Passage Bio launched a strategic review and disclosed plans to cut roughly 75% of its workforce after the FDA signaled it would not accept a single-arm registrational trial design for PBFT02 in FTD-GRN. The company said the agency required a randomized controlled trial following a Type C meeting outcome. Passage said it expects severance and exit costs around $3.3 million and expects the workforce reduction to be mostly completed in the second and third quarters. It also disclosed that it is evaluating options including a merger or acquisition and sale of assets or licensing opportunities. Despite the regulatory roadblock, Passage pointed to ongoing Phase 1/2 upliFT-D data suggesting potential slowing of neurodegeneration, including improvements in brain atrophy and plasma neurofilament biomarkers.
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