secwatch.observer — SEC 8-K summary
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Issuer:     Passage BIO, Inc. (PASG)
CIK:        0001787297
Form:       8-K
Filed at:   2023-12-20T23:59:59+00:00
Accession:  0001104659-23-127507
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Passage Bio reports promising Phase 1/2 data for PBFT02 in FTD-GRN; shifts strategy to adult neurodegenerative diseases
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- Dose 1 of PBFT02 achieved 3.6-6.6-fold increase in CSF PGRN at day 30, reaching supraphysiologic levels of 10.7-17.3 ng/mL.
- PBFT02 was generally well-tolerated with enhanced steroid regimen; no serious AEs in patients 2 and 3.
- Company to focus on PBFT02 in FTD-GRN, FTD-C9orf72, ALS, and Alzheimer's; seeking partnerships for pediatric programs.
- Expects to initiate dosing of Cohort 2 in 1H 2024 and report full 6-month data from Cohort 1 in 2H 2024.
- Estimates FTD-GRN prevalence at ~18,000 patients in US and Europe; exploring PBFT02 in larger indications.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1787297/000110465923127507/0001104659-23-127507-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1787297/000110465923127507/tm2332555d3_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-127507

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