Clinical Trial MilestoneThe ELPIS II trial of laromestrocel has achieved over 90% enrollment and, if positive, could facilitate a Biologics License Application submission.
Market PositionLaromestrocel is expected to have an advantage due to an absence of the amyloid-related imaging abnormalities (ARIA) side-effects that have affected currently approved anti-amyloid drugs.
Regulatory ProgressThe FDA agreed to consider a Biologics License Application (BLA) based on positive interim trial results from the planned single study, which is considered a particularly positive sign.