---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-061942"
form_type: "8-K"
ticker: "LGVN"
cik: "0001721484"
company_name: "Longeveron Inc."
filed_at: "2024-07-17T23:59:59+00:00"
generated_at: "2026-05-31T20:14:55.157802+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Longeveron receives FDA Fast Track designation for Lomecel-B in mild Alzheimer's

## Summary
- FDA Fast Track designation granted for Lomecel-B (allogeneic cell therapy) to treat mild Alzheimer’s disease.
- Second FDA special designation for Lomecel-B in Alzheimer's, following RMAT designation on July 9, 2024.
- Fast Track enables Priority Review (6-month review) and rolling submission; fifth overall special designation.
- Phase 2a CLEAR MIND data showed overall slowing/prevention of disease worsening versus placebo.
- Full results to be presented at AAIC 2024 (July 28–Aug 1) in Featured Research Session and poster.

## SEC filing metadata
- accession: 0001213900-24-061942
- form_type: 8-K
- ticker: LGVN
- cik: 0001721484
- company_name: Longeveron Inc.
- filed_at: 2024-07-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1721484/000121390024061942/0001213900-24-061942-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1721484/000121390024061942/ea0209541-8k_longeveron.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-061942
- JSON: https://secwatch.observer/filing/0001213900-24-061942.json
- Plain text: https://secwatch.observer/filing/0001213900-24-061942.txt

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