---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-232514"
form_type: "8-K"
ticker: "LXEO"
cik: "0001907108"
company_name: "Lexeo Therapeutics, Inc."
filed_at: "2025-10-07T23:59:59+00:00"
generated_at: "2026-05-17T04:29:32.421019+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Lexeo gets FDA feedback for LX2006 accelerated approval; interim data show LVMI reduction, mFARS improvement

## Summary
- FDA open to pooling ongoing Phase 1/2 data with pivotal study to support BLA for accelerated approval.
- Abnormal-LVMI patients (n=6): 18% mean reduction at 6 months, 23% at 12 months, exceeding 10% FDA threshold.
- All participants (n=16) >6-mo follow-up: 2.0-point mean mFARS improvement; 11 of 16 improved or stabilized.
- LX2006 generally well tolerated; no Grade 3+ SAEs; no discontinuations; one Grade 2 asymptomatic myocarditis.
- Lexeo plans to initiate LX2006 pivotal study as soon as possible in first half of 2026.

## SEC filing metadata
- accession: 0001193125-25-232514
- form_type: 8-K
- ticker: LXEO
- cik: 0001907108
- company_name: Lexeo Therapeutics, Inc.
- filed_at: 2025-10-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1907108/000119312525232514/0001193125-25-232514-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1907108/000119312525232514/lxeo-20251007.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-232514
- JSON: https://secwatch.observer/filing/0001193125-25-232514.json
- Plain text: https://secwatch.observer/filing/0001193125-25-232514.txt

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