PBFT02 cuts brain atrophy 64% vs natural history; FDA demands randomized trial; strategic review begun

Passage BIO, Inc.

PBFT02 patients with global CDR 1 at baseline showed 64% less whole brain atrophy (3.1% vs 8.7%) at 12 months vs ALLFTD natural history.
FDA Type C meeting indicated a randomized controlled registrational trial is required for PBFT02 in FTD-GRN.
Company initiated a review of strategic alternatives including merger, sale, or licensing; engaged Wedbush PacGrow as advisor.
No new treatment-related SAEs; prior asymptomatic SAEs (venous sinus thrombosis, hepatotoxicity) remain unchanged.
Plasma NfL stabilized at 12 months (average -1.0 pg/mL) vs +13.5 pg/mL in untreated natural history patients.

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