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Stock impact report

Immuron Plans Phase 2 Trial for IMM-529 following FDA review

Immuron Limited - American Depositary Shares (IMRN) 
Company Research Source: GlobeNewswire
Key Points Immuron completes pre-IND meeting with FDA on the development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI)Previous clinical trial data on IMM-529 provides support for continued development of IMM-529 Investigational new drug (IND) application for IMM-529 planned for 1H 2025 MELBOURNE, Australia, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has received favourable feedback from the United States Food and Drug Administration (FDA) on the pre-IND (investigational new drug) information package to support the clinical development of IMM-529. Following the FDA’s guidance and feedback, the Company now plans to file an investigational new drug (IND) application for IMM-529 to prevent or treat Clostridioides difficile infection (CDI) during the first half of 2025, followed by a Phase 2 trial of I Show less Read more
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