Longeveron announced a constructive Type C FDA meeting on ELPIS II trial for HLHS, where FDA rejected RVEF as primary endpoint and no longer deems it pivotal, but agreed to future meeting post top-line results in August 2026.
Key takeaways
FDA held Type C meeting in late March 2026, summary in late April, acknowledging HLHS unmet need but rejecting RVEF primary endpoint.
FDA will not agree new primary endpoint during ongoing trial due to NIH interim analysis; no longer calls ELPIS II pivotal.
FDA agreed to meet again after ELPIS II completion to discuss results and path forward.
FDA favors objective measures like all-cause mortality, transplant-free survival, transplantation events, MACE, all captured in trial.
Company plans Sponsor SAP submission with composite primary endpoint; optimistic for BLA filing post-August 2026 top-line data.