MBX Biosciences
Clinical Validation of Precision Peptides for Endocrine and Metabolic Care
Key Highlights
- Competitive Phase 2 data in hypoparathyroidism (HP): Once-weekly canvuparatide hit the primary endpoint in the Phase 2 Avail™ study (63% responders at 12 weeks vs. 31% placebo) with 79% responders at 6 months in the open-label extension, supporting best-in-class potential and Phase 3 planning for 2026. End-of-Phase-2 FDA and EMA meetings are slated for Q1 2026.
- Platform for precision: Built on peptide pioneer Richard DiMarchi, Ph.D.’s science, MBX’s Precision Endocrine Peptide™ (PEP™) platform is engineered to extend peptide half-life and deliver sustained, consistent exposure—aiming to reduce dosing burden and variability while improving outcomes—now clinically validated by canvuparatide’s Phase 2 success.
- Recent $200M upsized offering extends cash runway into 2029 to fund upcoming milestones across obesity and endocrine pipeline:
- HP: present once-weekly canvuparatide Phase 2 data and 1-year OLE in Q2 2026; initiate Phase 3 in Q3 2026.
- PBH: imapextide (MBX-1416) has begun a Phase 2a STEADI™ trial with results expected in Q2 2026.
- Obesity: MBX-4291 has dosed its first participant in Phase 1; 12-week MAD readout expected in Q4 2026.