MBX · MBX Biosciences, Inc. Common Stock

Summary

MBX Biosciences announced completion of an End-of-Phase 2 meeting with the FDA and plans to initiate a Phase 3 trial for once-weekly canvuparatide for chronic hypoparathyroidism in Q3 2026. The trial will enroll approximately 160 patients in a 3:1 randomization to canvuparatide or placebo, with primary endpoint of normal serum calcium and independence from conventional therapy at week 26.

Key takeaways

• Completed End-of-Phase 2 FDA meeting on March 9, 2026
• Phase 3 trial initiation planned for Q3 2026
• Phase 3 double-blind placebo-controlled trial enrolling ~160 patients randomized 3:1
• 4-week fixed dose of 600 ug canvuparatide, 18-week titration, 4-week maintenance
• Primary endpoint at week 26: proportion achieving normal serum calcium and independence from conventional therapy
• Orphan Drug Designation granted by European Medicines Agency for chronic HP