MBX News & Events

MBX Biosciences files automatic mixed securities shelf

"2025 was a year of continued growth and execution for MBX, highlighted by the clinical validation of our Precision Endocrine Peptide platform," said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. "Following a successful End-of-Phase 2 meeting with the FDA, we now have a clear path to initiate our Phase 3 trial of once-weekly canvuparatide. We are also advancing a growing obesity pipeline, built on our clinically validated PEPTM platform and designed for once-monthly dosing and improved tolerability. We look forward to a data-rich year ahead and to continuing our pursuit of bringing differentiated and best-in-class medicines to patients."

MBX Biosciences announced the appointment of Karen Basbaum, MBA, as Chief Business Officer, CBO. Prior to joining MBX Biosciences, Basbaum served as Senior Vice President of Business Development at Poseida Therapeutics

MBX Biosciences announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the overall Phase 3 trial design for once-weekly canvuparatide for the treatment of chronic hypoparathyroidism. Based on feedback from the FDA, MBX plans to advance once-weekly canvuparatide into a Phase 3 trial in the third quarter of 2026. Phase 3 trial design elements have now been selected, including the number of patients, primary endpoint and key secondary endpoints, as well as dose selection, titration schedule and duration of the study. The Phase 3 double-blind placebo-controlled trial will enroll approximately 160 patients, randomized in a 3:1 ratio to receive canvuparatide or placebo. Following randomization, there will be a 4-week fixed dose period of 600 mg canvuparatide, followed by an 18-week dose-titration period, and a 4-week maintenance period. The primary efficacy analysis will be assessed at Week 26, followed by a transition to an open label extension to assess both long-term safety and durability of effect. The Company also announced today that once-weekly canvuparatide has been granted orphan drug designation by the European Medicines Agency for the treatment of chronic hypoparathyroidism, supporting its continued clinical development in Europe.