Immuron

IMRN

Market cap $10.5M

Key Points Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed FDA 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.

New York, New York--(Newsfile Corp. - October 17, 2025) - Emerging Growth Research today announced the initiation of coverage on Immuron Limited (Nasdaq: IMRN) with a Buy-Extended rating and a 12-month price target of $4.00, representing over 80% upside from the Company's recent closing price of $2.20. The initiation report highlights Immuron's proprietary polyclonal antibody platform, strong revenue growth from its over-the-counter product Travelan®, and an expanding clinical pipeline addressing major global infectious diseases.

Sales Highlights (unaudited): Global • Q1 sales AUD$2.0 million up 34% on prior comparative period (pcp)       Australia • Q1 sales AUD$1.6 million up 52% on pcp       Canada • Q1 sales AUD$0.0 million down 92% on pcp       USA • Q1 sales AUD$0.4 million up 44% on pcp MELBOURNE, Australia, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce continued sales growth (unaudited) of Travelan®, an over-the-counter immune supplement that targets pathogenic bacteria and the toxins they produce in the gastrointestinal (GI) tract. Continued growth ( +34% on pcp) in Australia can be contributed to: (1) increased awareness and consideration driven by extensive digital and social media marketing.

Key Points Immuron submits Investigational new drug (IND) application to FDA for clinical 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 MELBOURNE, Australia, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for clinical development of IMM-529. Under this new IND, Immuron is proposing the development of IMM-529 for treatment of Clostridioides difficile (C.

Highlights: US Tariffs: Immuron does not anticipate any material impact from the recently announced US tariffs on pharmaceutical products Travelan® Clinical Study: Topline results from the Travelan® clinical study conducted by Uniformed Services University are anticipated in October 2025 IMM-529 Regulatory Milestone: Immuron plans to submit an Investigational New Drug (IND) application to the U.S. FDA for IMM-529 (Clostridiodes difficile infection) in mid-October 2025 ProIBS® Commercial Launch: The Australian Launch of ProIBS® is on track for Q4 of calendar year 2025 IMM-986 Pre-Clinical Progress: Initial pre-clinical research studies for IMM-986, targeting Vancomycin-resistant Enterococci (VRE), are anticipated to be completed by year-end 2025 MELBOURNE, Australia, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to provide shareholders with a brief update on progress with a number of projects. Sales As announced on July 17, Immuron achieved record sales up to Financial Year ending June 30, 2025.Immuron is on track to exceed FY24 first quarter sales.

MELBOURNE, Australia, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN) advises it has entered into a partnership with InvestorHub, a direct-to-investor engagement software company that provides public companies the digital capabilities to build direct and interactive relationships with investors.

Sales Highlights (unaudited): Global Annual sales AUD$7.3 million up 49% on prior year June 2025 Quarter AUD$2.0 million up 55% on prior year Australia Annual sales AUD$5.2 million up 40% on prior year June 2025 Quarter AUD$1.5 million up 58% on prior year North America Annual sales AUD$2.0 million up 76% on prior year June 2025 Quarter AUD$0.5 million up 49% on prior year MELBOURNE, Australia, July 17, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce continued sales growth (unaudited) of Travelan®, an over-the-counter immune supplement that targets pathogenic bacteria and the toxins they produce in the gastrointestinal (GI) tract. Flavio Palumbo, Chief Commercial Officer, said, “Immuron has exceeded sales projections and achieved record FY25 sales of A$7.3 million, with growth just shy of 50% on last year.

Highlights: Immuron on track to exceed A$7 million in Sales this financial year Uniformed Services University anticipates topline results of Travelan® clinical study in October 2025 Immuron anticipates IMM-529 (Clostridiodes difficile infection) IND submission to the FDA in August 2025 Launch plans underway for ProIBS® in Australia Immuron anticipates IMM-986 (Vancomycin-resistant enterococci) pre-clinical research results in August 2025 MELBOURNE, Australia, May 30, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to provide shareholders with a brief update on progress with a number of projects. Sales As announced on April 10, Immuron achieved record sales up to the end of March for the current Financial Year.

Sales Highlights (unaudited): Global Immuron exceeds AUD$5 million in sales in a fiscal year - highest sales in history March 2025 Quarter AUD$1.3 million up 2% on prior year March 2025 Year to Date AUD$5.3 million up 46% on prior year Australia March 2025 Quarter AUD$0.8 million down 8% on prior year March 2025 Year to Date AUD$3.7 million up 34% on prior year North America March 2025 Quarter AUD$0.5 million up 28% on prior year March 2025 Year to Date AUD$1.6 million up 86% on prior year MELBOURNE, Australia, April 10, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce continued sales growth (unaudited) of Travelan®, an over-the-counter immune supplement that targets pathogenic bacteria and the toxins they produce in the gastrointestinal (GI) tract. Flavio Palumbo, Chief Commercial Officer said, “For the first time, Immuron has exceeded A$5 million in sales - our highest fiscal year sales ever!

MELBOURNE, Australia, March 05, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce it has entered into an exclusive distribution agreement for the territories of Australia and New Zealand. Immuron will launch ProIBS® for the treatment of symptoms related to IBS in the retail pharmacy sales channel. Immuron has been a leader in digestive health in Australia for many years. ProIBS® will join Immuron's product portfolio which includes the rapidly growing Travelan® brand building on the premium efficacy product range that will deliver better outcomes for consumers that Pharmacists will love to recommend.