secwatch.observer — SEC 8-K summary
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Issuer:     Passage BIO, Inc. (PASG)
CIK:        0001787297
Form:       8-K
Filed at:   2024-07-16T23:59:59+00:00
Accession:  0001558370-24-009826
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Passage Bio gets FDA green light to add FTD-C9orf72 arm to PBFT02 trial
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- Positive Type C meeting feedback from FDA supports evaluating PBFT02 in FTD-C9orf72 patients.
- Passage Bio to amend upliFT-D Phase 1/2 global study protocol to include FTD-C9orf72 population.
- Company plans to initiate dosing of FTD-C9orf72 patients in first half of 2025.
- FTD-C9orf72 affects an estimated 21,000 individuals in the U.S. and Europe.
- PBFT02 already has FDA Fast Track and Orphan Drug designations; also Orphan from European Commission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1787297/000155837024009826/0001558370-24-009826-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1787297/000155837024009826/pasg-20240716x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-24-009826

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