Passage Bio said it is launching a strategic review and reducing headcount by about 75% after the FDA did not support a single-arm registrational trial design for its lead program in frontotemporal dementia with granulin mutations. Following the company’s April FDA Type C meeting, Passage said the agency required a randomized controlled trial design for PBFT02. The company is simultaneously evaluating next steps, including potential strategic alternatives such as a merger or acquisition, asset sales, or licensing. Passage also disclosed that it expects most of the workforce reduction to be completed in the second and third quarters, with severance and exit costs estimated around $3.3 million. As context, the biotech reported Phase 1/2 upliFT-D data suggesting slower neurodegeneration and biomarker changes, including brain atrophy and plasma neurofilament levels. The update underscores how FDA trial-design expectations can quickly reshape capital allocation at pre-commercial gene therapy companies.