---
title: "Galectin, FDA agree on late-stage trial design for MASH therapy"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/290567199.md"
description: "Galectin Therapeutics (GALT) announced an agreement with the FDA on the design and primary endpoint for a Phase 3 trial of belapectin for MASH-related cirrhosis. This follows the failure of its NAVIGATE Phase 2b/3 trial in 2024. Despite the regulatory progress, GALT shares fell ~9% premarket. The company expects the new study to be comparable in size to NAVIGATE, with a final protocol submission anticipated in Q3 2026."
datetime: "2026-06-23T13:00:40.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/290567199.md)
  - [en](https://longbridge.com/en/news/290567199.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/290567199.md)
---

# Galectin, FDA agree on late-stage trial design for MASH therapy


### Related Stocks

- [GALT.US](https://longbridge.com/en/quote/GALT.US.md)

## Related News & Research

- [Galectin chair Uihlein receives 34,376,167 shares in debt-to-equity conversion](https://longbridge.com/en/news/294818966.md)
- [Galectin Therapeutics posts corporate presentation highlighting belapectin program for MASH cirrhosis, portal hypertension](https://longbridge.com/en/news/292638312.md)
- [Can-Fite says Phase III namodenoson trial in advanced liver cancer advances under FDA, EMA guidance](https://longbridge.com/en/news/295654944.md)
- [Belite Bio wins FDA Priority Review for tinlarebant in Stargardt disease NDA](https://longbridge.com/en/news/295572924.md)
- [Datasea registers, lists NeuroVibe biofeedback system with FDA as Class II 510(k)-exempt device](https://longbridge.com/en/news/295541382.md)