---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-070935"
form_type: "8-K"
ticker: "LXEO"
cik: "0001907108"
company_name: "Lexeo Therapeutics, Inc."
filed_at: "2023-12-18T23:59:59+00:00"
generated_at: "2026-06-07T11:29:32.664820+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Lexeo receives FDA Fast Track and Orphan Drug designations for gene therapy LX2020 in PKP2-ACM

## Summary
- FDA granted Fast Track and Orphan Drug designations for LX2020, an AAVrh10 gene therapy for PKP2-ACM.
- No approved treatments exist for PKP2-ACM, a prevalent genetic cardiovascular disease.
- LX2020 delivers a functional PKP2 gene intravenously to cardiac muscle as a one-time infusion.
- Planned Phase 1/2 HEROIC-PKP2 trial: 52-week, open-label, dose-escalating, multicenter with two cohorts (2.0x10^13 and 6.0x10^13 vg/kg).
- Orphan Drug offers market exclusivity and tax credits; Fast Track enables expedited FDA review.

## SEC filing metadata
- accession: 0000950170-23-070935
- form_type: 8-K
- ticker: LXEO
- cik: 0001907108
- company_name: Lexeo Therapeutics, Inc.
- filed_at: 2023-12-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1907108/000095017023070935/0000950170-23-070935-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1907108/000095017023070935/lxeo-20231218.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-070935
- JSON: https://secwatch.observer/filing/0000950170-23-070935.json
- Plain text: https://secwatch.observer/filing/0000950170-23-070935.txt

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