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Biotech Firms BOLD, MNPR, GALT Post Gains on Corporate, Regulatory News

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Regulatory

Biotech companies Bold Therapeutics, Monopar Therapeutics Inc. (MNPR), and Galectin Therapeutics Inc. (GALT) recorded significant share price increases on June 24, 2026, following distinct corporate and regulatory developments. Bold Therapeutics announced a strategic restructuring aimed at a new operational phase. Monopar Therapeutics Inc. (MNPR) confirmed its New Drug Application (NDA) filing for Validive (clonidine mucobuccal tablet) remains on track for Q4 2026. This timeline follows positive feedback from a recent Type B meeting with the U.S. Food and Drug Administration (FDA), solidifying the path for its oral mucositis treatment. Separately, Galectin Therapeutics Inc. (GALT) announced alignment with the FDA on the design of its NAVIGATE Phase 2b/3 clinical trial. The FDA agreed to use "hepatic decompensation events" as the primary endpoint for the trial, which evaluates cirrhotics with compensated NASH and high-risk esophageal varices, marking a key regulatory milestone.

EditorTan Wei Jie