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Acurx Announces Successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for Ibezapolstat in the Treatment of C. difficile Infection

  • Agreement with FDA reached on key elements to move forward with our international Phase 3 clinical trial program Agreement also reached with FDA on complete non-clinical and clinical development plan for filing of a New Drug Application for marketing approval Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI) SME (Small and Medium-sized Enterprise) designation has been granted by the EMA (European Medicines Agency), which allows Acurx to benefit from fee incentives and other support from the EMA for EU Marketing Authorization Acurx is now preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada Ibezapolstat has previously received FDA QIDP and Fast-Track Designation from FDA STATEN ISLAND, N.Y.
    05/15/2024

Acurx Pharmaceuticals, Inc. Reports First Quarter 2024 Results and Provides Business Update

  • STATEN ISLAND, N.Y. , May 15, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a clinical 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, 2024.
    05/15/2024
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Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results at ESCMID Global 2024 Scientific Conference

  • STATEN ISLAND, N.Y. , May 2, 2024 /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 results from the ibezapolstat Phase 2 clinical trial in patients with C.
    Thu, May. 02, 2024

Acurx Pharmaceuticals Announces Presentation of Ibezapolostat Phase 2 Clinical Trial Results at upcoming ESCMID 2024 Scientific Conference

  • STATEN ISLAND, N.Y., April 25, 2024 /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 results from the ibezapolstat Phase 2 clinical trial in patients with C.
    Thu, Apr. 25, 2024

Acurx Pharmaceuticals, Inc. Announces Participation in the LD Micro Invitational XIV

  • Staten Island, New York--(Newsfile Corp. - March 21, 2024) - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) announced today that it will be presenting at The 14th Annual LD Micro Invitational at the Sofitel New York on April 8th-9th, 2024. The event is expected to feature 80 companies presenting in half-hour increments, as well as private 1:1 meetings.
    Thu, Mar. 21, 2024

Acurx Pharmaceuticals, Inc. (ACXP) Q4 2023 Earnings Call Transcript

  • Acurx Pharmaceuticals, Inc. (ACXP) Q4 2023 Earnings Call Transcript
    Mon, Mar. 18, 2024

Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update

  • STATEN ISLAND, N.Y. , March 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the fourth quarter and full year ended December 31, 2023.
    Mon, Mar. 18, 2024
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Acurx Pharmaceuticals, Inc. to Discuss Fourth Quarter and Full Year 2023 Financial Results on March 18, 2024 Conference Call and Provide Business Update

  • STATEN ISLAND, N.Y. , March 4, 2024 /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 fourth quarter and full year 2023 financial results on Monday, March 18, 2024, at 8:00 am ET before the U.S. financial markets open.
  • 03/04/2024

Acurx Announces FDA Has Granted an End of Phase 2 Meeting for Ibezapolstat for C. difficile Infection and the European Medicines Agency Granted SME Designation for Ibezapolstat EU Development

  • As previously announced, planning is underway with FDA to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI) As anticipated, an End of Phase 2 Meeting (EOP2) with FDA is now confirmed to occur in late April 2024 to finalize the Phase 3 development plan Per FDA Guidance, Acurx also announced it has submitted the required pre-meeting Briefing Document to FDA yesterday, February 26, 2024 SME (Small and Medium-sized Enterprise) designation has been granted by the EMA (European Medicines Agency) which allows Acurx to benefit from fee incentives and other support from the EMA for EU Marketing Authorization Ibezapolstat has previously received FDA QIDP and Fast-Track Designation STATEN ISLAND, N.Y.
  • 02/27/2024

Acurx Announces Positive Extended Clinical Cure Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

  • In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection Further analyses will be forthcoming as data become available regarding effects on bile acid metabolism and pharmacokinetic data Preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials Ibezapolstat has previously received FDA QIDP and Fast-Track Designation STATEN ISLAND, N.Y. , Jan. 29, 2024 /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 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.
  • 01/29/2024

Acurx Pharmaceuticals to Present at the Microcap Conference, January 31, 2024 - February 1, 2024

