ACXP Acurx Pharmaceuticals Inc.

5.68
+0.1  (+2%)
Previous Close 5.58
Open 5.58
52 Week Low 5.03
52 Week High 8.74
Market Cap $56,323,783
Shares 9,916,159
Float 7,610,981
Enterprise Value $53,762,013
Volume 113,285
Av. Daily Volume 0
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Drug Pipeline

Drug Stage Notes
Ibezapolstat
C. difficile Infection
Phase 2b
Phase 2b
Phase 2b trial to commence early 2022.

Latest News

  1. STATEN ISLAND, N.Y., July 28, 2021 /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, announced today that the Company will release its 2021 second quarter financial results on Tuesday, August 17, 2021, at 8:30 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: Tuesday, August 17, 2021
    Time: 8:30 a.m. ET
    Toll free (U.S. and International): 877-790-1503
    Conference ID: 13721752

    About Ibezapolstat

    STATEN ISLAND, N.Y., July 28, 2021 /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, announced today that the Company will release its 2021 second quarter financial results on Tuesday, August 17, 2021, at 8:30 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: Tuesday, August 17, 2021

    Time: 8:30 a.m. ET

    Toll free (U.S. and International): 877-790-1503

    Conference ID: 13721752

    About Ibezapolstat

    Ibezapolstat is a novel, orally-administered antibacterial compound being developed as a targeted, narrow spectrum oral antibiotic for the treatment of patients with C. difficile Infection (CDI). It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

    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 Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat and in the second half of 2021 Acurx expects to begin enrollment of its Phase 2b vancomycin-controlled efficacy study in a 1:1 randomized trial of a total of 64 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 clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D preclinical pipeline includes antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Penicillin-Resistant Streptococcus pneumoniae (PRSP).

    To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.

    Investor Contact:

    Acurx Pharmaceuticals, Inc.

    David P. Luci, President & CEO

    Tel: 917-533-1469

    Email: 

    Cision View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-to-discuss-2021-second-quarter-financial-results-on-august-17-2021-conference-call-and-provide-business-update-301342371.html

    SOURCE Acurx Pharmaceuticals, Inc.

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  2. STATEN ISLAND, N.Y., July 7, 2021 /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, announced today that it has filed a provisional patent application in the United States Patent and Trademark Office (USPTO). The filing of this patent application relates to ibezapolstat and its use to treat C. difficile Infection while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. This is the latest in the series of patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials. Acurx is commencing a Phase…

    STATEN ISLAND, N.Y., July 7, 2021 /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, announced today that it has filed a provisional patent application in the United States Patent and Trademark Office (USPTO). The filing of this patent application relates to ibezapolstat and its use to treat C. difficile Infection while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. This is the latest in the series of patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials. Acurx is commencing a Phase 2b clinical trial in patients with CDI (Clostridioides difficile Infection) during the second half of this year after having recently completed a Ph2a clinical trial which demonstrated that 10 of 10 patients with CDI (100%) met the study's primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure with no recurrence of CDI at the 28-day follow-up visit.

    Acurx continues to pursue protection for its technologies in the United States and internationally. Acurx aims to protect the technology, inventions, know-how, and improvements that are important to the development of its business using the most effective intellectual property instruments.

    Robert J. DeLuccia, Executive Chairman of Acurx, stated "We believe that ibezapolstat's Gram-Positive Selective Spectrum (GPSS™), kills C. difficile, but not other Firmicutes necessary for maintaining a healthy microbiome, and it spares the important Actinobacteria phylum needed for maintaining a healthy microbiome." He further stated: "This concept of a dual-effect treatment which includes bactericidal activity against C. difficile bacteria while at the same time providing a restorative effect on the microbiome has the potential to position ibezapolstat as an important first-line therapy for CDI."

    David P. Luci, President & CEO of Acurx, stated: "We believe ibezapolstat's dual effect to effectively treat patients with CDI while simultaneously and dramatically reducing the likelihood of recurrence by restoring the microbiome would be a significant therapeutic advance. This dual effect would substantially reduce CDI recurrences and if this trend continues in later-stage clinical trials, and ibezapolstat is ultimately approved, it could have a dramatically positive impact on patient outcomes and on reducing downstream healthcare costs." 

    About Clostridioides difficile Infection (CDI). 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, et al, 2015, New England Journal of Medicine). 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, New England Journal of Medicine). Based on internal estimates, the recurrence rate of two of the three 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 Clostridioides difficile Infection (CDI)

    C. difficile can sometimes be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

    About the Ibezapolstat Phase 2 Clinical Trial.

