Laromestrocel (lomecel-B) - (ELPIS II)

August 12, 2026: Longeveron Inc. (NASDAQ: LGVN) said laromestrocel’s next key catalyst is September 2026 topline data from the Phase 2b ELPIS II trial in hypoplastic left heart syndrome (HLHS). The company said FDA held a Type C meeting in late March 2026 on ELPIS II and the upcoming readout, and the trial’s independent DMC completed its final prespecified review with no safety concerns and recommended the study continue to completion. Laromestrocel has Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS.

Other program updates: Pediatric dilated cardiomyopathy (PDCM) — the IND became effective in July 2025, allowing a single Phase 2 registrational trial; trial initiation is anticipated in 2027, with planning beginning in 2026. Alzheimer’s disease — additional Phase 2a mild AD data were presented at AAIC 2026 indicating reduced neuroinflammation; CLEAR MIND Phase 2a results were published in Nature Medicine in March 2025. The company also reported a March 2025 Type B FDA meeting with tentative alignment on a single Phase 2/3 trial that, if positive, could support a BLA. Aging-related frailty — Phase 2b data published in Cell Stem Cell in February 2026 indicated improved physical condition after nine months versus placebo. Longeveron was also named an XPRIZE Healthspan finalist and received a $1.0 million Milestone 2 award.