  • STATEN ISLAND, N.Y. , Jan. 23, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. ("Acurx" or the "Company") (NASDAQ: "ACXP"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that David P.
  • 01/23/2024

Acurx Sell-Off Presents Opportunity Before Upcoming Data Release

  • Acurx shares opened ~25% lower on Jan 17th, after releasing positive data suggesting its C. diff antibiotic outperformed standard treatment in restoring the gut microbiome. The decline in share price since then may be due to misaligned investor expectations regarding the release of sustained clinical cure rates. Acurx is expected to release additional data, including 94-day sustained clinical cure rates, which could further establish its antibiotic as a preferred treatment for C. diff.
  • 01/22/2024

Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

  • Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C.
  • 01/17/2024

Acurx to present at the 42nd Annual J.P. Morgan Healthcare Conference

  • STATEN ISLAND, N.Y. , Jan. 3, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") today announced that President and Chief Executive Officer David P.
  • 01/03/2024

Acurx Announces Positive Phase 2b Results Showing 100% of Patients Who Had Clinical Cure with Ibezapolstat Also Had Sustained Clinical Cure

  • All 15 ibezapolstat-treated patients in Phase 2b who achieved Clinical Cure (CC) at end of treatment (EOT) remained free of C. difficile Infection (CDI) recurrence through one month after EOT, for a Sustained Clinical Cure (SCC) rate of 100%  2 of 14 patients treated with standard of care, oral vancomycin, experienced recurrent infection within one month after EOT for a SCC of 86% 100% of the 25 ibezapolstat-treated patients in Phase 2 (Phase 2a and 2b) who had CC at EOT remained cured through one month after EOT Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints, from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days and comparative effects vs vancomycin on the gut microbiome Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials STATEN ISLAND, N.Y.
  • 12/11/2023

Acurx Pharmaceuticals, Inc. (ACXP) Q3 2023 Earnings Call Transcript

  • Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP ) Q3 2023 Earnings Conference Call November 14, 2023 8:00 AM ET Company Participants Robert Shawah - CFO David Luci - President & CEO Robert DeLuccia - Executive Chairman Conference Call Participants Michael Okunewitch - Maxim Group Thomas Yip - H.C. Wainwright James Molloy - Alliance Global Partners Operator Ladies and gentlemen, good morning, and welcome to the Acurx Pharmaceuticals Third Quarter 2023 Earnings Conference Call.
  • 11/14/2023

Acurx Pharmaceuticals, Inc. Reports Third Quarter 2023 Results and Provides Business Update

  • STATEN ISLAND, N.Y. , Nov. 14, 2023 /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 certain financial and operational results for the third quarter ended September 30, 2023.
  • 11/14/2023

Acurx Announces Positive Top-Line Ibezapolstat Phase 2 Efficacy Results with 96% Clinical Cure Rate in Patients with C. difficile Infection

  • In a total of 26 ibezapolstat-treated patients in Phases 2a and 2b, the Clinical Cure rate is 96% Meets protocol primary objective of assessing the primary efficacy endpoint of the Clinical Cure rate after 10 days of oral treatment Ibezapolstat was well tolerated; no drug-related Serious Adverse Events Further analyses forthcoming regarding secondary and exploratory endpoints, including Sustained Clinical Cure data, Extended Clinical Cure data up to 94 days and comparative effects on gut microbiome Preparation underway for End-of-Phase 2 FDA Meeting and advancement to Phase 3 Ibezapolstat has previously received FDA Qualified Infectious Disease Product and Fast-Track DesignationManagement will be available for Q&A on November 14, 2023 earnings call https://www.acurxpharma.com/news-media/press-releases/detail/65/acurx-pharmaceuticals-to-discuss-third-quarter-2023 STATEN ISLAND, N.Y. , Nov. 2, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced efficacy results from the Phase 2 clinical trial (Phase 2a segment and Phase 2b segment) of ibezapolstat for the treatment of C.
  • 11/02/2023

