Passage Bio disclosed a strategic review alongside layoffs after FDA feedback shifted the design requirements for its lead gene therapy in frontotemporal dementia with granulin mutations. Following a Type C meeting outcome, the company said the FDA would require a randomized controlled trial rather than a single-arm design. The company plans to cut about 75% of its workforce, projecting severance and exit costs of about $3.3 million, while continuing to evaluate licensing, asset sale, or merger options to maximize shareholder value. Passage also highlighted ongoing Phase 1/2 upliFT-D data suggesting biomarker improvements including brain atrophy and plasma neurofilament levels.