Galectin Therapeutics Receives FDA Written Response on Belapectin Development Program
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 19 2025
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Galectin Therapeutics announced that the U.S. Food and Drug Administration, FDA, has provided a written response, and subsequent communications, to the Company's previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the Company's initial request for an in-person or teleconference meeting to a written response. Based on FDA's written feedback, the Company believes there is alignment with the Agency on the patient population proposed for enrollment in a registration trial. In addition, Galectin Therapeutics had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study.
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Analyst Views on GALT
Wall Street analysts forecast GALT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GALT is 11.00 USD with a low forecast of 11.00 USD and a high forecast of 11.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.930
Low
11.00
Averages
11.00
High
11.00
Current: 2.930
Low
11.00
Averages
11.00
High
11.00
About GALT
Galectin Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing therapies to improve the lives of patients with chronic liver disease and cancer. The Company’s drug candidates are based on its method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. The Company’s lead drug, belapectin, is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. The Company's additional development programs are in the treatment of combination immunotherapy for advanced head and neck cancers and other malignancies.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Galectin Therapeutics Under Investigation, Stock Plummets 28.9%
- Investigation Launched: Pomerantz LLP is investigating Galectin Therapeutics Inc. and its executives for potential securities fraud or other unlawful business practices, which could undermine investor confidence and lead to further stock volatility.
- FDA Response: On December 19, 2025, Galectin announced that the FDA provided a written response to its meeting request regarding the belapectin development program, indicating alignment on the proposed patient population for a registration trial, but unresolved key aspects of the trial design may delay clinical trial progress.
- Stock Price Drop: Following the FDA news, Galectin's stock price fell by $1.78, or 28.9%, closing at $4.38 per share, reflecting market concerns and diminished confidence in the company's future prospects.
- Legal Matters: Pomerantz LLP, a prominent securities class action law firm, has been advocating for the rights of securities fraud victims for over 85 years; unfavorable investigation outcomes could lead to significant damages against the company, further impacting its financial health.
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Galectin Therapeutics Under Investigation, Stock Plummets 28.9%
- Securities Fraud Investigation: Pomerantz LLP is investigating Galectin Therapeutics and its executives for potential securities fraud and other unlawful business practices, which could undermine investor confidence and lead to stock volatility.
- FDA Meeting Update: On December 19, 2025, Galectin announced that the FDA provided a written response to its Type C meeting request regarding the development program for belapectin, indicating alignment on the patient population but leaving key trial design aspects unresolved.
- Stock Price Plunge: Following the FDA news, Galectin's stock price fell by $1.78, or 28.9%, closing at $4.38 per share, reflecting market concerns about the company's future prospects.
- Legal Background: Pomerantz LLP, a prominent securities class action law firm with over 85 years of experience, focuses on advocating for victims of securities fraud and corporate misconduct, potentially offering legal support to affected investors.
Continue Reading