Clinical Trial ProgressThe ELPIS II trial of laromestrocel has achieved over 90% enrollment and, if positive, could facilitate a Biologics License Application submission.
Financial PerformanceTop-line revenue exceeded expectations, driven by higher participant demand and the addition of a third-party manufacturing services contract.
Regulatory AdvancesThe FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designation for the treatment of mild Alzheimer's disease, allowing greater access to FDA interaction during development.