Acurx Pharmaceuticals to Discuss Third Quarter 2023 Financial Results and Provide Business Update

  • STATEN ISLAND, N.Y. , Oct. 25, 2023 /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 discuss its third quarter 2023 financial results on Tuesday, November 14, 2023, at 8:00 am ET before the U.S. financial markets open.
  • 10/25/2023

Acurx Announces Ibezapolstat Scientific Posters and Presentations at ClostPath 2023 and IDWeek 2023 Scientific Conferences

  • Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome A podium presentation entitled First of a New Class of Antibiotics (pol IIIC Inhibitors) Targeting CDC/FDA/WHO Priority Pathogens; Preparing for the Next Pandemic: Antimicrobial Resistance in Gram-positive Bacterial Infections Ibezapolstat has previously received FDA QIDP and Fast-Track Designation STATEN ISLAND, N.Y.
  • 10/19/2023

Acurx Pharmaceuticals to Present at the H.C. Wainwright 25th Annual Global Investment Conference September 11-13, 2023

  • STATEN ISLAND, N.Y. , Aug. 22, 2023 /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 David P.
  • 08/22/2023

Acurx Pharmaceuticals to Present at the Emerging Growth Conference on July 12, 2023

  • Acurx invites individual and institutional investors, financial advisors and analysts to attend its real-time, interactive presentation at the Emerging Growth Conference. STATEN ISLAND, N.Y.
  • 06/20/2023

Acurx Pharmaceuticals, Inc. (ACXP) Q4 2022 Earnings Call Transcript

  • Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP ) Q4 2022 Earnings Conference Call March 16, 2023 8:00 AM ET Company Participants Robert Shawah - Co-Founder & Chief Financial Officer David Luci - President & Chief Executive Officer Conference Call Participants Jason McCarthy - Maxim James Molloy - Alliance Global Partners Operator Greetings and welcome to the Acurx Pharmaceutical Fourth Quarter and Full Year 2022 Financial Results and Business Update. [Operator Instructions] As a reminder, this conference is being recorded.
  • 03/16/2023

Acurx Pharmaceuticals to Present at the Emerging Growth Conference on January 25, 2023

  • Acurx invites individual and institutional investors, financial advisors and analysts to attend its real-time, interactive question and answer session at the Emerging Growth Conference STATEN ISLAND, N.Y. , Jan. 16, 2023  /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, is pleased to announce that it has been invited to present at the Emerging Growth Conference on January 25, 2023.
  • 01/16/2023

Acurx Pharmaceuticals, Inc. (ACXP) Q3 2022 Earnings Call Transcript

  • Start Time: 08:30 January 1, 0000 8:49 AM ET Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP ) Q3 2022 Earnings Conference Call November 14, 2022, 08:30 AM ET Company Participants David Luci - President and CEO Robert Shawah - Co-Founder and CFO Conference Call Participants Jason McCarthy - Maxim Group Operator Greetings. Welcome to Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022.
  • 11/14/2022

Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022 Conference Call and Provide Business Update

  • STATEN ISLAND, N.Y. , Nov. 1, 2022 /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 2022 third quarter financial results on Monday, November 14, 2022, at 8:30 am ET before the U.S. financial markets open.
  • 11/01/2022

Acurx Pharmaceuticals, Inc. (ACXP) CEO David Luci on Q2 2022 Results - Earnings Call Transcript

  • Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP ) Q2 2022 Earnings Conference Call August 16, 2022 8:30 AM ET Company Participants Robert Shawah - CFO David Luci - CEO Conference Call Participants Jim Molloy - Alliance Global Partners Operator Greetings. Welcome to Acurx Pharmaceuticals' Second Quarter 2022 Results and Business Update.
  • 08/16/2022

Acurx Pharmaceuticals, Inc. to Discuss 2022 Second Quarter Financial Results on August 16, 2022 Conference Call and Provide Business Update

  • STATEN ISLAND, N.Y. , Aug. 4, 2022 /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 2022 second quarter financial results on Tuesday, August 16, 2022, at 8:30 am ET before the U.S. financial markets open.
  • 08/04/2022

