Core Viewpoint - Galectin Therapeutics Inc. is under investigation for potential violations of federal securities laws following a significant drop in its stock price after an FDA communication regarding its drug development program [1][3]. Group 1: Company Developments - On December 19, 2025, Galectin Therapeutics announced that the FDA provided a written response to its Type C meeting request concerning the development of belapectin, an investigational galectin-3 inhibitor [2]. - The FDA's response converted the company's request for an in-person or teleconference meeting into a written format, indicating that while there is alignment on the proposed patient population for a registration trial, key aspects of the trial design remain unresolved [2]. Group 2: Market Reaction - Following the FDA's communication, Galectin's stock price experienced a decline of over 28% on the same day [3].

New York, New York--(Newsfile Corp. - January 14, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into Galectin Therapeutics Inc. ("Galectin Therapeutics Inc.") (NASDAQ: GALT) concerning potential violations of the federal securities laws.Galectin issued a press release on December 19, 2025, "announc[ing] 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 req ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Galectin Therapeutics Inc. and its officers or directors [1] Group 1: Company Developments - 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, an investigational galectin-3 inhibitor [3] - The FDA's response converted the initial request for an in-person or teleconference meeting to a written format, indicating that key aspects of the trial design remain unresolved despite alignment on the proposed patient population for a registration trial [3] Group 2: Market Reaction - Following the news of the FDA's response, Galectin's stock price fell by $1.78 per share, or 28.9%, closing at $4.38 per share on December 19, 2025 [4]

Core Viewpoint - The Schall Law Firm is investigating Galectin Therapeutics Inc. for potential violations of securities laws related to misleading statements and failure to disclose important information to investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Galectin issued false or misleading statements regarding its development program for belapectin, an investigational galectin-3 inhibitor [2]. - On December 19, 2025, Galectin announced that the FDA provided a written response to its Type C meeting request, which was initially sought as an in-person or teleconference meeting [2]. - Following the announcement, Galectin's shares experienced a significant decline of 28.9% on the same day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

NEW YORK, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Galectin Therapeutics Inc. (“Galectin” or the “Company”) (NASDAQ: GALT).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Galectin and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] Dec ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Galectin Therapeutics Inc. and its officers or directors [1] Group 1: Company Developments - Galectin Therapeutics announced that the FDA provided a written response to its Type C meeting request regarding the development program for belapectin, an investigational galectin-3 inhibitor [2] - The FDA's response converted the initial request for an in-person or teleconference meeting to a written format, indicating ongoing communication between the company and the agency [2] - Galectin plans to pursue a follow-up Type C meeting with the FDA to finalize the remaining components of its next clinical trial design, although key aspects of the trial design remain unresolved [2] Group 2: Market Reaction - Following the announcement regarding the FDA's response, Galectin's stock price fell by $1.78 per share, representing a 28.9% decrease, closing at $4.38 per share on December 19, 2025 [3]

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 C ...

Financial Data and Key Metrics Changes - The company is currently trading at close to multi-year highs, indicating a positive market sentiment and performance [18] - The Navigate trial's top-line results were presented, showing a lower rate of new varices with the two-milligram dose of belapectin compared to placebo after 18 months, although not statistically significant in the overall population [24] Business Line Data and Key Metrics Changes - The focus has been on analyzing biomarker data from the Navigate trial to support the efficacy of belapectin in treating MASH cirrhosis and portal hypertension [21][25] - Significant findings include a lower rate of new varices in patients treated with belapectin compared to placebo, particularly in those with advanced fibrosis [26] Market Data and Key Metrics Changes - The company has engaged with key opinion leaders (KOLs) and presented findings at major hepatology conferences, enhancing its visibility and credibility in the market [22] - The Navigate trial enrolled one of the most advanced compensated MASH cirrhosis populations studied to date, which may influence market perception and potential partnerships [29] Company Strategy and Development Direction - The company aims to maximize the value of its program and is exploring strategic opportunities to advance belapectin, which has the potential to change the treatment landscape for patients with no FDA-approved therapies [23] - Continued engagement with clinicians and KOLs is planned to further validate and communicate the clinical findings of belapectin [22] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the company's current position and the extensive data available to support its programs [18] - The company anticipates feedback from the FDA regarding its submitted package and is optimistic about the future of its treatment options [23] Other Important Information - The company has maintained a clean safety profile for belapectin, with no drug-related serious adverse events reported during the Navigate trial [29] - The results from the Navigate trial are expected to lead to further discussions with potential partners committed to advancing belapectin [29] Q&A Session Summary Question: What are the key findings from the Navigate trial? - The two-milligram dose of belapectin showed a lower rate of new varices compared to placebo, particularly in the completer population [24] - Biomarker analyses indicated that belapectin may stabilize MASH cirrhosis over time and reduce key inflammatory pathways [26][27] Question: What are the next steps for the company? - The company is finalizing remaining analyses and looks forward to working with the FDA to determine next steps for the belapectin program [29] - Active discussions with potential partners are ongoing to advance the treatment for patients with no approved options [29]

