MBX Biosciences successful End-of-Phase 2 FDA meeting; Phase 3 trial for canvuparatide in Q3 2026

MBX Biosciences, Inc.

Phase 3 double-blind placebo-controlled trial will enroll ~160 patients; 3:1 randomization, 4-week fixed 600 ug dose then 18-week titration, 4-week maintenance.
Primary endpoint: proportion of participants achieving normal serum calcium and independence from conventional therapy at Week 26; open-label extension after.
Canvuparatide granted Orphan Drug Designation by European Medicines Agency for chronic hypoparathyroidism.
Company on track to initiate Phase 3 trial in Q3 2026 based on FDA feedback from End-of-Phase 2 meeting.

item 7.01item 8.01item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.