
Passage Bio reports biomarker improvements, FDA says randomized registrational trial required

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Passage Bio reported interim data from its upliFT-D study, showing significant reductions in brain atrophy and stabilization of plasma NfL levels with PBFT02. CDR-1 patients experienced a 64% reduction in whole brain atrophy and a 54% reduction in frontotemporal atrophy at 12 months. The FDA indicated that a randomized controlled registrational study is necessary, prompting the company to evaluate next steps and engage in a strategic review with Wedbush PacGrow.
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