Acurx Pharmaceuticals(ACXP)
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Acurx Pharmaceuticals, Inc. Announces Closing of $1.1 Million Registered Direct Offering
Prnewswire· 2025-03-10 20:30
Core Viewpoint - Acurx Pharmaceuticals, Inc. has successfully closed a registered direct offering of 2,745,000 shares at a price of $0.40 per share, along with a concurrent private placement of unregistered short-term warrants to purchase up to 8,235,000 shares at the same exercise price, aiming to raise approximately $1.1 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The registered direct offering involved 2,745,000 shares of common stock priced at $0.40 each, with a concurrent issuance of short-term warrants for 8,235,000 shares [1]. - The total gross proceeds from the offering were approximately $1.1 million before deducting fees and expenses [2]. - The warrants will be exercisable upon stockholder approval and will expire 24 months after such approval [1]. Group 2: Regulatory and Compliance Information - The shares were offered under a "shelf" registration statement filed with the SEC, which became effective on July 11, 2022 [3]. - The warrants and underlying shares have not been registered under the Securities Act and may not be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - Acurx Pharmaceuticals is focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, particularly Gram-positive bacteria [6]. - The lead product candidate, ibezapolstat, is ready for Phase 3 trials for treating C. difficile infections, with plans for international clinical trials this year [6]. - The company's pipeline includes antibiotic candidates for various serious bacterial infections, including MRSA and drug-resistant Streptococcus pneumoniae [6].
Acurx Pharmaceuticals, Inc. Announces $1.1 Million Registered Direct Offering
Prnewswire· 2025-03-07 13:00
Core Viewpoint - Acurx Pharmaceuticals has announced a definitive agreement for the purchase and sale of 2,745,000 shares of its common stock at a price of $0.40 per share, along with a concurrent private placement of unregistered short-term warrants to purchase up to 8,235,000 shares of common stock [1][2] Group 1: Offering Details - The total gross proceeds from the offering are expected to be approximately $1.1 million before deducting fees and expenses [2] - The warrants will have an exercise price of $0.40 per share and will expire twenty-four months after stockholder approval [1] - The closing of the offering is anticipated to occur around March 10, 2025, subject to customary closing conditions [1] Group 2: Company Background - Acurx Pharmaceuticals is focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [6] - The company's lead product candidate, ibezapolstat, is ready for Phase 3 trials for the treatment of C. difficile infection, with plans for international clinical trials this year [6] - The R&D pipeline includes antibiotic candidates targeting Gram-positive bacteria, including MRSA, VRE, and anthrax [6]
Acurx Announces Publication of Nonclinical In Vivo Data Differentiating Ibezapolstat's Gut Microbiome Effects from Other Anti-CDI Antibiotics
Prnewswire· 2025-03-03 13:00
Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of C. difficile Infection (CDI), with recent study results indicating its potential competitive advantage over existing antibiotics [1][5][19] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, particularly CDI [19] - The company’s lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial that inhibits DNA replication in Gram-positive bacteria [19][13] Clinical Trial Progress - Acurx has received positive regulatory guidance from the European Medicines Agency (EMA) for its Phase 3 program, which includes two planned international trials designed to demonstrate non-inferiority to vancomycin [5][6] - The Phase 2 clinical trials showed a Clinical Cure rate of 96% for ibezapolstat, with 100% of patients remaining cured one month after treatment [9][10] Study Findings - A recent study published in the Journal of Antimicrobial Agents and Chemotherapeutics compared the gut microbiome effects of ibezapolstat with other CDI antibiotics, revealing that ibezapolstat has a narrower spectrum of microbiome alteration compared to broader-spectrum antibiotics like vancomycin and metronidazole [2][3] - The study indicated that ibezapolstat treatment resulted in less pronounced changes in microbiome diversity and increased beneficial bacteria, which may contribute to its potential advantages in treating CDI [2][3][12] Regulatory Designations - Ibezapolstat has been granted FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation, highlighting its importance in addressing urgent medical needs [14][19] - The CDC has classified C. difficile as an urgent threat, emphasizing the necessity for new antibiotics like ibezapolstat [14][15] Market Context - CDI is a significant healthcare issue, with estimates of approximately 600,000 infections annually in the U.S. and a mortality rate of about 9.3% [16][15] - The recurrence rate for current CDI treatments ranges from 20% to 40%, indicating a substantial market opportunity for more effective therapies like ibezapolstat [16]
Acurx Pharmaceuticals to Discuss Fourth Quarter and Full Year 2024 Financial Results on March 18, 2025 Conference Call and Provide Business Update
Prnewswire· 2025-02-28 13:00
Core Viewpoint - Acurx Pharmaceuticals is preparing to discuss its fourth quarter and full year 2024 financial results on March 18, 2025, highlighting its focus on developing a new class of antibiotics for difficult-to-treat bacterial infections [1][2]. Group 1: Company Overview - Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [4]. - The company's lead antibiotic candidate, Ibezapolstat, is preparing for international Phase 3 clinical trials aimed at treating patients with C. difficile Infection (CDI) [2][3]. - Ibezapolstat is a novel, orally administered antibiotic that selectively targets Gram-positive bacteria while preserving the gut microbiome [2][3]. Group 2: Regulatory and Clinical Development - Acurx has received positive regulatory guidance from the EMA, confirming that its clinical and non-clinical data supports the advancement of the Ibezapolstat Phase 3 program [3]. - The FDA has designated Ibezapolstat as a Qualified Infectious Disease Product (QIDP) and granted it "Fast Track" designation for CDI treatment, indicating the urgency and need for new antibiotics in this area [3]. - The CDC has classified C. difficile as an urgent threat, underscoring the critical need for new treatment options [3]. Group 3: Upcoming Events - Acurx will host a conference call on March 18, 2025, at 8:00 a.m. ET to discuss its financial results and provide a business update [2].
