Longeveron’s infant heart-disease trial misses its primary endpoint

Longeveron ($LGVN) said its ELPIS II Phase 2b study in infants with hypoplastic left heart syndrome failed to meet its primary endpoint. The 40-patient trial assessed right-ventricular function after 12 months. The reported treatment difference was negative 0.7 percentage points, with a p-value of 0.8336, providing no statistically significant evidence of benefit on the primary measure.

Exploratory outcomes also failed to establish statistically significant improvements, although the company reported no new safety signals. Longeveron plans further analysis and discussions with the FDA while pursuing cost-containment measures and evaluating strategic options. The absence of a new safety concern does not offset the missed efficacy endpoint. The announcement creates uncertainty around the program’s development path rather than confirming that another trial or an approval submission will proceed.

Sources:

• Longeveron — ELPIS II topline results, company release reprint