FDA Events for Galectin Therapeutics (GALT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Galectin Therapeutics (GALT).
Over the past two years, Galectin Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Belapectin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Belapectin (Formerly GR-MD-02) - FDA Regulatory Timeline and Events
Belapectin (Formerly GR-MD-02) is a drug developed by Galectin Therapeutics for the following indication: Non-alcoholic steatohepatitis (NASH) with cirrhosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- December 20, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics, Inc. announced results from its global clinical trial NAVIGATE evaluating belapectin in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension.
AI Summary
Galectin Therapeutics, Inc. announced encouraging results from its global NAVIGATE trial that evaluated belapectin in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. The study was conducted at over 130 sites around the world. In the pre-specified per-protocol population, patients receiving belapectin at 2 mg/kg showed a 48.9% reduction in the development of esophageal varices compared to placebo (p < 0.05). Although the intent-to-treat population showed a favorable trend, the results did not reach statistical significance overall. Belapectin was well tolerated, with adverse event rates similar to those in the placebo group. Additional data, including results from a 36-month treatment period and further biomarker analysis, are expected to be shared in early 2025. These findings support further clinical development of belapectin as a promising treatment option for this challenging patient population.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- November 18, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
- Galectin Therapeutics, Inc. nnounced the presentation of three posters on the ongoing NAVIGATE trial in patients with MASH cirrhosis and portal hypertension at the American Association for the Study of Liver Diseases (AASLD)'s annual meeting 2024 Liver Meeting, being held November 15-19, 2024 in San Diego, California.
AI Summary
Galectin Therapeutics, Inc. announced that three posters presenting key data from its ongoing NAVIGATE trial will be featured at the AASLD 2024 Liver Meeting in San Diego, California, running from November 15-19, 2024. The NAVIGATE trial focuses on patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension, evaluating the potential of belapectin to prevent esophageal varices in this high-risk group.
The posters will highlight several important findings including the development of a centralized system for the consistent evaluation of esophageal and gastric varices, detailed baseline patient characteristics, and the discovery that about one-third of patients screened for the trial had esophageal varices. These results point to the need for reliable screening and targeted treatments in patients with MASH cirrhosis and portal hypertension, underscoring the trial’s significance in addressing this unmet medical need.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- April 9, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics, announced that Interim Phase 2b efficacy readout anticipated in Q4 2024
AI Summary
Galectin Therapeutics announced that the interim Phase 2b efficacy readout for its NAVIGATE study is expected in the fourth quarter of 2024. The NAVIGATE trial, which is evaluating belapectin in patients with metabolic dysfunction-associated steatohepatitis (MASH) liver cirrhosis, continues as planned following a positive recommendation from the Data and Safety Monitoring Board. This recommendation, based on unblinded data reviews, confirmed that the study can continue without modifications, further supporting belapectin’s favorable safety and tolerability. The trial is designed with an adaptive format that assesses the drug’s ability to prevent esophageal varices, a key marker of worsening portal hypertension. The upcoming interim analysis will be an important milestone in determining whether the study moves into its next phase and could provide essential evidence to support belapectin’s potential as a safe treatment option for liver cirrhosis associated with MASH.
Read Announcement- Drug:
- Belapectin (Formerly GR-MD-02)
- Announced Date:
- April 9, 2024
- Indication:
- Non-alcoholic steatohepatitis (NASH) with cirrhosis
Announcement
Galectin Therapeutics, reported the positive outcome of its fifth independent data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with cirrhotic portal hypertension caused by Metabolic Dysfunction-Associated SteatoHepatitis (MASH).
AI Summary
Galectin Therapeutics announced a positive outcome from its fifth independent DSMB meeting for the NAVIGATE study. This adaptive Phase 2b/3 trial is investigating belapectin’s effects in patients with cirrhotic portal hypertension caused by Metabolic Dysfunction-Associated SteatoHepatitis (MASH). After an unblinded review of emerging data, the DSMB recommended that the trial continue as planned, with no modifications. This decision supports the view that belapectin has a favorable safety and tolerability profile in patients who typically have several co-existing health issues.
The study uses a seamless, randomized, placebo-controlled, double-blind design to evaluate belapectin’s potential in preventing esophageal varices—an important marker of portal hypertension. An interim analysis on safety and efficacy is scheduled for the fourth quarter of 2024, marking a key milestone for this innovative clinical trial approach.
Read Announcement
Galectin Therapeutics FDA Events - Frequently Asked Questions
As of now, Galectin Therapeutics (GALT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Galectin Therapeutics (GALT) has reported FDA regulatory activity for Belapectin (Formerly GR-MD-02).
The most recent FDA-related event for Galectin Therapeutics occurred on December 20, 2024, involving Belapectin (Formerly GR-MD-02). The update was categorized as "Results," with the company reporting: "Galectin Therapeutics, Inc. announced results from its global clinical trial NAVIGATE evaluating belapectin in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension."
Currently, Galectin Therapeutics has one therapy (Belapectin (Formerly GR-MD-02)) targeting the following condition: Non-alcoholic steatohepatitis (NASH) with cirrhosis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:GALT) was last updated on 7/10/2025 by MarketBeat.com Staff
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