Acurx Pharmaceuticals LLC

Acurx Pharmaceuticals, Inc. operates as a clinical stage biopharmaceutical company, which engages in developing new antibiotics for infections caused by bacteria listed as priority pathogens. Its approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme. Its research and development pipeline includes early-stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococcus and Penicillin-Resistant Streptococcus pneumoniae. The company was founded by David P. Luci, Robert G. Shawah and Robert J. DeLuccia in July 2017 and is headquartered in New York, NY.

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Acurx Pharmaceuticals excels in Q1, eyes partnerships and funding

Acurx Pharmaceuticals showcased strong performance in Q1 2024 with positive data, successful FDA outcomes, and robust Phase III trial preparations.
While facing challenges in costs, timelines, and partnership negotiations, the company remains optimistic about its future prospects and strategic opportunities.
Strategic partnerships, regulatory advancements, and potential funding from the PASTEUR Act present avenues for growth and development in Acurx's antibiotic pipeline.
Overall, Acurx Pharmaceuticals is well-positioned to capitalize on its strengths, address challenges effectively, and leverage opportunities for continued success.

Acurx Pharmaceuticals progresses ibezapolstat towards Phase III trials

Acurx Pharmaceuticals is advancing ibezapolstat towards Phase III trials for C. difficile infection treatment
Despite financial challenges, the company is actively seeking partnerships and funding opportunities
The successful Phase II meeting with the FDA and new patent grant are key milestones for Acurx
Optimism surrounds the potential impact of ibezapolstat on improving C. difficile treatment

Acurx Pharmaceuticals reports Q3 loss, eyes growth through innovation and partnerships

Acurx Pharmaceuticals faces challenges in addressing potential dilution concerns and providing detailed insights into regulatory initiatives and Phase III trials. However, the company's strong pipeline, successful FDA meeting, and focus on innovation position it well for growth and expansion.

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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.

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

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

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.

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

Acurx Pharmaceuticals, Inc. to Discuss Fourth Quarter and Full Year 2023 Financial Results on March 18, 2024 Conference Call and Provide Business Update

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.

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

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.

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

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.

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

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.

Acurx Sell-Off Presents Opportunity Before Upcoming Data Release

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.

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

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.

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

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.

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

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.

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

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.

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

Acurx is a promising antibiotic company with perfect Phase 2a data in treating C. difficile infection. The company is developing a novel antibiotic, ibezapolstat, which could be the first new class of antibiotics in decades. Ibezapolstat has shown promising clinical efficacy, with high cure rates, no infection recurrence, and minimal side effects, making it a potential game-changer in the treatment of C. difficile infections.

Acurx Undervalued And Set For Potential M&A With Next-Gen C. Diff Treatment

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.

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

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.

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

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.

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

Based on observed aggregate blinded data the Company has determined that both treatments, ibezapolstat and the control antibiotic vancomycin, have performed as expected High rates of Clinical Cure were observed without any emerging safety concerns Data will be analyzed and topline efficacy results will be reported as soon as possible This successful milestone will allow advancement of this first-in-class, FDA QIDP/Fast Track-designated antibiotic candidate to Phase 3 clinical trials more expeditiously STATEN ISLAND, N.Y. , Oct. 2, 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 has discontinued the Phase 2b clinical trial of its lead antibiotic candidate, ibezapolstat, for the treatment of patients with Clostridioides difficile infection (CDI) due to success.

Acurx Pharmaceuticals Announces Successful Completion and Early Discontinuation of the Ibezapolstat Phase 2b Trial for Treatment of C. difficile Infection

Ibezapolstat is currently enrolling in a Phase 2b trial for C. difficile infection in U.S. centers across the country and nearing its goal to reach a targeted 36 patients at which point an Interim Analysis of the unblinded primary clinical endpoint and safety data will be reviewed by an Independent Data Monitoring Committee Ibezapolstat has received FDA QIDP and Fast-Track Designation Also presented was an update on the Company's pre-clinical antibiotic program in Lead Optimization stage for systemic gram-positive bacterial infections, including Acute Bacterial Skin and Skin Structure Infections caused by MRSA The company's preclinical pipeline also targets systemic infections caused by other gram-positive bacteria such as VRE and DRSP which are expected to be QIDP and Fast-Track eligible as product candidates advance in development STATEN ISLAND, N.Y.

Acurx Announces Presentation and Update of Its pol IIIC R&D Pipeline at the World Antimicrobial Resistance Scientific Congress

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.

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

Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP ) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Rob Shawah - CFO Dave Luci - President and CEO Conference Call Participants Ed Arce - HC. Wainwright Michael Okunewitch - Maxim Group Jim Molloy - Alliance Global Partners Operator Greetings, and welcome to the Acurx Pharmaceuticals to discuss Second Quarter 2023 Financial Results and Business Update.

Acurx Pharmaceuticals, Inc. (ACXP) Q2 2023 Earnings Call Transcript

STATEN ISLAND, N.Y. , Aug. 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 second quarter ended June 30, 2023.

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

STATEN ISLAND, N.Y. , July 24, 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 second quarter 2023 financial results on Monday, August 14, 2023, at 8:00 am ET before the U.S. financial markets open.

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

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.

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

STATEN ISLAND, N.Y. , June 15, 2023 /PRNewswire/ -- Acurx Pharmaceuticals (Nasdaq: ACXP), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that Company CEO, David P.

Acurx Pharmaceuticals to Participate in the Maxim Group LLC Virtual Healthcare Conference on Tuesday, June 20, 2023 to Thursday, June 22, 2023 at 9 am ET

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