secwatch.observer — SEC 8-K summary
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Issuer:     Passage BIO, Inc. (PASG)
CIK:        0001787297
Form:       8-K
Filed at:   2022-12-14T23:59:59+00:00
Accession:  0001558370-22-018617
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Passage Bio reports positive interim Phase 1/2 data for PBGM01 in GM1 gangliosidosis
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- No treatment-related SAEs; all AEs mild-moderate; no DRG toxicity or ICM administration complications.
- Dose-dependent CSF β-Gal activity increases (up to 5.2-fold) and GM1 ganglioside decreases (up to 75%) in high-dose cohort.
- Patients with milder baseline developmental delay showed meaningful improvement on Vineland and Bayley scales.
- Cohort 4 fully dosed; data expected by mid-2023; conference call held December 14, 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1787297/000155837022018617/0001558370-22-018617-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1787297/000155837022018617/pasg-20221214x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-22-018617

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