---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-053902"
form_type: "8-K"
ticker: "LGVN"
cik: "0001721484"
company_name: "Longeveron Inc."
filed_at: "2026-05-08T23:59:59+00:00"
generated_at: "2026-05-14T21:08:48.353509+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-26-053902
- form_type: 8-K
- ticker: LGVN
- cik: 0001721484
- company_name: Longeveron Inc.
- filed_at: 2026-05-08T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1721484/000121390026053902/0001213900-26-053902-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1721484/000121390026053902/ea0289853-8k_longeveron.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-053902
- JSON: https://secwatch.observer/filing/0001213900-26-053902.json
- Plain text: https://secwatch.observer/filing/0001213900-26-053902.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.