome. Notably, the Phase 2b results were published in The Lancet Microbe in June 2025 [62], a respected peer-reviewed journal, which adds credibility to the program. The mechanism of action research presented in 2025 showed ibezapolstat binds a unique site on DNA pol IIIC not present in human cells, explaining its targeted bacterial kill effect [63]. With Phase 2 data in hand, Acurx has been preparing for Phase 3: the design involves two identically designed multinational trials, each comparing ibezapolstat to standard vancomycin in adult CDI patients, aiming to show non-inferiority (or superiority) in cure rates and lower recurrence [64]. Thanks to prior FDA discussions and the recent EMA advice, Acurx has finalized key details (sample size, endpoints, statistical analysis plan) for these trials [65]. The only barrier is funding – management has openly stated that launching Phase 3 is “subject to obtaining appropriate financing” [66].

If ibezapolstat’s Phase 3 is successful, Acurx could file for FDA approval, possibly bringing the first new class of antibiotic for C. diff to market in decades. The Fast Track status might enable a rolling submission and priority review. Moreover, as a QIDP under the GAIN Act, ibezapolstat would enjoy up to 10 years of U.S. market exclusivity upon approval (5 years standard + 5 years QIDP extension) [67] – a critical advantage given how quickly generic competition can erode drug profits.

Beyond ibezapolstat, ACX-375C represents Acurx’s attempt to expand its platform to other deadly pathogens. ACX-375C (likely named after the chemistry scaffold) is being developed for infections like MRSA (methicillin-resistant Staph aureus) and VRE (vancomycin-resistant Enterococcus), which are leading causes of hospital-acquired infections. Acurx reported that ACX-375C’s patent coverage was strengthened in 2025, and it’s targeting organisms on the CDC’s high priority list (including S. pneumoniae and B. anthracis) [68]. Interestingly, Acurx hinted at a dual-use for ACX-375C: an orally dosed version for skin infections (like MRSA abscesses) and an inhaled formulation for anthraxas a biodefense countermeasure [69]. This is still early-stage, but if ACX-375C shows potent broad activity against Gram-positive biothreats, Acurx could seek non-dilutive funding (government grants or contracts) given renewed interest in antibiotic stockpiles.

In summary, Acurx’s business strategy is to build a pipeline of niche, targeted antibiotics at a time when large pharmaceutical companies have mostly abandoned antibiotic R&D. The company’s GPSS platform is fairly unique – by zeroing in on pol IIIC in Gram-positives, they aim to circumvent cross-resistance with existing drugs and minimize microbiome disruption. However, the commercial success of such drugs will depend on how hospitals use them (e.g. first-line vs. reserved). Acurx may eventually need a larger partner to help commercialize ibezapolstat globally, as marketing an antibiotic to hospitals can be resource-intensive. For now, the company remains focused on clinical execution: getting ibezapolstat through Phase 3 and expanding the preclinical pipeline enough to attract partnerships or grants.

FDA & Regulatory Status

Regulatory support has been one of Acurx’s bright spots. On top of the EMA PIP approval discussed earlier, Acurx has benefited from several FDA programs meant to encourage antibiotic development:

QIDP Designation: The FDA granted Qualified Infectious Disease Product status to ibezapolstat for CDI back in 2018 [70]. This designation, under the GAIN Act, is reserved for anti-infectives tackling serious or resistant pathogens. It provides incentives like priority review and an extra 5-year exclusivity if the drug is approved – effectively extending the proprietary life of ibezapolstat, which could be a major commercial benefit in the antibiotic market (where sales ramp slowly). QIDP status also signals that regulators recognize the drug’s importance in addressing an urgent public health threat.

Fast Track Designation: In 2019, ibezapolstat received Fast Track from the FDA [71]. Fast Track helps expedite the development and review process, enabling more frequent FDA interactions and potential rolling submission of a New Drug Application (NDA). This should smooth the path as Acurx heads into Phase 3, allowing them to incorporate FDA feedback early and potentially get priority review (6-month review time) for the NDA.

Scientific Advice from EMA: Parallel to FDA guidance, Acurx sought Scientific Advice from the EMA(Europe’s regulator) in 2023–2024 to ensure its Phase 3 trial design would satisfy European requirements. In July 2025, Acurx announced the EMA had provided positive feedback – essentially confirming that the planned Phase 3 program (two trials, endpoints, analysis plan) is acceptable for a future Marketing Authorization Application in Europe [72]. This coordination between FDA and EMA feedback is valuable; it means Acurx can run one set of trials to serve both U.S. and EU approvals, saving time and money.

