The Portnoy Law Firm announced an investigation into Galectin Therapeutics, Inc. (NASDAQ: GALT) for possible securities fraud, causing the company's stock to plummet 28.9% on December 19, 2025.
"Investors are encouraged to contact attorney Lesley F. Portnoy to discuss their legal rights," the law firm said in a statement, noting it may file a class action to recover investor losses.
The investigation follows a significant stock price collapse on December 19, 2025, when Galectin’s shares fell $1.78 to close at $4.38. The drop was a direct reaction to the company's disclosure that the U.S. Food and Drug Administration (FDA) had downgraded a meeting request for its lead drug candidate, belapectin, to a written response.
This procedural shift from a requested in-person or teleconference meeting signaled increased regulatory hurdles and a lack of direct dialogue for the galectin-3 inhibitor. The change extends the timeline for finalizing the design of a pivotal registration-enabling study, eroding investor confidence and triggering a rapid sell-off in the market.
The core of the issue lies in the FDA's decision to convert the company's "Type C meeting request" into a written response. While Galectin stated there was "alignment with the agency on the proposed patient population," it also conceded that "key aspects of the trial design remain unresolved."
This development forces the company to "pursue a follow-up Type C meeting" to finalize the protocol for its next clinical trial. The uncertainty and delay associated with this regulatory interaction were the primary drivers of the sharp contraction in shareholder value.
The investigation by The Portnoy Law Firm, which has a history of recovering over $5.5 billion for investors, will focus on whether the company made any misleading statements regarding its regulatory engagement and the timeline for its clinical program.
The 28.9% decline in a single day represents a significant loss of market capitalization and brings the stock to its lowest point since the announcement. For Galectin, the immediate challenge is to resolve the outstanding trial design issues with the FDA to provide a clear path forward for belapectin. Investors will be closely watching for the outcome of the follow-up Type C meeting, which now stands as the next major catalyst for the company.
This article is for informational purposes only and does not constitute investment advice.
