MBX Biosciences Soars 10.89% on FDA Drug Application

On June 18, 2025, MBX Biosciences saw a significant pre-market rise of 10.89%, driven by the company's recent announcement of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug designed for the treatment of obesity.

MBX 4291 is a novel therapeutic candidate developed using MBX Biosciences' proprietary PEP™ platform technology. This platform is designed to create precision peptide therapies with extended duration of action and improved gastrointestinal tolerability, potentially leading to better patient adherence and increased weight loss. The company aims to initiate a Phase 1 trial for MBX 4291 in the third quarter of 2025, focusing on healthy overweight volunteers.

MBX Biosciences is also advancing multiple early-stage obesity candidates using its proprietary platform. The company's pipeline includes canvuparatide (MBX 2109) in Phase 2 development for chronic hypoparathyroidism, imapextide (MBX 1416) in Phase 1 development for post-bariatric hypoglycemia, and an obesity portfolio that includes MBX 4291. The company's strategic focus on precision peptide therapies positions it well in the competitive landscape of endocrine and metabolic disorders.