Galectin Therapeutics Inc GALT
Galectin Therapeutics Inc (Nasdaq: GALT) is a GI/hepatology drug developer. Its lead program, belapectin (GR-MD-02), is in Phase 2 for NASH cirrhosis / portal hypertension.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| belapectin | NASH cirrhosis (NAVIGATE Phase 2b/3, complete) | protein/peptide | Phase 2 |
| belapectin + pembrolizumab | Head and neck SCC | protein/peptide | Phase 2 |
Recent results and decisions
- Jun 23, 2026positive Positive FDA Type C meeting: agreement on composite liver outcome primary endpoint (incl. large varices), blinded central endoscopy review and a single 2 mg dose for the planned Phase 3.
Galectin has reached agreement with the FDA on the primary endpoint and regulatory path forward for the potential full approval of belapectin
Filing - Dec 3, 2025positive NAVIGATE biomarker analyses: in patients with ELF >11.3, new varices occurred in 22.7% on belapectin vs 42.9% on placebo; PRO-C3 fell >50% from baseline; topline ITT was not statistically significant.
In these patients, the incidence of new varices was 22.7% with belapectin versus 42.9% with placebo—a meaningful difference in those at greatest risk of developing complications.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 GI/hepatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.