Pediatric Plan Approval: As noted, the EMA’s recent approval of the Pediatric Investigation Plan is another box checked. Antibiotics intended for broad use typically need to assess safety in pediatric populations. With the PIP agreed, Acurx can proceed with including pediatric considerations in or alongside Phase 3. It’s an early move, but it prevents delays later on – and it underscores that regulators see a potential use for ibezapolstat in children (where C. diff can be very serious). The EMA decision “caps off the requirement to have the PIP agreed to by the initiation of Phase 3” [73], clearing the last regulatory pre-condition for starting the trial in the EU.

Looking ahead, Acurx will likely seek FDA End-of-Phase-2 meetings (if not done already) to nail down any final trial details. Given the alignment with EMA and the prior design discussions, no major hurdles are expected from a regulatory perspective. The key risks now lie in execution – i.e., enrolling the trials, demonstrating that ibezapolstat is at least non-inferior to vancomycin in curing C. diff, and preferably showing a lower recurrence rate (which would be a game-changer in CDI treatment).

One regulatory nuance: Because C. diff infection can be life-threatening, FDA could potentially allow an early stop for efficacy if ibezapolstat shows overwhelmingly positive results, or consider adaptive trial designs. However, non-inferiority trials typically must fully enroll to accurately compare outcomes. Investors should expect the Phase 3 program to take 12–18 months once started, meaning top-line data might come in 2026. Any interim updates (like DSMB safety reviews or enrollment progress) could affect the stock in the interim.

Overall, Acurx has skillfully leveraged regulatory programs to de-risk and speed up its antibiotic development. The real test will be meeting those regulators’ efficacy standards in Phase 3. If it does, the prior Fast Track and QIDP will kick in to help expedite getting ibezapolstat to the patients who need it.

Financial Position and Investor Alerts

Cash Burn & Q2 Results: Acurx remains a pre-revenue biotech, so its financial health depends on managing expenses and raising capital. In the second quarter of 2025, Acurx reported a net loss of $2.2 million (or -$1.89 per share) [74]. R&D spending was only ~$0.5M for Q2 (down from $1.8M in Q2 2024) [75], reflecting that the company had paused expensive late-stage trials while seeking funds. General admin costs have also been kept lean (under $1M/quarter). As of June 30, 2025, Acurx had $6.1 million in cash on the balance sheet [76] – thanks to a series of small financings in the first half. Specifically, in H1 2025 the company raised $3.4M gross via an Equity Line of Credit and warrant exercises [77]. Earlier, in March 2025, Acurx did a $1.1M direct offering of shares/warrants [78], and in June it induced warrant holders to exercise at a discounted price (netting ~$2.5M) [79]. These moves diluted shareholders (bringing total shares to ~30.7M pre-split) but were necessary to extend the cash runway.

At the current burn rate, $6.1M would last perhaps through Q4 2025. But to initiate Phase 3, Acurx will need a much larger capital infusion – likely $10–20+ million. Management has indicated it will continue tapping the Lincoln Park equity line (which allows periodic stock sales into the market) and pursue “public-private partnerships.” One hope is to get funding from government or non-profits focused on antibiotics (for example, CARB-X grants or Biomedical Advanced Research and Development Authority (BARDA) contracts for anthrax work). Any such non-dilutive funding would be a welcome surprise for investors.

Balance Sheet and Capital Structure: After the 1-for-20 reverse split, Acurx has approximately 1.54 million shares outstanding [80]. The float is relatively tight, but the shelf of authorized shares is now 250M, giving plenty of room to issue new equity. There are also a significant number of warrants outstanding (from prior offerings) – for instance, the June inducement created new G-1 and G-2 warrants (exercise prices $8.50 post-split) totaling ~444,543 shares worth, which are long-term five-year warrants [81]. These won’t convert unless the stock rises well above $8.50, but if it does, Acurx could get an additional ~$3.8M cash from those exercises. In short, dilution is an ongoing concern: current shareholders’ stakes could be heavily diluted if the company issues, say, 5 million new shares to raise capital (tripling the share count). On the flip side, if funding is secured in a shareholder-friendly way (strategic partnership, milestone-based funding, etc.), it could greatly enhance Acurx’s stability.