Acurx Announces Publication of Positive Results from an In-Silico Study Predicting the Microbiome-Restorative Potential of Ibezapolstat in the Treatment of CDI
Prnewswire· 2025-02-24 13:00
Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of Clostridioides difficile Infection (CDI), supported by recent study findings that elucidate its selective activity against harmful bacteria while preserving beneficial gut microbiota [1][2][3] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, particularly those caused by Gram-positive bacteria [19] - The company's lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial designed to inhibit DNA polymerase IIIC, leading to bacterial cell death [19][13] Clinical Trial Progress - Ibezapolstat is preparing to enter international Phase 3 clinical trials, having received positive regulatory guidance from the European Medicines Agency (EMA) confirming the adequacy of the clinical and non-clinical data submitted [5][6] - The Phase 3 trial will involve an estimated 450 subjects, randomized in a 1:1 ratio to receive either ibezapolstat or standard-of-care vancomycin, with the primary efficacy analysis focusing on clinical cure rates and recurrence reduction [6][10] Study Findings - Recent research published in the Journal of Antimicrobial Agents and Chemotherapeutics highlights the microbiome-restorative potential of ibezapolstat, showing that it allows for the regrowth of beneficial gut microbiota while effectively targeting C. difficile [1][2][3] - The study utilized in silico genomic analysis to explain the narrower than expected spectrum of activity of ibezapolstat observed in clinical trials, indicating that certain beneficial taxa are naturally resistant to the drug [2][3] Efficacy and Safety Data - In combined Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96% (25 out of 26 patients), with no drug-related serious adverse events reported [9][10] - The treatment was well-tolerated, with mild gastrointestinal adverse events that resolved without treatment, and showed promising results in maintaining a healthy gut microbiome [9][12] Regulatory Designations - Ibezapolstat has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, which facilitate its development as a treatment for CDI [14] - The CDC has classified C. difficile as an urgent threat, underscoring the need for new antibiotics to address this significant healthcare challenge [14][15]
Acurx Pharmaceuticals, Inc. Announces Closing of $2.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Prnewswire· 2025-01-07 22:00
Core Viewpoint - Acurx Pharmaceuticals, Inc. has successfully closed a registered direct offering of 2,463,058 shares of common stock at a price of $1.015 per share, raising approximately $2.5 million in gross proceeds, which will be used for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering included a concurrent private placement of unregistered warrants to purchase up to 2,463,058 shares of common stock, with an exercise price of $0.90 per share, exercisable upon issuance and expiring five years after issuance [1][2]. - H.C. Wainwright & Co. served as the exclusive placement agent for the offering [2]. Group 2: Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [6]. - The company's lead product candidate, ibezapolstat, is aimed at treating C. difficile infection and is Phase 3 ready, with plans to initiate international clinical trials [6]. - The R&D pipeline includes antibiotic candidates targeting Gram-positive bacteria, such as MRSA, VRE, and drug-resistant Streptococcus pneumoniae, as well as a preclinical oral product candidate for ABSSSI and a development program for inhaled anthrax [6].