Acurx Pharmaceuticals, Inc.'s (ACXP) CEO David Luci on Q1 2022 Results - Earnings Call Transcript

  • Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP ) Q1 2022 Earnings Conference Call May 11, 2022 8:30 AM ET Company Participants Rob Shawah - Chief Financial Officer David Luci - President and Chief Executive Officer Conference Call Participants Chad Yahn - Maxim Group Joanne Lee - Maxim Group Operator Greetings and welcome to the Acurx Pharmaceuticals, Inc. First Quarter 2022 Results and Business Update. At this time, all participants are in a listen-only mode.
  • 05/11/2022

Acurx Pharmaceuticals, Inc. to Discuss 2022 First Quarter Financial Results on May 11, 2022 Conference Call and Provide Business Update

  • STATEN ISLAND, N.Y. , April 29, 2022 /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 2022 first quarter financial results on Wednesday, May 11 2022, at 8:30 am ET before the U.S. financial markets open.
  • 04/29/2022

Acurx Pharmaceuticals, Inc. (ACXP) CEO David Luci on Q3 2021 Earnings Call Transcript

  • Acurx Pharmaceuticals, Inc. (ACXP) CEO David Luci on Q3 2021 Earnings Call Transcript
  • 11/15/2021

Acurx Pharmaceuticals to Discuss 2021 Third Quarter Financial Results on November 15, 2021 Conference Call and Provide Business Update

  • STATEN ISLAND, N.Y., Oct. 27, 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 third quarter financial results on Monday, November 15, 2021, at 8:30 am ET before the U.S. financial markets open.
  • 10/27/2021

Acurx Presents Positive Ibezapolstat Microbiome Data from Its Phase 2a Trial at IDWeek

  • STATEN ISLAND, N.Y., Oct. 4, 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 a scientific abstract and poster were presented on September 29 th at the Infectious Disease Society of America (IDSA) IDWeek™   2021 Virtual Conference entitled: "An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective Spectrum (GPSS™) Antibiotic, for Patients with Clostridioides difficile Infection.
  • 10/04/2021

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

  • Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his companyNew York, New York--(Newsfile Corp. - September 13, 2021) - Acurx Pharmaceuticals (NASDAQ: ACXP) is a clinical-stage biopharmaceutical company developing a new class of antibiotics that could present the most meaningful changes to that sector in more than four decades. Its lead program utilizes ibezapolstat to target the debilitating C. difficile infection. Other pipeline programs and drugs are expected to target and treat numerous other gram-positive infections.That strategy could be advantageous on several fronts and...
  • 09/13/2021

New Antibiotics Needed For Drug-Resistant Infections, Acurx Pharmaceuticals May Have The Answers

  • New Antibiotics Needed For Drug-Resistant Infections, Acurx Pharmaceuticals May Have The Answers
  • 08/27/2021

Acurx Pharmaceuticals to Present at the Emerging Growth Conference on August 18, 2021

  • STATEN ISLAND, N.Y. , Aug. 12, 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 David P.
  • 08/12/2021

Acurx Pharmaceuticals to Discuss 2021 Second Quarter Financial Results on August 17, 2021 Conference Call and Provide Business Update

  • 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.
  • 07/28/2021

Acurx Announces New Ibezapolstat Data on Anti-Recurrence Mechanisms in CDI at Prominent International Conference

  • STATEN ISLAND, N.Y. , July 1, 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 using specimens from a Phase 1 healthy volunteer trial and a novel analysis technique, beneficial changes potentially predictive of lower risk of CDI (Clostridioides difficile Infection) recurrence were associated with ibezapolstat compared to vancomycin.
  • 07/01/2021

ACURX PHARMACEUTICALS, Inc. Announces Closing of INITIAL Public Offering OF common stock AND FULL EXERCISE OF UNDERWRITERS' OPTION TO PURCHASE ADDITIONAL SHARES

  • 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.
  • 06/29/2021
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