Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027
Rhea-AI Summary
Galectin Therapeutics (NASDAQ:GALT) reported an FDA written response to its Type C meeting request on belapectin, noting alignment on the proposed registration-trial patient population and prior agreement to use a centralized, blinded endoscopy review for variceal assessment.
The company will request a follow-up Type C meeting to finalize unresolved trial-design components and present recently generated biomarker data from the AASLD meeting. Separately, chairman Richard E. Uihlein provided a new $10 million unsecured, convertible line of credit and extended existing convertible facilities to June 30, 2027, supporting cash sufficiency through at least March 2027.
Positive
- $10 million new unsecured convertible line of credit
- Convertible credit maturities extended to June 30, 2027
- Company reports alignment with FDA on patient population
- Agreement to use centralized, blinded endoscopy review
Negative
- Remaining trial-design components require a follow-up Type C meeting
- Cash runway supported only through at least March 2027
News Market Reaction
On the day this news was published, GALT declined 28.90%, reflecting a significant negative market reaction. Argus tracked a trough of -44.6% from its starting point during tracking. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $161M from the company's valuation, bringing the market cap to $397M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed, mostly modest moves (e.g., AUTL -1.26%, BNTC +4.79%, DMAC -1.89%, LRMR -2%, VIGL flat), suggesting stock-specific factors for GALT.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 14 | Earnings & update | Neutral | -0.4% | Q3 2025 results and NAVIGATE biomarker update submitted to FDA. |
| Nov 10 | Clinical data | Positive | +0.0% | Phase 2b NAVIGATE results for belapectin in 355 MASH cirrhosis patients. |
| Oct 20 | Investor conference | Neutral | +2.0% | Planned H.C. Wainwright MASH investor conference presentation and meetings. |
| Oct 07 | Conference preview | Positive | +7.4% | Announcement of AASLD 2025 oral and poster presentations on NAVIGATE. |
| Sep 02 | Investor conference | Neutral | +3.3% | Participation in H.C. Wainwright Global Investment Conference in New York. |
Recent news, especially conference and data presentations, has generally aligned with modest positive or stable price reactions, indicating the stock often tracks the tone of its own catalysts.
Over the last few months, Galectin has focused on belapectin’s NAVIGATE trial data and investor visibility. A Q3 2025 update on financials and NAVIGATE biomarkers on Nov 14 was followed by detailed Phase 2b results at AASLD on Nov 10. Multiple conference appearances in September and October 2025 highlighted MASH cirrhosis and portal hypertension data. Price reactions around these events were modest but mostly aligned with neutral-to-positive news flow, framing today’s FDA feedback and new financing as a continuation of this development path.
Market Pulse Summary
The stock dropped -28.9% in the session following this news. A negative reaction despite regulatory progress could fit concerns around financing structure and prior insider selling activity. While the update described FDA alignment on the proposed registration-trial population and outlined plans for a pivotal Phase 3, some investors might have focused on execution risk. The additional $10 million convertible credit line and maturities extended to June 30, 2027 support operations through at least March 2027, but do not eliminate development or funding uncertainties.
Key Terms
endoscopy medical
esophageal variceal medical
biomarker medical
surrogate markers medical
portal hypertension medical
phase 3 clinical
line of credit financial
AI-generated analysis. Not financial advice.
NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today 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.
Pursuant to the written response from FDA, Galectin Therapeutics will pursue a follow-up Type C meeting to finalize remaining components of the next clinical trial design that were not fully resolved in the written response. This follow-up meeting will also provide an opportunity to present recently generated biomarker data, including findings highlighted at last month’s American Association for the Study of Liver Diseases (AASLD) meeting, which could not be incorporated in the original submission due to our stated objective of obtaining FDA feedback before the end of 2025.
The Company views this next FDA interaction as an important step toward ensuring full clarity as it advances belapectin towards subsequent clinical development in a pivotal Phase 3 clinical trial. Galectin Therapeutics is also encouraged that the planned meeting will allow participation from prominent key opinion leaders, whose insights could not be integrated into the prior written-only exchange.
Galectin Therapeutics remains committed to advancing belapectin’s development for patients with advanced fibrotic liver disease and continues to engage constructively with the FDA as it progresses the program.
Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics, stated, “We appreciate the FDA’s written feedback and are encouraged by the agency’s evolving consideration of non-invasive tools and surrogate markers into clinical development for MASH cirrhosis. We look forward to discussing our updated data set within that regulatory context and further refining the clinical development strategy for belapectin.”
Separately, the Company has entered into a new
Joel Lewis, Chief Executive Officer at Galectin Therapeutics, added, “Our focus remains on advancing belapectin for patients with MASH cirrhosis and portal hypertension. We were pleased to receive feedback prior to year-end and look forward to continued dialogue as we work to finalize the next stage of clinical development. The strength of the data generated to date reinforces our confidence in belapectin’s potential, and we look forward to advancing this program with continued momentum. Finally, I would like to express our gratitude to Mr. Uihlein for once again increasing his commitment to the Company through the newest
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’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. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on the Company’s cash resources and finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect”, “look forward”, “believe”, “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not produce positive data; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin.
FAQ
What did Galectin Therapeutics (GALT) receive from the FDA on December 19, 2025?
How does the FDA feedback affect belapectin trial design for GALT?
What financing did Galectin Therapeutics announce on December 19, 2025?
How long is GALT's revised credit maturity and cash runway after the financing?
Will Galectin Therapeutics present new data to the FDA for belapectin?
What are investor implications of GALT's December 19, 2025 update?
