Legal Scrutiny Clouds Galectin Therapeutics’ Clinical Progress

The biotechnology firm Galectin Therapeutics is now the subject of inquiries launched by multiple U.S. law firms. These investigations focus on potential securities law violations tied to corporate communications regarding its lead drug candidate, Belapectin. This legal development follows a steep share price decline of more than 28% that occurred just before the end of the year.

Amidst the growing legal uncertainty, the company has moved to shore up its financial position. Executive Chairman Richard E. Uphsein has provided an unsecured, convertible credit facility worth $10 million. Management states that, combined with the extension of existing credit facilities through June 2027, this capital should fund operations until at least March 2027.

This financial maneuvering exists alongside recent clinical data. In November 2025, Galectin presented results from its NAVIGATE trial (Phase 2b/3) at a scientific conference. The data suggested a specific dosage of Belapectin—a galectin-3 inhibitor for MASH cirrhosis—could slow the progression of liver stiffness and reduce the occurrence of new varices in high-risk patients. For instance, the incidence of new esophageal varices in one patient subgroup reportedly fell from 42.9% to 22.7%.

The FDA Update That Triggered a Sell-Off

The legal probes, initiated by firms including Levi & Korsinsky and the Pomerantz Law Firm, center on whether the company misled investors about Belapectin's regulatory progress. The trigger was a corporate announcement on December 19, 2025, concerning a response from the U.S. Food and Drug Administration (FDA) to a Type C meeting request.

Should investors sell immediately? Or is it worth buying Galectin Therapeutics?

While Galectin stated it had reached a preliminary agreement with the regulator on the patient population for a planned registrational study, the market reaction was sharply negative. Shares sold off heavily on the day of the release. The plaintiff attorneys are examining whether the company's communications adequately disclosed the risks or full content of the FDA's feedback. A key question for investors is whether ambiguity around the final study design will lead to a lasting erosion of confidence.

Path Forward with Regulators and Courts

Galectin has scheduled a follow-up meeting with the FDA to finalize remaining aspects of the design for the planned approval study. The company intends to present new biomarker data during these discussions to further support Belapectin's efficacy profile.

The near-term trajectory for the stock is likely to be dictated by two parallel outcomes: the conclusions from this critical regulatory meeting and the findings of the ongoing legal investigations. The interplay between clinical promise and legal challenge now defines the investment narrative for Galectin Therapeutics.

• Lead Candidate: Belapectin, a galectin-3 inhibitor targeting MASH cirrhosis.
• Legal Status: Investigations underway by law firms including Levi & Korsinsky and Pomerantz.
• Trial Data: The NAVIGATE study indicated antifibrotic effects in November 2025.
• Financial Runway: A $10 million USD credit facility supports operations through March 2027.
• Regulatory Status: Preliminary alignment with FDA on patient group for registrational study; study design details pending.