secwatch.observer — SEC 8-K summary
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Issuer:     Passage BIO, Inc. (PASG)
CIK:        0001787297
Form:       8-K
Filed at:   2025-06-23T23:59:59+00:00
Accession:  0001104659-25-061371
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PBFT02 Phase 1/2 data: durable PGRN boost; new pulmonary embolism SAE, protocol to add anticoagulation
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- Dose 1 PBFT02 increased CSF PGRN from <3 ng/mL to mean 25.9 ng/mL at 12 months (n=4); Dose 2 patient rose to 7.6 ng/mL at 1 month.
- Plasma NfL increased only 4% in treated patients vs expected 28-29% per year in natural history, suggesting slowed disease progression.
- Three of eight patients had four SAEs, including new pulmonary embolism in Dose 2 patient (Patient 8) possibly related; responded to anticoagulants.
- Company plans to amend upliFT-D protocol to add prophylactic low-dose anticoagulation and restrict enrollment to earlier-stage patients; Patient 9 may proceed with extra monitoring.
- Milestones: submit amendment July 2025; report Dose 2 interim data 1H 2026; seek regulatory feedback on registrational trial design 1H 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1787297/000110465925061371/0001104659-25-061371-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1787297/000110465925061371/tm2518584d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-061371

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