secwatch.observer — SEC 8-K summary
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Issuer:     MBX Biosciences, Inc. (MBX)
CIK:        0001776111
Form:       8-K
Filed at:   2026-06-12T11:05:58+00:00
Accession:  0001193125-26-268477
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MBX Biosciences announces sustained one-year data for once-weekly canvuparatide in hypoparathyroidism
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- 57% of evaluable patients (31/54) achieved responder status at one year, comparable to 63% at 12 weeks in Phase 2 Avail trial.
- PK profile supports once-weekly dosing with peak-to-trough ratio of ~1.3 over one week, ensuring stable exposure.
- Mean eGFR increased from baseline at Week 12 and remained improved through one year; urine calcium decreased and stayed normal.
- Canvuparatide was well tolerated; no treatment-related serious adverse events; injection site reactions in 10% of OLE patients.
- Phase 3 pivotal trial remains on track to initiate in Q3 2026; 90% of OLE patients continued treatment at one year.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1776111/000119312526268477/0001193125-26-268477-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1776111/000119312526268477/mbx-20260612.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-268477

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer