FDA backs Galectin (NASDAQ: GALT) belapectin Phase 3 plan in MASH
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Galectin Therapeutics Inc. announced positive feedback from an in person FDA Type C meeting that supports advancing its lead drug belapectin into a Phase 3 trial for patients with MASH cirrhosis and portal hypertension. The company and FDA reached alignment on the overall study design, composite primary endpoint, and regulatory framework.
The Phase 3 trial is planned as a randomized, double-blind, placebo-controlled study using a single 2 mg dose of belapectin, focusing on preventing disease progression, including the development of large esophageal varices. FDA accepted Galectin’s blinded central endoscopy review methodology and confirmed that the proposed endpoints and structure are appropriate for a traditional full approval pathway.
Galectin plans to submit the final Phase 3 protocol in the third quarter of 2026 and is pursuing potential strategic and financial partners to support the program. Belapectin holds Fast Track designation and targets a high-risk patient group with substantial unmet medical need.
Positive
- Regulatory clarity on belapectin Phase 3: FDA provided positive Type C meeting feedback, agreeing on the Phase 3 study design, composite clinical primary endpoint, and use of a blinded central endoscopy review, and confirmed these elements are appropriate for a traditional full approval pathway in MASH cirrhosis with portal hypertension.
Negative
- None.
Insights
FDA alignment on a single pivotal Phase 3 trial meaningfully clarifies belapectin’s approval path.
Galectin Therapeutics received positive Type C meeting feedback from the FDA on its belapectin program in MASH cirrhosis with portal hypertension. Alignment covers a randomized, double-blind, placebo-controlled Phase 3 design, a composite clinical primary endpoint, and acceptance of a blinded central endoscopy review process.
The FDA confirmed that these composite outcomes and trial framework are suitable for a traditional approval pathway, rather than accelerated approval based on biopsy histology. Galectin intends to test a single 2 mg dose, leveraging efficacy observed in prior studies and experience from the NAVIGATE trial’s operational model.
Management plans to submit the Phase 3 protocol in the third quarter of 2026 and is actively exploring strategic and financial partnerships. Actual impact will depend on successful execution of the trial, robustness of outcomes on the composite liver endpoint, and Galectin’s ability to secure sufficient funding or partners to complete the program.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Type C meeting outcome: Positive FDA feedback
Phase 3 dose: 2 mg belapectin
Regulatory pathway: Traditional full approval
+3 more
6 metrics
Type C meeting outcome
Positive FDA feedback
Belapectin in MASH cirrhosis with portal hypertension
Phase 3 dose
2 mg belapectin
Single dose planned in randomized, double-blind, placebo-controlled trial
Regulatory pathway
Traditional full approval
For MASH cirrhosis population using composite clinical outcomes
Protocol submission target
Q3 2026
Final Phase 3 protocol for belapectin
FDA designation
Fast Track
Belapectin for multiple inflammatory, fibrotic, and malignant diseases
Primary endpoint feature
Development of large esophageal varices
Component of composite liver outcome in Phase 3
Key Terms
Type C meeting, MASH cirrhosis, portal hypertension, composite liver outcome, +2 more
6 terms
Type C meeting regulatory
"announcing results from its recent Type C meeting with the U.S. Food and Drug Administration"
MASH cirrhosis medical
"for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension"
portal hypertension medical
"patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension"
An increase in blood pressure in the portal venous system — the veins that carry blood from the intestines to the liver — usually caused by scarring or blockage in the liver that acts like a traffic jam in a pipe. It matters to investors because it drives demand for treatments, diagnostics and procedures, influences clinical trial outcomes and regulatory decisions, and can materially affect healthcare costs and a company’s commercial prospects in liver-related therapies.
composite liver outcome clinical
"Alignment was reached on a composite liver outcome as the primary endpoint"
blinded central review clinical
"FDA accepted the Company's proposed blinded central review process for endoscopic assessment of esophageal varices"
Fast Track designation regulatory
"for which belapectin has Fast Track designation by the U.S. Food and Drug Administration"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): June 23, 2026
(Exact name of registrant as specified in its
charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive office) (zip code)
Registrant’s telephone number, including area code: (678 ) 620-3186
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of
the Act:
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| Item 7.01 |
Regulation FD Disclosure.
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On June 23, 2026, Galectin Therapeutics Inc. (the “Company”) issued a press release
announcing results from its recent Type C meeting with the U.S. Food and Drug Administration (FDA), furnished hereto as Exhibit 99.1. and
incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information furnished under this Item 7.01 of this Current Report on Form 8-K and the
exhibit furnished hereto are deemed to be “furnished” and shall not be deemed “filed” for the purpose of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall such information and exhibit be deemed
incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
This Current Report on Form 8-K and Exhibit 99.1 hereto contain forward-looking statements within the meaning of the federal securities laws. These
forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibits 99.1 and in the other reports of the Company filed
with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
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Financial Statements and Exhibits.
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Exhibits.
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Exhibit No.
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Exhibit Description
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99.1
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Press release dated June 23, 2026
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Galectin Therapeutics Inc. has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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Galectin Therapeutics Inc.
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Date: June 23, 2026
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By:
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/s/ Jack W. Callicutt
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Jack W. Callicutt
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Chief Financial Officer
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Exhibit 99.1
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Galectin Therapeutics Announces Positive Type C Meeting with the FDA for Belapectin in Patients with MASH Cirrhosis and Portal Hypertension
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Galectin has reached agreement with the FDA on the primary endpoint and regulatory path forward for the potential full approval of belapectin
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Company intends to file the Phase 3 protocol in Q3 2026 and is actively exploring strategic and financial partnership opportunities to support the continued development and
commercialization of belapectin
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NORCROSS, Ga., June 23, 2026 – Galectin
Therapeutics Inc. (NASDAQ: GALT), a biotechnology company focused on developing therapies for patients with advanced liver disease, today announced positive feedback from its recent in person Type C meeting with the U.S. Food and Drug
Administration (FDA), supporting the advancement of belapectin for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.
Joel Lewis, Chief Executive Officer of Galectin Therapeutics, said "We are pleased to have reached agreement with FDA on the key elements of our planned Phase 3
program for belapectin. Alignment on the study design, primary endpoint, and regulatory framework provides important clarity, as we advance the program with renewed confidence. We are initiating preparations for the Phase 3 trial and in parallel are
evaluating development pathways alongside potential strategic partnership opportunities. We remain committed to patients with MASH cirrhosis and portal hypertension facing the highest risk of life-threatening decompensation events, who currently are
excluded from enrolling in other ongoing drug development efforts. Additionally, FDA acknowledged the substantial unmet medical need in this patient population during our meeting, which strengthened our dedication to continuing the development of
belapectin and our Phase 3 trial. We look forward to submitting the final Phase 3 protocol in the third quarter of 2026."
The Phase 3 trial will assess the safety and efficacy of belapectin for the prevention of disease progression in a randomized, double-blind, placebo-controlled
design in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. Alignment was reached on the following:
Primary Endpoint: Alignment was reached
on a composite liver outcome as the primary endpoint, including prevention of development of large esophageal varices (>5 mm), a clinically meaningful manifestation of worsening portal hypertension and disease progression in patients with
compensated MASH cirrhosis. Importantly, the Company plans to incorporate the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned Phase 3 study.
Central Endoscopy Review Methodology: FDA
accepted the Company's proposed blinded central review process for endoscopic assessment of esophageal varices. This methodology builds upon the approach successfully implemented in the global Phase 2b/3 NAVIGATE trial and is designed to ensure
standardized, objective, and consistent assessment of endoscopic outcomes across study sites.
Galectin recently published details of the central review methodology and operational framework developed for NAVIGATE, highlighting the
rigor and reproducibility of the process in a large multinational clinical trial.
