Longeveron held a Type C meeting with the FDA in late March 2026 regarding the ELPIS II Phase 2b trial for HLHS. The FDA determined that the current primary endpoint, right ventricle ejection fraction (RVEF), is not appropriate to demonstrate efficacy. The FDA no longer classifies the ELPIS II trial as a pivotal study. The FDA cannot agree on a new primary endpoint while the trial is ongoing due to the blinded nature of the NIH-mandated interim analysis. Top-line results for the 40-patient trial are still expected in August 2026. The company plans to submit a new Statistical Analysis Plan (SAP) focusing on objective measures like mortality and cardiac events.