other material
confidence high
sentiment positive
materiality 0.75
Passage Bio gets FDA green light to add FTD-C9orf72 arm to PBFT02 trial
Passage BIO, Inc.
- 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.