Planned registration trial to evaluate single dose: Based on the robust efficacy observed with the 2 mg dose across prior clinical studies, the Company plans to evaluate a single 2 mg dose of belapectin in its planned Phase 3 trial. The Company believes that the planned
Phase 3 study, together with the totality of existing clinical data, has the potential to support a full approval application for belapectin in patients with MASH cirrhosis and portal hypertension.
Given the similarity of the intended study population to the NAVIGATE trial, including patients with MASH cirrhosis and portal hypertension, and the evaluation of
a single belapectin dose, the Company currently expects the planned Phase 3 trial to be of a size generally comparable to the NAVIGATE trial.
Regulatory Pathway: Consistent with FDA
guidance, the Company understands that approval in the MASH cirrhosis population will require a traditional pathway, unlike earlier-stage MASH populations where accelerated approval based on histologic endpoints may be available. The FDA confirmed
that the proposed composite outcome endpoints, including the development of large varices, and study framework are appropriate for a full approval pathway. Based on FDA's recent communication regarding use of a single, adequate and well-controlled
confirmatory trial for marketing approval, the Company believes the planned phase 3 trial provides a clear regulatory path toward a broad indication focused on preventing progression of MASH cirrhosis.
Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics, commented "FDA's acceptance of our centralized endoscopy review process underscores the
scientific rigor and operational robustness of the methodology that Galectin pioneered, and successfully implemented in the NAVIGATE trial. Standardized, blinded assessment of esophageal varices is critical to ensuring reliable and reproducible
endpoint evaluation in global studies. Importantly, the Agency's feedback supports the advancement of belapectin towards full approval, which we believe offers the opportunity to pursue a broad indication focused on preventing disease progression in
patients with MASH cirrhosis."
Galectin is advancing Phase 3 planning and is actively pursuing potential strategic and financial partners. Phase 3 protocol submission is anticipated in the
third quarter of 2026.
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 belapectin 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 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 Contact:
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) announce regarding its FDA Type C meeting?
Galectin Therapeutics reported positive feedback from an in person FDA Type C meeting on belapectin. The agency aligned with the company on the Phase 3 trial design, composite primary endpoint, and regulatory framework for patients with MASH cirrhosis and portal hypertension.
What is the planned Phase 3 trial design for belapectin at Galectin Therapeutics (GALT)?
The planned Phase 3 study is a randomized, double-blind, placebo-controlled trial evaluating a single 2 mg dose of belapectin. It will assess safety and efficacy in preventing disease progression in patients with MASH cirrhosis and portal hypertension using a composite liver outcome endpoint.
How will esophageal varices be assessed in Galectin Therapeutics’ belapectin Phase 3 trial?
FDA accepted Galectin’s proposed blinded central endoscopy review for esophageal varices assessment. This methodology, refined in the NAVIGATE trial, aims to provide standardized, objective, and consistent evaluation of variceal outcomes across global study sites within the Phase 3 program.
What regulatory pathway did the FDA indicate for belapectin in MASH cirrhosis?
For MASH cirrhosis, the FDA indicated a traditional approval pathway rather than accelerated approval. The agency confirmed that Galectin’s proposed composite clinical outcome endpoints and overall study framework are appropriate for a full approval application targeting prevention of disease progression.
When does Galectin Therapeutics expect to submit the belapectin Phase 3 protocol?
Galectin Therapeutics anticipates submitting the final Phase 3 protocol for belapectin in the third quarter of 2026. The company is simultaneously advancing operational planning for the trial and pursuing potential strategic and financial partners to support program execution.
What patient population is belapectin targeting in Galectin Therapeutics’ Phase 3 program?
Belapectin targets patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension who face high risk of life-threatening decompensation. The company notes these patients are often excluded from other drug development efforts, highlighting a substantial unmet medical need in this advanced liver disease population.