    The multicenter, open-label single-arm segment of this study is to be followed by a double-blind, randomized, active-controlled segment comprise the Phase 2 clinical trial designed to evaluate ibezapolstat in the treatment of CDI. Segment 2a of this trial was an open-label cohort of up to 20 subjects from study centers in the United States. In this cohort, all 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, the Trial Oversight Committee assessed the safety and tolerability and made recommendation regarding study continuation.  Based on the recommendation of Acurx's Scientific Advisory Board (SAB), we terminated enrollment in Phase 2a early and are now advancing to Phase 2b. The SAB unanimously supported the early termination of the Phase 2a trial after 10 patients were enrolled in the trial instead of 20 patients as originally planned. The early termination was further based on the evidence of meeting the treatment goals of eliminating the infection (100%), with no recurrences of infection, and with an acceptable adverse event profile. In Segment 2b, approximately 64 additional patients with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments will be identical in appearance, dosing times, and number of capsules administered to maintain the blind.

    About Acurx Pharmaceuticals, Inc.

    Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Penicillin-Resistant Streptococcus pneumoniae (PRSP). For more information, please visit: www.acurxpharma.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential of Ibezapolstat, Acurx's future expectations, plans and prospects, including without limitation, Acurx's expectations regarding its growth, strategy, progress and timing of its clinical trials, the potential of its antibiotics, and its intellectual property protection. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the possibility that data from clinical trials will be inconsistent with the data observed in subsequent clinical trials, 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 United States Food and Drug Administration or equivalent foreign regulatory agencies where approval is sought, whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed, competition from third parties that are developing products for similar uses, Acurx's ability to obtain, maintain and protect its intellectual property, Acurx's dependence on third parties for development and manufacture of product candidates including to supply any clinical trials, Acurx's ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and the impacts of public health pandemics such as COVID-19 on business operations including its clinical trials. Additional detailed information concerning a number of the important factors that could cause actual results to differ materially from the forward-looking information contained in this release is readily available in Acurx's publicly filed Registration Statement on Form S-1 and will also be included in quarterly, annual and other reports. Acurx disclaims any obligation to update developments of these risk factors or to announce publicly any revision to any of the forward-looking statements contained in this release, or to make corrections to reflect future events or developments.

    Investor Contact:

    Acurx Pharmaceuticals, Inc.

    David P. Luci, Co-Founder & Managing Partner 917-533-1469

    Cision View original content:https://www.prnewswire.com/news-releases/acurx-announces-filing-of-provisional-patent-application-for-ibezapolstat-to-treat-cdi-while-reducing-recurrence-of-infection-and-improving-the-health-of-the-gut-microbiome-301326841.html

    SOURCE Acurx Pharmaceuticals, Inc.

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  3. STATEN ISLAND, N.Y., June 29, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) (the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today the closing of its previously announced underwritten initial public offering of 2,875,000 newly-issued shares of common stock, including the full exercise by the underwriters of their option to purchase 375,000 additional shares of common stock, at a price to the public of $6.00 per share. The shares are listed for trading on the Nasdaq Capital Market under the ticker symbol "ACXP." The net proceeds to the Company from the offering, after deducting the underwriter discounts and commissions and…

    STATEN ISLAND, N.Y., June 29, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) (the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today the closing of its previously announced underwritten initial public offering of 2,875,000 newly-issued shares of common stock, including the full exercise by the underwriters of their option to purchase 375,000 additional shares of common stock, at a price to the public of $6.00 per share. The shares are listed for trading on the Nasdaq Capital Market under the ticker symbol "ACXP." The net proceeds to the Company from the offering, after deducting the underwriter discounts and commissions and estimated offering expenses, were approximately $14.8 million.

    Alexander Capital L.P. acted as lead book-running manager for the offering. Network 1 Financial Securities, Inc. acted as co-manager.

    A registration statement on Form S-1 relating to these securities was declared effective by the Securities and Exchange Commission ("SEC") on June 24, 2021. A final prospectus relating to the offering was filed with the SEC and is available on the SEC's website at http://www.sec.gov. Copies of the final prospectus may be obtained from: Alexander Capital, L.P., 17 State Street, New York, New York 10014, (212) 687-5650, .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company being offered, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Acurx Pharmaceuticals, Inc.

    Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Penicillin-Resistant Streptococcus pneumoniae (PRSP).  For more information, please visit: www.acurxpharma.com.

    Investor Contact:

    David P. Luci, President and Chief Executive Officer

    Acurx Pharmaceuticals, Inc.

    Phone: (917) 533-1469

    Cision View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-announces-closing-of-initial-public-offering-of-common-stock-and-full-exercise-of-underwriters-option-to-purchase-additional-shares-301322424.html

    SOURCE Acurx Pharmaceuticals, LLC

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