Passage Bio disclosed a strategic review and planned workforce reduction after a Type C meeting with the FDA pushed the company away from a single-arm registrational design for PBFT02 in frontotemporal dementia with granulin mutations. The biotech said the FDA required a randomized controlled trial design, citing ethical, logistical, and financial challenges. The company said it expects to cut roughly 75% of its workforce, with severance and exit costs of about $3.3 million, and said it is evaluating next steps that could include a merger, acquisition, asset sale, or licensing opportunities. Passage Bio also pointed to early Phase 1/2 upliFT-D data suggesting PBFT02 may slow neurodegeneration, with improvements noted in brain atrophy and plasma neurofilament levels and sustained progranulin elevations. For gene therapy sponsors, the update illustrates how trial design decisions—sometimes finalized late in development—can force abrupt operating changes and re-parameterize timelines, budgets, and fundraising plans.