secwatch.observer — SEC 8-K summary
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Issuer:     Passage BIO, Inc. (PASG)
CIK:        0001787297
Form:       8-K
Filed at:   2026-04-20T23:59:59+00:00
Accession:  0001104659-26-045219
Event type: other_material
Sentiment:  negative
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1787297/000110465926045219/0001104659-26-045219-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1787297/000110465926045219/tm2612152d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-045219

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer