---
title: "Passage Bio reports biomarker improvements, FDA says randomized registrational trial required"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/283343631.md"
description: "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."
datetime: "2026-04-20T11:23:00.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/283343631.md)
  - [en](https://longbridge.com/en/news/283343631.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/283343631.md)
---

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

**Passage Bio reported updated upliFT-D interim data showing reduced brain atrophy and stabilized plasma NfL with PBFT02.**

**Key Highlights:**

-   PBFT02 CDR‑1 patients showed 3.1% whole brain atrophy at 12m vs 8.7% in ALLFTD NH (64% reduction; n=2 vs n=7).
-   PBFT02 CDR‑1 patients showed 4.6% frontotemporal atrophy at 12m vs 9.9% in ALLFTD NH (54% reduction; n=2 vs n=7).
-   Plasma NfL stabilized in treated patients: mean −1.0 pg/mL at 12m (n=6) vs +13.5 pg/mL in ALLFTD natural history (n=7).
-   Dose 1 (4.5e13 GC) produced durable CSF progranulin increases to mean 22.8 ng/mL at 12m (n=6) and 24.2 ng/mL at 18m (n=3); Dose 2 showed comparable levels by 6m.
-   FDA Type C meeting: agency indicated a randomized controlled registrational study will be required; company is evaluating next steps and initiated a strategic review with Wedbush PacGrow engaged.

Original SEC Filing: Passage BIO, Inc. \[ PASG \] - 8-K - Apr. 20, 2026

**Disclaimer**

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.

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