London
16 °C
Manchester
Glasgow
20 °C
Dublin
Belfast
Washington
Denver
Atlanta
Dallas
33 °C
Houston Texas
31 °C
New Orleans
El Paso
Phoenix
Los Angeles
20 °C
29 °C
16 °C
21 °C
29 °C
Acurx Pharmaceuticals (NASDAQ: ACXP) Highlights FDA's New CDI Guidance That Could Accelerate Approval Path for Ibezapolstat
Acurx Pharmaceuticals (NASDAQ: ACXP) Highlights FDA's New CDI Guidance That Could Accelerate Approval Path for Ibezapolstat
NEW YORK CITY, NY / ACCESS Newswire / May 19, 2026 / New to The Street's longtime featured biotechnology client, Acurx Pharmaceuticals, Inc. (Nasdaq:ACXP), highlighted a potentially transformative regulatory development for companies developing therapies targeting Clostridioides difficile infection (CDI), as the U.S. Food and Drug Administration finalized updated guidance that may significantly streamline the path toward approval for new CDI antibiotics.
The FDA's newly finalized guidance, titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention," outlines updated recommendations for the clinical development of CDI therapies. Most notably, the guidance indicates that under certain circumstances, FDA approval may now be supported by a single pivotal clinical trial combined with confirmatory evidence, representing a major shift from the traditional requirement of two successful Phase 3 studies.
The finalized guidance has the potential to accelerate development timelines and reduce the complexity of bringing urgently needed new antibiotic therapies to market for patients suffering from CDI, a serious bacterial infection that remains a major healthcare challenge globally.
Acurx Pharmaceuticals is currently advancing ibezapolstat, its first-in-class DNA polymerase IIIC inhibitor antibiotic candidate for the treatment of CDI. The company's program is considered Phase 3-ready, with prior alignment discussions already completed with the European Medicines Agency (EMA).
The updated FDA guidance may further support the company's efforts to efficiently advance ibezapolstat through the regulatory pathway as Acurx continues engaging with regulators regarding its pivotal development strategy.
Acurx Pharmaceuticals continues to position itself as an innovative leader in antimicrobial resistance (AMR) and next-generation antibiotic development, targeting one of the most challenging infection categories facing healthcare systems worldwide.
New to The Street has featured Acurx Pharmaceuticals across its sponsored programming television broadcasts on Bloomberg Television and Fox Business, digital media platforms, earned media distribution, and outdoor billboard campaigns as part of its ongoing long-form executive media partnership.
To learn more about Acurx Pharmaceuticals and ibezapolstat, visit:
Acurx Pharmaceuticals Website
About New to The Street
New to The Street is one of the longest-running U.S. and international sponsored television brands, broadcasting as sponsored programming on Bloomberg Television and Fox Business. The platform features public and private companies through long-form interviews, earned media, commercial campaigns, outdoor billboard advertising, and one of the largest financial television YouTube channels in the world with over 4.7 million subscribers.
About NewsOut
NewsOut is a next-generation media and video press release platform combining television-style production, executive storytelling, social distribution, and digital amplification to help public and private companies increase visibility across financial media, YouTube, and investor-focused audiences worldwide. The NewsOut YouTube Channel has surpassed 854,000 subscribers and continues to rapidly expand its reach across investor, business, and financial audiences globally.
Contact: Monica Brennan [email protected]
SOURCE: New to The Street
View the original press release on ACCESS Newswire
(P.Clark--TAG)