Acurx Pharmaceuticals, Inc. Announces $2.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Prnewswire· 2025-01-06 22:35
Core Viewpoint - Acurx Pharmaceuticals, Inc. has announced a definitive agreement for the purchase and sale of 2,463,058 shares of its common stock at a price of $1.015 per share, along with a concurrent private placement of unregistered warrants to purchase the same number of shares at an exercise price of $0.90 per share [1][2]. Group 1: Offering Details - The total gross proceeds from the offering are expected to be approximately $2.5 million before deducting fees and expenses [2]. - The closing of the offering is anticipated to occur on or about January 7, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and other general corporate purposes [2]. Group 3: Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [6]. - The company's lead product candidate, ibezapolstat, is ready for Phase 3 trials for the treatment of C. difficile infection, with plans for international clinical trials this year [6]. - Acurx's research and development pipeline includes antibiotic candidates targeting Gram-positive bacteria, including MRSA, VRE, and anthrax [6].
Acurx Receives Positive Regulatory Guidance from EMA for Ibezapolstat Phase 3 Program for C. Difficile Infection (CDI)
Prnewswire· 2025-01-06 13:30
Core Insights - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, to international Phase 3 clinical trials for treating C. difficile Infection (CDI) following positive regulatory guidance from the EMA and FDA [1][5][10] Regulatory Developments - The company received constructive feedback from the EMA during its Scientific Advice Procedure, confirming that the submitted clinical, non-clinical, and CMC information supports the advancement of the ibezapolstat Phase 3 program [1][5] - Acurx is preparing to submit requests for regulatory guidance to initiate clinical trials in the EU, UK, Japan, and Canada [2][5] Clinical Trial Design - The Phase 3 program will consist of two non-inferiority trials comparing ibezapolstat to vancomycin, with an estimated 450 subjects randomized in a 1:1 ratio [3][8] - The primary endpoint is Clinical Cure, assessed two days after a 10-day oral treatment [3][8] Phase 2 Clinical Trial Results - In the completed Phase 2 trials, ibezapolstat demonstrated a Clinical Cure rate of 96% (25 out of 26 patients) [7][8] - The Phase 2a segment showed 100% cure in 10 patients treated with ibezapolstat [6][8] - The Phase 2b segment reported that 14 out of 14 patients in the vancomycin control arm also achieved Clinical Cure [8] Mechanism of Action and Microbiome Impact - Ibezapolstat is a novel antibiotic that selectively targets Gram-positive bacteria, including C. difficile, while preserving healthy gut microbiota [10][14] - The treatment leads to favorable changes in bile acid metabolism, potentially reducing CDI recurrence [9][13] Market Context - CDI is a significant healthcare issue, with approximately 500,000 infections and 20,000 deaths annually in the U.S. [12] - The recurrence rate for current CDI treatments ranges from 20% to 40% [12]
Here's Why Acurx Pharmaceuticals (ACXP) Is a Great 'Buy the Bottom' Stock Now
ZACKS· 2024-11-28 15:56
Core Viewpoint - Acurx Pharmaceuticals, Inc. (ACXP) has experienced a 17.6% decline in share price over the past week, but the formation of a hammer chart pattern suggests potential support and a possible trend reversal in the future [1][2]. Technical Analysis - The hammer chart pattern indicates a potential bottoming out of the stock, with reduced selling pressure likely [2][4]. - This pattern typically forms during a downtrend, where the stock opens lower, makes a new low, but then closes near its opening price, indicating buying interest [3][4]. - Hammer candles can appear on various timeframes and are utilized by both short-term and long-term investors [4]. Fundamental Analysis - There has been a recent upward trend in earnings estimate revisions for ACXP, which is a bullish indicator [6]. - Over the last 30 days, the consensus EPS estimate for the current year has increased by 9.2%, indicating analysts expect better earnings than previously predicted [7]. - ACXP holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, suggesting it is likely to outperform the market [8].
Acurx Board of Directors Approves Bitcoin as Treasury Reserve Asset
Prnewswire· 2024-11-20 12:01
Core Viewpoint - Acurx Pharmaceuticals has approved the purchase of up to $1 million in Bitcoin as a treasury reserve asset, reflecting the growing demand and acceptance of Bitcoin as a primary asset class [1][2]. Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, specifically Gram-positive bacteria [3]. Treasury Strategy - The company's President & CEO, David P. Luci, stated that Bitcoin's limited supply and inflation-resistant characteristics make it a functional store of value, and this new treasury strategy will not impact the company's drug development plans [2]. - The treasury strategy is aimed at cash that is not needed over the next 12 to 18 months, leveraging the recent approval of Bitcoin ETFs and increasing institutional support [2]. Research and Development Pipeline - Acurx's R&D pipeline includes antibiotic candidates targeting serious infections such as Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and drug-resistant Streptococcus pneumoniae (DRSP) [3].