Investors should also be aware that micro-cap stocks like ACXP are sometimes subject to retail trading promotion or volatility. The company’s engagement of New to The Street (a paid media outlet) is a form of promotion, though fully disclosed. There is no indication of any improper activity, but as always one should be cautious of overhyping. So far, no major investor lawsuits or SEC actions are known for Acurx – it appears to be operating by the book. In fact, the Law Offices of Howard G. Smith investor alert often seen after big drops was for AcelRx (a different pharma), not Acurx [82].

One potential investor “alert” item: in mid-2025 Acurx had to regain Nasdaq compliance not just on price but also on stockholders’ equity – Nasdaq requires a minimum of $2.5M in equity for continued listing. By increasing authorized shares and raising cash, Acurx was able to push its equity above that threshold (likely aided by the warrant exercises and the Lincoln Park deal). As of the special meeting, the company has satisfied Nasdaq that it’s above the required equity minimum [83]. This removed the immediate threat of a delisting notice on that basis.

In summary, Acurx’s financial situation is tight but navigable in the short term. The company will be in fundraising mode through 2025. Investors should keep an eye on any announcements of new stock offerings or partnerships, as these can significantly impact the stock. A dilutive offering at a discount could pressure the share price further, while a non-dilutive funding or major partnership (e.g. licensing ibezapolstat ex-US) could instantly add value and reduce financing risk. Given ACXP’s low market cap, even financing news can swing the price dramatically.

Comparison with Peer Companies

To put Acurx’s prospects in perspective, it helps to compare it with some similar small pharmaceutical companies, especially those in the antibiotic/anti-infective space:

Spero Therapeutics (NASDAQ: SPRO): Spero is a biotech that, like Acurx, works on novel antibacterials. Spero recently reported success in a Phase 3 trial for an oral antibiotic (tebipenem for UTIs) in partnership with GSK. As a result, Spero’s stock surged and it now commands a market cap around $100 million [84] [85] – still small, but far above Acurx’s ~$6M. This gap underscores Acurx’s deep undervaluation if its drug works. However, Spero’s case also shows the necessity of a big partner(GSK) and a clear path to market to unlock value. Acurx might similarly seek a partnership once Phase 3 data is in sight.

Summit Therapeutics (NASDAQ: SMMT): Summit actually developed a competitor CDI antibiotic (ridinilazole) that unfortunately failed Phase 3 in 2022, unable to beat vancomycin. Summit’s stock collapsed and it pivoted to oncology; its antibiotic program was shelved. This cautionary tale highlights the risk in C. diff trials – positive Phase 2 data doesn’t guarantee Phase 3 success. Summit’s market cap, after a wild ride due to its new oncology deal, is around $200M. But the antibiotic failure alone likely would have valued it near Acurx’s range. The lesson for Acurx: design Phase 3 robustly and try to demonstrate not just non-inferiority but an improvement in recurrence, which ridinilazole failed to show. Encouragingly, Acurx’s Phase 2b hinted at low recurrence, but Phase 3 will be the true test.

Seres Therapeutics (NASDAQ: MCRB) and Ferring Pharmaceuticals: These companies took a microbiome therapy approach to C. diff. Seres’ oral microbiome pill (VE303) for preventing recurrent C. diff infection succeeded in trials and got FDA approved (branded Vowst in 2023). Seres (market cap ~$300M) proves there is commercial interest in better CDI treatments. However, microbiome therapies like Vowst are for recurrentinfection, whereas Acurx’s antibiotic is for initial treatment. In the future, these could be complementary – ibezapolstat to cure the infection, followed by a microbiome therapeutic to restore gut flora and prevent recurrence. The competitive takeaway is that Acurx is not alone in targeting CDI, but it is unique in using a traditional antibiotic modality with a twist (narrow spectrum). If ibezapolstat works, it could potentially displace vancomycin or fidaxomicin as first-line therapy, with microbiome therapies as follow-up.

