Immuron Limited Announces Planned IND Submission to FDA for IMM-529 Targeting C. difficile Infection, Paving Way for Phase 2 Clinical Trials

Immuron Limited Updates Regulatory Progress on Key Projects MELBOURNE, Australia - Immuron Limited (ASX: IMC; NASDAQ: IMRN), a global biopharmaceutical company, has announced significant progress in its regulatory pipeline. The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its candidate IMM-529, targeting Clostridioides difficile infection, in mid-October 2025. Approval of this IND will enable Immuron to initiate a Phase 2 clinical program. Additionally, initial pre-clinical research studies for IMM-986, aimed at treating Vancomycin-resistant Enterococci (VRE), are on track for completion by year-end 2025. Immuron also confirmed that its Travelan® product, currently imported into the U.S. as a dietary supplement, is not affected by new U.S. pharmaceutical tariffs. No new grant or funding has been announced, and the updates relate solely to Immuron Limited’s own regulatory progress. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immuron Limited published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9539019-en) on October 02, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)