Passage Bio disclosed it will cut about 75% of its workforce after the FDA rejected its planned registrational trial design for its lead gene therapy candidate PBFT02 in frontotemporal dementia with granulin mutations. The company said the FDA required a randomized controlled trial rather than a single-arm approach following a Type C meeting outcome. Alongside the workforce reduction, Passage launched a strategic review and said it is evaluating potential next steps for the PBFT02 program and the company. Passage reported early Phase 1/2 upliFT-D data suggesting possible slowing of neurodegeneration, including changes in brain atrophy and plasma neurofilament levels. For gene therapy developers, the update highlights how trial design can become a gating factor for registrational progress—and how quickly companies may pivot from clinical execution to asset-level strategy after regulatory feedback.