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Galectin Therapeutics (GALT) FDA Events

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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.

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

  • 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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