Cambium Bio’s Elate Ocular® Phase 3 Trials Approved by FDA

Regeneus Ltd. ( (AU:CMB) ) has shared an update.

Cambium Bio Limited announced that the FDA has approved the protocol for Phase 3 clinical trials of Elate Ocular®, a treatment for moderate to severe dry eye disease. This approval is a significant milestone, following the FDA Fast Track designation, and positions the company to advance Elate Ocular® through its final stages of clinical development. The trials will be conducted across multiple regions, including Australia and the United States, with the goal of meeting FDA requirements for a Biologics License Application. The company anticipates starting patient enrollment in mid-2025 and aims for a top-line data readout by mid-2026.

More about Regeneus Ltd.

Cambium Bio Limited (ASX:CMB) is a Sydney-based clinical-stage regenerative medicine company specializing in innovative biologics for ophthalmology and tissue repair applications. The company leverages proprietary technology based on human platelet lysate to develop novel therapeutics, with a primary focus on ophthalmology. Cambium Bio’s lead product candidate, Elate Ocular®, targets unmet medical needs in dry eye disease treatment, while its stem cell platform, Progenza™, is aimed at therapies for knee osteoarthritis and other tissue repair indications.

YTD Price Performance: -2.50%

Average Trading Volume: 11,618

Technical Sentiment Consensus Rating: Buy

Current Market Cap: A$5.52M

Learn more about CMB stock on TipRanks’ Stock Analysis page.