Longeveron FDA Type C meeting: ELPIS II trial no longer deemed pivotal; top-line data due Aug 2026

Longeveron Inc.

FDA stated RVEF is not an appropriate primary endpoint; no new endpoint can be agreed while trial blinded due to NIH interim analysis.
ELPIS II is no longer referred to as pivotal by FDA, reversing prior 2024 discussion.
FDA willing to meet after trial completion; objective measures (mortality, transplant, MACE) could support efficacy.
Company will submit a Sponsor Statistical Analysis Plan with composite primary endpoint for FDA review.
Top-line Phase 2b results for laromestrocel in HLHS still expected in August 2026.

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