Acurx Receives Favorable EMA Opinion on Pediatric Investigation Plan for Ibezapolstat in Treating C. difficile Infection in Children
Positive EMA Opinion: Acurx Pharmaceuticals received a favorable opinion from the European Medicines Agency's Pediatric Committee for its Pediatric Investigation Plan (PIP) regarding ibezapolstat, an antibiotic for treating C. difficile infections in children, allowing the company to proceed with Phase 3 clinical trials in the EU.
Clinical Trial Readiness: Acurx is well-positioned to begin international Phase 3 trials, having received alignment from both the EMA and FDA on its clinical program, and has previously been granted designations that facilitate the development of ibezapolstat as a treatment for C. difficile infections.
Trade with 70% Backtested Accuracy
Analyst Views on ACXP
About ACXP
About the author
Acurx Pharmaceuticals to Discuss 2025 Financial Results on March 13, 2026
- Earnings Call Scheduled: Acurx Pharmaceuticals will hold an earnings call on March 13, 2026, at 8:00 AM ET to discuss its fourth quarter and full year 2025 financial results, which is expected to positively influence investor confidence.
- Clinical Trial Advancement: The company's antibiotic candidate, Ibezapolstat, is set to enter international Phase 3 clinical trials aimed at treating C. difficile infections, which could significantly enhance market opportunities for Acurx if successful.
- Regulatory Guidance Confirmation: Acurx has received final guidance from both EMA and FDA, confirming the clinical trial design and registration safety database requirements, laying a solid foundation for future market applications and demonstrating regulatory support for its development direction.
- Antibiotic Development Outlook: Ibezapolstat's designation as a QIDP and Fast Track status highlights its significance in antibiotic development, particularly in addressing the urgent threat posed by C. difficile as recognized by the CDC, which is expected to drive future growth for the company.
Acurx Pharmaceuticals to Release 2025 Financial Results
- Earnings Call Scheduled: Acurx Pharmaceuticals will hold a conference call on March 13, 2026, at 8:00 AM ET to discuss its full-year and Q4 2025 financial results, which is expected to positively influence investor confidence.
- Clinical Trial Advancement: The company's antibiotic candidate, Ibezapolstat, is set to enter international Phase 3 clinical trials aimed at treating C. difficile infections, which, if successful, will significantly enhance Acurx's competitive position in the antibiotic market.
- Regulatory Guidance Confirmation: Acurx has received final advice from both EMA and FDA confirming the non-inferiority study design and registration safety database requirements for Ibezapolstat, laying a solid foundation for future market applications and demonstrating regulatory support for its development path.
- Antibiotic Development Context: Ibezapolstat has been designated as a Qualified Infectious Disease Product (QIDP) by the FDA and granted Fast Track designation, highlighting its critical role in addressing the urgent threat posed by C. difficile infections, which is expected to drive market demand for new antibiotics.
"New to The Street Celebrates Milestone Episode #700 Airing Today at 6:30 PM ET on Bloomberg Television"
New to The Street Milestone: The business television platform "New to The Street" celebrated its 700th episode, airing on Bloomberg Television, highlighting its growth in various media channels and showcasing innovative companies in technology, finance, healthcare, and consumer culture.
Featured Companies: The episode featured several companies, including Lionscrest Advisors, DataVault AI, Pudgy Penguins, Peer To Peer Network, and Acurx Pharmaceuticals, each recognized for their contributions to their respective industries.
Lionscrest Advisors: This global advisory firm specializes in capital markets, M&A, and corporate finance, providing strategic insights to clients navigating complex financial landscapes.
DataVault AI and Others: DataVault AI focuses on AI-driven business intelligence and data management, while Pudgy Penguins has expanded into mainstream media and retail, and Acurx Pharmaceuticals is developing new antibiotics for challenging bacterial infections.
Acurx Pharmaceuticals, Inc. Reports Third Quarter Results and Provides Business Update
Financial Compliance and Stock Split: Acurx Pharmaceuticals executed a 1-for-20 reverse stock split, regaining compliance with Nasdaq's minimum bid price and stockholders' equity requirements, ensuring continued listing on the Nasdaq Stock Market.
Patent Developments: The company received a new patent from the Australian Patent Office for its DNA polymerase IIIC inhibitors, adding to its existing patents in the U.S. and other countries, which cover treatments for infections caused by Gram-positive bacteria.
Research and Development Updates: Acurx presented at IDWeek 2025, showcasing new data on its lead antibiotic candidate, ibezapolstat, which is preparing for Phase 3 clinical trials to treat C. difficile infections, and published significant findings in Nature Communications regarding its mechanism of action.
