---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-045219"
form_type: "8-K"
ticker: "PASG"
cik: "0001787297"
company_name: "Passage BIO, Inc."
filed_at: "2026-04-20T23:59:59+00:00"
generated_at: "2026-05-15T05:21:17.834322+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# PBFT02 cuts brain atrophy 64% vs natural history; FDA demands randomized trial; strategic review begun

## Summary
- PBFT02 patients with global CDR 1 at baseline showed 64% less whole brain atrophy (3.1% vs 8.7%) at 12 months vs ALLFTD natural history.
- FDA Type C meeting indicated a randomized controlled registrational trial is required for PBFT02 in FTD-GRN.
- Company initiated a review of strategic alternatives including merger, sale, or licensing; engaged Wedbush PacGrow as advisor.
- No new treatment-related SAEs; prior asymptomatic SAEs (venous sinus thrombosis, hepatotoxicity) remain unchanged.
- Plasma NfL stabilized at 12 months (average -1.0 pg/mL) vs +13.5 pg/mL in untreated natural history patients.

## SEC filing metadata
- accession: 0001104659-26-045219
- form_type: 8-K
- ticker: PASG
- cik: 0001787297
- company_name: Passage BIO, Inc.
- filed_at: 2026-04-20T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1787297/000110465926045219/0001104659-26-045219-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1787297/000110465926045219/tm2612152d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-045219
- JSON: https://secwatch.observer/filing/0001104659-26-045219.json
- Plain text: https://secwatch.observer/filing/0001104659-26-045219.txt

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