Regeneus Ltd. ( (AU:CMB) ) has shared an announcement.
Cambium Bio Limited announced that the U.S. FDA has approved its potency assay strategy for Elate Ocular® Phase 3 clinical trials. This regulatory milestone allows the company to finalize assay validation with its manufacturing partner, keeping them on track to start registration-enabling Phase 3 trials for moderate to severe dry eye disease in mid-2025. The FDA’s agreement highlights the robustness of Cambium Bio’s Chemistry, Manufacturing, and Controls (CMC) and analytical development approach, potentially enhancing its industry positioning and stakeholder confidence.
More about Regeneus Ltd.
Cambium Bio Limited is a Sydney-based clinical-stage regenerative medicine company that focuses on developing innovative biologics for ophthalmology and tissue repair applications. The company leverages its proprietary human platelet lysate technology to create a pipeline of novel therapeutics, with a primary focus on ophthalmology, including its lead product candidate, Elate Ocular®, for treating dry eye disease. Additionally, Cambium Bio is developing therapies for knee osteoarthritis and other tissue repair indications using its stem cell platform, Progenza™.
YTD Price Performance: -12.50%
Average Trading Volume: 24,137
Technical Sentiment Consensus Rating: Buy
Current Market Cap: A$4.95M
See more insights into CMB stock on TipRanks’ Stock Analysis page.