Longeveron says ELPIS II Phase 2b trial of laromestrocel in HLHS misses primary endpoint at 12 months
LGVN•Strategic review launched
Separately, the company launched a strategic review, citing cost controls and a focus on funding opportunities in longevity and aging-related frailty.
ELPIS II Phase 2b trial misses primary endpoint
Longeveron reported topline results from its ELPIS II Phase 2b trial of laromestrocel in infants with hypoplastic left heart syndrome.
The study missed its main efficacy goal, raising uncertainty over the program’s near-term regulatory path.
Safety remained consistent with prior experience, supporting continued analysis of secondary signals that could shape next steps.
Management plans to take the full dataset to the FDA to assess options for continuing development in HLHS.