Core Viewpoint - Galectin Therapeutics reported positive clinical data for belapectin, indicating its potential to slow disease progression in patients with compensated MASH cirrhosis, and submitted the NAVIGATE data package to the FDA for feedback on next steps [2][4]. Clinical Data Summary - The NAVIGATE trial presented at AASLD showed consistent improvements in key biomarkers, including FibroScan, ELF, and PRO-C3, supporting belapectin's antifibrotic activity [2][4]. - Belapectin demonstrated a significant reduction in clinically significant portal hypertension (CSPH) risk categories, with a decrease from 33.3% to 25.9% in the 2 mg/kg group, compared to a smaller decrease from 34.2% to 32.9% in the placebo group [8]. - The treatment also improved the no/low-risk category for CSPH, increasing from 42.0% to 56.8% in the belapectin group versus an increase from 44.7% to 51.3% in the placebo group [8]. Financial Highlights - As of September 30, 2025, the company reported cash and cash equivalents of $11.5 million, with total assets of $12.9 million [14]. - Research and development expenses for Q3 2025 were $2.6 million, a decrease from $7.6 million in Q3 2024, primarily due to the timing of expenditures related to the NAVIGATE trial [6][12]. - The net loss applicable to common stockholders for Q3 2025 was $8.2 million, or ($0.13) per share, compared to a net loss of $11.2 million, or ($0.18) per share in Q3 2024 [12][13].

Core Insights - Galectin Therapeutics Inc. presented findings from the NAVIGATE study, focusing on the efficacy of belapectin, a galectin-3 inhibitor, in treating patients with compensated MASH cirrhosis and portal hypertension [1][2] Study Overview - The NAVIGATE trial was a Phase 2b randomized, double-blind, placebo-controlled study involving 355 patients, assessing the effects of belapectin administered at doses of 2 mg/kg and 4 mg/kg every other week for 18 months [2] - The study aimed to evaluate the impact of belapectin on the incidence of new esophageal varices and liver fibrosis progression [2][4] Efficacy Results - Belapectin 2 mg/kg showed a significantly lower incidence of new varices compared to placebo, particularly in patients with an ELF score >11.3 (22.7% vs 42.9%) [3][4] - At 18 months, patients receiving 2 mg/kg belapectin achieved a mean reduction of 6.4 ng/mL in Pro-C3 levels, indicating over 50% improvement from baseline [3][5] - The treatment also demonstrated a lower incidence of clinically meaningful worsening in liver stiffness compared to placebo, suggesting a slowing of fibrosis progression [4] Biomarker Analysis - Analysis of YKL-40 showed a ≥20% reduction in a higher proportion of patients treated with belapectin 2 mg/kg compared to placebo (33.8% vs 23.1%), supporting its antifibrotic activity [6][7] - PRO-C4 analysis indicated a ≥20% increase from baseline occurred more frequently in placebo-treated patients (13% vs 3%), reinforcing belapectin's potential to modify disease progression [7] Long-term Outcomes - The reduction in new varices observed at 18 months was sustained through 36 months, with cumulative incidences of new varices at 36 months being 23.4% for placebo, 12.4% for 2 mg/kg, and 16.7% for 4 mg/kg cohorts [8] - The safety profile of belapectin remained favorable, with adverse events comparable across treatment groups and no drug-related serious adverse events reported [9] Expert Commentary - Experts highlighted the long-term NAVIGATE data as significant, noting the sustained improvements in liver stiffness and biomarkers, which suggest a consistent antifibrotic effect [10] - The company expressed optimism about advancing regulatory discussions and exploring partnerships to further develop belapectin, emphasizing its potential to address a significant unmet medical need in MASH cirrhosis [10][11]