Longeveron Inc. held a Type C meeting with the U.S. Food and Drug Administration in late March 2026, with the FDA issuing a meeting summary in late April 2026, the company reported.
The session addressed the Phase 2b ELPIS II trial of laromestrocel (Lomecel-B) as an adjunct therapy for infants with Hypoplastic Left Heart Syndrome. The FDA acknowledged HLHS as a rare disease with unmet need but said the trial’s current primary endpoint, right ventricle ejection fraction, is insufficient to demonstrate efficacy.
Because ELPIS II remains blinded and an NIH-mandated interim analysis is underway, the agency and Longeveron could not agree on a new primary endpoint at this time, and the FDA no longer considers ELPIS II pivotal, a change from its 2024 position.
The FDA recommended objective outcomes such as all-cause mortality, cardiac transplant-free survival, incidence of cardiac transplantation and major adverse cardiac events; Longeveron is collecting these measures and plans to submit a Sponsor Statistical Analysis Plan with a composite primary endpoint for FDA review.
The HLHS program holds Orphan Drug, Fast Track and Rare Pediatric Disease designations and notes top-line ELPIS II results are expected in August 2026.