Other Antibiotic Micro-Caps: Acurx is among a handful of tiny antibiotic developers still afloat. Scynexis (NASDAQ: SCYX), though focused on antifungals, recently licensed its approved drug and trades around a $30M market cap. Iterum Therapeutics (NASDAQ: ITRM), another micro-cap, had a failed FDA attempt for a UTI antibiotic and now trades as essentially a penny stock. Cidara (NASDAQ: CDTX) pivoted to antivirals after antifungal approval; Nabriva (NASDAQ: NBRV) and Melinta went bankrupt/ reorganized. The trend is clear: it’s a tough road. Acurx stands out by virtue of still being in late-stage development with a Phase 3-ready asset – many peers either succeeded and got acquired or failed and folded. This binary nature means Acurx could either join the success stories (and see its valuation jump multi-fold) or struggle like those that didn’t make it.

One encouraging sign for Acurx is growing public sector support for antibiotics. In 2022, the PASTEUR Act (which would create a subscription payment model for novel antibiotics) was proposed in the U.S. If such policies advance by the time ibezapolstat hits the market, companies like Acurx could receive government payments or rewards for approval, making the business more attractive. Investors in ACXP might not be pricing in this possibility, so any progress on antibiotic incentives could positively re-rate the entire sector.

In conclusion, compared to peers, Acurx is exceptionally high-risk/high-reward. Its valuation is lowest-of-the-low right now, reflecting doubt that it can follow through. But the flip side is that even partial success could make ACXP a multi-bagger to catch up with peers like Spero or beyond. It’s crucial that management executes Phase 3 efficiently and seeks creative ways to finance it. Collaboration with a larger pharma or securing grants would not only validate Acurx’s science but also help it break out from the pack of struggling micro-cap biotechs.

Conclusion and Outlook

Acurx Pharmaceuticals presents a classic biotech conundrum for investors: a tiny company with a promising drug candidate in a critical area of unmet need, yet weighed down by financial strain and market skepticism. The next 12–18 months will likely determine its fate. On one hand, Acurx has a lot going for it now: a clear regulatory runway (FDA & EMA support), Phase 2 proof-of-concept published in a top journal, and enthusiastic analyst support envisioning a potential ten-bagger stock scenario [86]. The recent EMA pediatric plan approval adds to the momentum, showing that global regulators are effectively giving Acurx a thumbs-up to proceed.

On the other hand, the company faces the harsh realities common to antibiotic startups. It must secure significant capital in a risk-averse market to fund Phase 3 trials, and it operates in a field where even approved products can struggle commercially. The stock’s 90% plunge over the past year [87] reflects those concerns, but also perhaps an overreaction now that key uncertainties (like Nasdaq listing) have been resolved. For existing shareholders, the dilution so far has been painful – yet if Acurx can make it to the finish line and prove ibezapolstat’s worth, today’s low share price could, in hindsight, look like a bargain.

Near-term catalysts to watch: Any financing or partnership announcements (which could swing the stock either way), the official start of Phase 3 enrollment, and interim updates on that trial. Additionally, Acurx’s presence in media (through New to The Street interviews, etc.) may generate trading buzz, though ultimately fundamental news will drive sustained gains. Investors should also monitor competitor developments – for instance, if another CDI therapy enters Phase 3 or if policymakers advance antibiotic incentives, as these external factors can influence sentiment on ACXP.

In summary, Acurx Pharmaceuticals is at a pivotal crossroads. It offers a high-risk “lottery ticket” on a much-needed medical breakthrough, paired with the downside risk of further dilution or trial failure. The clickbait headline of a 1000% upside is not just hype – it’s rooted in real analyst models assuming success. But prudent investors will weigh that against the very tangible hurdles ahead. As of October 2025, the company has bought itself time and opportunity: a fresh regulatory go-ahead, a Nasdaq listing intact, and a plan to reach the goal line. Now, Acurx must execute and earnthe market’s confidence. For those bullish on its mission to conquer C. diff, the next year will be crucial to see if ACXP can start to fulfill the bold expectations – or become another cautionary tale in the antibiotic arena.

Sources: Recent press releases and financial filings, EMA/FDA communications, Investing.com analysis [88] [89], company investor presentations, and industry reports have been referenced throughout this report to ensure accuracy and timeliness of information.

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Acurx Pharmaceuticals has a consensus Moderate Buy rating with an
average price target of $30.50, suggesting a potential 610.96% upside.

$15 target

ACXP........................................................https://stockcharts.com/h-sc/ui?s=ACXP&p=W&b=5&g=0&id=p86431144783

$11.00 pre-market a site for sleepy eyes!🥰

Still going $8s..