Galectin Therapeutics Inc

Galectin Therapeutics announced that Chairman Richard E. Uihlein has converted all outstanding principal and accrued interest under five of the company's six line of credit facilities into common stock, eliminating approximately $105.8 million in total debt. The conversion, effective July 31, 2026, involved the issuance of 34,376,167 shares to Mr. Uihlein at a blended average conversion price of approximately $3.07 per share. The eliminated debt consisted of $91.0 million in principal and approximately $14.8 million in accrued interest. A sixth facility, dated December 19, 2025, providing up to $10 million in additional financing, remains undrawn and available to the company. Following the conversion, Galectin had 100,849,644 shares of common stock outstanding.

Q32 Bio led biotech gainers Monday with shares soaring over 90% after its Phase 2 SIGNAL-AA trial of Bempikibart in severe alopecia areata showed 40% of patients in the modified intent-to-treat group achieved 20% or less scalp hair loss by Week 36. The company plans a registration-directed program in the first half of 2027 and also announced a $200 million public offering. Agenus jumped over 82% after entering an $85 million private placement to fund its planned Phase 3 ROBBIN1 trial of botensilimab and balstilimab in MSS colon cancer, with first patient dosing expected in early 2027. Actuate Therapeutics gained over 23% following last month's news that its drug Elraglusib will be evaluated in the BEACON2 pediatric neuroblastoma trial. Galectin Therapeutics rose over 13% after reaching an FDA agreement on the primary endpoint for its Phase 3 study of Belapectin in MASH cirrhosis. Amwell and Shoulder Innovations each gained over 11% on no specific news, with Amwell expecting second-quarter revenue of $48 million to $52 million and Shoulder Innovations raising its full-year revenue guidance to between $65 million and $68 million.

Galectin Therapeutics shares surged 11.4% on Tuesday after the company announced it had reached alignment with the FDA on key elements of the late-stage development program for belapectin, its only clinical-stage drug candidate. The FDA feedback, following an in-person Type C meeting, provides clarity on the clinical and regulatory pathway toward potential approval for patients with metabolic dysfunction-associated steatohepatitis cirrhosis and portal hypertension. The agency agreed on the planned phase III study design, primary endpoint, central review methodology, and overall regulatory framework, and acknowledged the substantial unmet medical need in this population. Galectin now plans to submit the final phase III study protocol in the third quarter of 2026 while exploring strategic and financial partnership opportunities to support development and commercialization.

Several biotech stocks surged on Tuesday, led by Boundless Bio which agreed to an all-stock merger with privately held Serapha Bio. Boundless Bio expects to declare a cash dividend to pre-merger stockholders before the deal closes in the fourth quarter of 2026, after which the combined company will operate as Serapha Bio and trade on Nasdaq under the ticker AATD. Monopar Therapeutics rose over 19% with its New Drug Application for ALXN1840 in Wilson disease on track for mid-2026 submission to the FDA. Galectin Therapeutics gained over 11% after reaching an agreement with the FDA on key elements of its planned Phase 3 program for Belapectin in MASH cirrhosis with portal hypertension, with the final protocol expected in the third quarter of 2026. Other notable movers included Jade Biosciences, up nearly 13% amid progress in its autoimmune pipeline, and Treace Medical Concepts, up almost 12% following the first surgical use of its HyperPlate XM implant.

Galectin Therapeutics has reached agreement with the FDA on the primary endpoint and regulatory path for a planned Phase 3 trial of belapectin in patients with MASH cirrhosis and portal hypertension. The company intends to file the Phase 3 protocol in the third quarter of 2026 and is actively exploring strategic and financial partnership opportunities to support continued development and commercialization. The trial will assess a single 2 mg dose of belapectin in a randomized, double-blind, placebo-controlled design, with a composite liver outcome as the primary endpoint that includes prevention of large esophageal varices. The FDA accepted the company's proposed blinded central endoscopy review methodology, which builds on the approach used in the global Phase 2b/3 NAVIGATE trial. Galectin expects the planned Phase 3 study, together with existing clinical data, to potentially support a full approval application under a traditional regulatory pathway.