MBX Biosciences, Inc. MBX
MBX Biosciences, Inc. (Nasdaq: MBX) is an endocrine/women's health drug developer. Its lead program, canvuparatide (MBX 2109), is in Phase 2 for Chronic hypoparathyroidism. Its next catalyst on record is MBX 4291: Results from first cohort of 12-week MAD portion of Phase 1 (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: MBX 4291 — Results from first cohort of 12-week MAD portion of Phase 1 (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| canvuparatide (MBX 2109) | Chronic hypoparathyroidism (Phase 2 met primary endpoint; open-label extension ongoing; End-of-Phase 2 meeting with FDA completed Q1 2026) | protein/peptide | Phase 2 |
| imapextide (MBX 1416) | Post-bariatric hypoglycemia (Phase 2a STEADI proof of concept May 2026; no further investment in Phase 2b) | protein/peptide | Phase 2 |
| MBX 4291 | Obesity (once-monthly GLP-1/GIP co-agonist prodrug; Phase 1 SAD/MAD) | protein/peptide | Phase 1 |
| MBX 5765 | Obesity (GLP-1/GIP/GCG/DACRA; IND-enabling) | protein/peptide | Pre-clinical |
| MBX 6180 | Obesity (GLP-1/GIP/GCG; IND-enabling) | protein/peptide | Pre-clinical |
Recent results and decisions
- Aug 27, 2026started First patient dosed in the pivotal Phase 3 oPTimize trial (~160 adults, 3:1 randomized, 26-week double-blind, composite responder primary endpoint).
today announced that the first patient has been dosed in its pivotal Phase 3 oPTimize clinical trial evaluating once-weekly canvuparatide for the treatment of chronic hypoparathyroidism (HP).
Filing - Jun 12, 2026positive One-year open-label extension: 57% responder rate at one year vs 63% at 12 weeks in Avail; 90% retention; no new safety signals.
Responder rate of 57% at one year in OLE comparable to Phase 2 Avail™ rate of 63% at 12 weeks
Filing - Nov 6, 2025met Phase 2 Avail met the primary composite endpoint: 63% responders at 12 weeks; 79% responders at six months in the open-label extension.
once-weekly canvuparatide achieved the primary composite endpoint in the Phase 2 Avail™ trial in adults with hypoparathyroidism, with 63% of canvuparatide-treated patients achieving responder status at 12 weeks
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 endocrine/women's health companies
- AbCellera Biologics Inc. ABCL
- Entera Bio Ltd. ENTX
- SAB Biotherapeutics, Inc. SABS
- Vogenx, Inc. VOGX
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.