Immuron IMM-529 IND approved by FDA
Immuron Limited - American Depositary Shares (IMRN)
US:NASDAQ Investor Relations:
immuron.com/investor-centre/business-overview
Company Research
Source: GlobeNewswire
Key Points Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceedFDA assigned an IND number (032095) for the IMM-529 application IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now active MELBOURNE, Australia, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that the United States Food and Drug Administration (FDA) has approved Immuron’s Investigational New Drug application for IMM-529 and the Phase 2 clinical trial may proceed. The Company plans to initiate a Phase 2 clinical trial for IMM-529 in individuals with Clostridioides difficile infection (CDI) during the first half of 2026. The Phase 2 clinical trial will be a randomized, double blind, placebo-controlled clinical study of IMM-529
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News
- Immuron New U.S. Department of Defense Award & Clinical Trial UpdateGlobeNewswire
- Immuron Announces Clinical Trial UpdateGlobeNewswire
- Presenting on Emerging Growth Conference 87 Day 1 on October 22. Register to live stream.GlobeNewswire
- Immuron Q1 FY26 YoY growth [Yahoo! Finance]Yahoo! Finance
- Immuron Q1 FY26 YoY growthGlobeNewswire
IMRN
Sec Filings
- 12/5/25 - Form 6-K
- 12/4/25 - Form 6-K
- 12/4/25 - Form 6-K
- IMRN's page on the SEC website