Financial Performance: Acurx reported a net loss of $2.0 million for Q3 2025, an improvement from the previous year's loss, with cash reserves increasing to $5.9 million, supported by recent fundraising efforts through warrant exercises and an equity line of credit.
Acurx Announces Publication in the Nature Communications Scientific Journal Documenting its Unique Targeting of DNA pol IIIC Gram-positive Priority Pathogens
Introduction of New Antibiotics: Acurx Pharmaceuticals is developing a new class of antibiotics, DNA polymerase IIIC inhibitors, targeting Gram-positive bacteria such as C. difficile, MRSA, and VRE, with their lead candidate, ibezapolstat, showing promising Phase 2 results for treating C. difficile infections.
Clinical Trial Success: Ibezapolstat demonstrated a 96% clinical cure rate in Phase 2 trials, with no recurrence of infection, and is now ready for Phase 3 trials in the U.S. and EU, supported by positive regulatory feedback from the FDA and EMA.
Research Collaboration: Acurx's collaboration with Leiden University Medical Center has provided structural insights into ibezapolstat's mechanism of action, aiding the development of new antibiotics against multi-drug-resistant pathogens.
Microbiome Preservation: Ibezapolstat treatment appears to maintain a healthy gut microbiome, showing favorable changes in bile acid metabolism that may reduce the likelihood of C. difficile recurrence compared to traditional treatments like vancomycin.
Acurx Announces New Data on its DNA pol IIIC Inhibitor Antibiotics Demonstrating a Potential Class Effect of Gut Microbiome Selectivity Presented at IDWeek 2025 Scientific Conference
Ibezapolstat's Unique Properties: Acurx Pharmaceuticals' ibezapolstat (IBZ) shows selective antibacterial activity in the gut, preserving beneficial bacteria and contributing to its effectiveness against C. difficile infection (CDI) without increasing the risk of recurrence.
Clinical Trial Success: The Phase 2 clinical trials demonstrated a 96% clinical cure rate for ibezapolstat in CDI patients, with 100% of those cured remaining free of recurrence, indicating its potential superiority over traditional treatments like vancomycin.
Microbiome-Sparing Effects: New data suggest that ibezapolstat may have a microbiome-sparing class effect, which is crucial for maintaining gut health and preventing CDI recurrence, a significant concern with existing antibiotics.
Regulatory Progress and Future Trials: Ibezapolstat has received FDA QIDP and Fast-Track Designations, and Acurx is preparing to initiate international Phase 3 trials, aiming to establish its efficacy and safety for broader use against Gram-positive bacterial infections.
Acurx Pharmaceuticals to Discuss 2025 Financial Results on March 13, 2026
- Earnings Call Scheduled: Acurx Pharmaceuticals will hold an earnings call on March 13, 2026, at 8:00 AM ET to discuss its fourth quarter and full year 2025 financial results, which is expected to positively influence investor confidence.
- Clinical Trial Advancement: The company's antibiotic candidate, Ibezapolstat, is set to enter international Phase 3 clinical trials aimed at treating C. difficile infections, which could significantly enhance market opportunities for Acurx if successful.
- Regulatory Guidance Confirmation: Acurx has received final guidance from both EMA and FDA, confirming the clinical trial design and registration safety database requirements, laying a solid foundation for future market applications and demonstrating regulatory support for its development direction.
- Antibiotic Development Outlook: Ibezapolstat's designation as a QIDP and Fast Track status highlights its significance in antibiotic development, particularly in addressing the urgent threat posed by C. difficile as recognized by the CDC, which is expected to drive future growth for the company.
Acurx Pharmaceuticals to Release 2025 Financial Results
- Earnings Call Scheduled: Acurx Pharmaceuticals will hold a conference call on March 13, 2026, at 8:00 AM ET to discuss its full-year and Q4 2025 financial results, which is expected to positively influence investor confidence.
- Clinical Trial Advancement: The company's antibiotic candidate, Ibezapolstat, is set to enter international Phase 3 clinical trials aimed at treating C. difficile infections, which, if successful, will significantly enhance Acurx's competitive position in the antibiotic market.
- Regulatory Guidance Confirmation: Acurx has received final advice from both EMA and FDA confirming the non-inferiority study design and registration safety database requirements for Ibezapolstat, laying a solid foundation for future market applications and demonstrating regulatory support for its development path.
