Longeveron Reports FDA Type C Meeting On Laromestrocel In HLHS; Agency Rejects RVEF Endpoint, Requests Hard Clinical Outcomes, ELPIS II Phase 2b Top-Line Data Expected August 2026 With Potential BLA Path Discussed Post-Readout; FDA No Longer Refer...

Longeveron

Longeveron

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The Company intends to submit to the FDA a Sponsor Statistical Analysis Plan (SAP) for ELPIS II with a composite primary endpoint and secondary endpoints for the FDA's review and approval, and remains optimistic that the trial results and other available evidence will be sufficient to support filing a Biologics License Application (BLA) following the readout of top-line results of the ELPIS II data.

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