- Antibiotic Development Context: Ibezapolstat has been designated as a Qualified Infectious Disease Product (QIDP) by the FDA and granted Fast Track designation, highlighting its critical role in addressing the urgent threat posed by C. difficile infections, which is expected to drive market demand for new antibiotics.
"New to The Street Celebrates Milestone Episode #700 Airing Today at 6:30 PM ET on Bloomberg Television"
New to The Street Milestone: The business television platform "New to The Street" celebrated its 700th episode, airing on Bloomberg Television, highlighting its growth in various media channels and showcasing innovative companies in technology, finance, healthcare, and consumer culture.
Featured Companies: The episode featured several companies, including Lionscrest Advisors, DataVault AI, Pudgy Penguins, Peer To Peer Network, and Acurx Pharmaceuticals, each recognized for their contributions to their respective industries.
Lionscrest Advisors: This global advisory firm specializes in capital markets, M&A, and corporate finance, providing strategic insights to clients navigating complex financial landscapes.
DataVault AI and Others: DataVault AI focuses on AI-driven business intelligence and data management, while Pudgy Penguins has expanded into mainstream media and retail, and Acurx Pharmaceuticals is developing new antibiotics for challenging bacterial infections.
Acurx Pharmaceuticals, Inc. Reports Third Quarter Results and Provides Business Update
Financial Compliance and Stock Split: Acurx Pharmaceuticals executed a 1-for-20 reverse stock split, regaining compliance with Nasdaq's minimum bid price and stockholders' equity requirements, ensuring continued listing on the Nasdaq Stock Market.
Patent Developments: The company received a new patent from the Australian Patent Office for its DNA polymerase IIIC inhibitors, adding to its existing patents in the U.S. and other countries, which cover treatments for infections caused by Gram-positive bacteria.
Research and Development Updates: Acurx presented at IDWeek 2025, showcasing new data on its lead antibiotic candidate, ibezapolstat, which is preparing for Phase 3 clinical trials to treat C. difficile infections, and published significant findings in Nature Communications regarding its mechanism of action.
Financial Performance: Acurx reported a net loss of $2.0 million for Q3 2025, an improvement from the previous year's loss, with cash reserves increasing to $5.9 million, supported by recent fundraising efforts through warrant exercises and an equity line of credit.
Acurx Announces Publication in the Nature Communications Scientific Journal Documenting its Unique Targeting of DNA pol IIIC Gram-positive Priority Pathogens
Introduction of New Antibiotics: Acurx Pharmaceuticals is developing a new class of antibiotics, DNA polymerase IIIC inhibitors, targeting Gram-positive bacteria such as C. difficile, MRSA, and VRE, with their lead candidate, ibezapolstat, showing promising Phase 2 results for treating C. difficile infections.
Clinical Trial Success: Ibezapolstat demonstrated a 96% clinical cure rate in Phase 2 trials, with no recurrence of infection, and is now ready for Phase 3 trials in the U.S. and EU, supported by positive regulatory feedback from the FDA and EMA.
Research Collaboration: Acurx's collaboration with Leiden University Medical Center has provided structural insights into ibezapolstat's mechanism of action, aiding the development of new antibiotics against multi-drug-resistant pathogens.
Microbiome Preservation: Ibezapolstat treatment appears to maintain a healthy gut microbiome, showing favorable changes in bile acid metabolism that may reduce the likelihood of C. difficile recurrence compared to traditional treatments like vancomycin.
Acurx Announces New Data on its DNA pol IIIC Inhibitor Antibiotics Demonstrating a Potential Class Effect of Gut Microbiome Selectivity Presented at IDWeek 2025 Scientific Conference
Ibezapolstat's Unique Properties: Acurx Pharmaceuticals' ibezapolstat (IBZ) shows selective antibacterial activity in the gut, preserving beneficial bacteria and contributing to its effectiveness against C. difficile infection (CDI) without increasing the risk of recurrence.
Clinical Trial Success: The Phase 2 clinical trials demonstrated a 96% clinical cure rate for ibezapolstat in CDI patients, with 100% of those cured remaining free of recurrence, indicating its potential superiority over traditional treatments like vancomycin.
Microbiome-Sparing Effects: New data suggest that ibezapolstat may have a microbiome-sparing class effect, which is crucial for maintaining gut health and preventing CDI recurrence, a significant concern with existing antibiotics.
Regulatory Progress and Future Trials: Ibezapolstat has received FDA QIDP and Fast-Track Designations, and Acurx is preparing to initiate international Phase 3 trials, aiming to establish its efficacy and safety for broader use against Gram-positive bacterial infections.
