{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-210049","form_type":"8-K","ticker":"MBX","cik":"0001776111","company_name":"MBX Biosciences, Inc.","filed_at":"2025-09-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.955254+00:00","generated_at":"2026-05-17T05:59:17.967394+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"MBX Biosciences' canvuparatide meets Phase 2 primary endpoint: 63% responder rate, p=0.042, 79% at 6 months OLE","bullets":["Primary composite endpoint met: 63% (30/48) of canvuparatide patients vs 31% (5/16) placebo at Week 12 (p=0.042).","Open-label extension: 79% (44/56) achieved responder status at 6 months, including placebo crossovers.","Safety: well-tolerated, no treatment-related SAEs or discontinuations; injection site reactions 19% vs 13% placebo.","Company plans to initiate Phase 3 trial of once-weekly canvuparatide in 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-210049","json":"https://secwatch.observer/filing/0001193125-25-210049.json","markdown":"https://secwatch.observer/filing/0001193125-25-210049.md","text":"https://secwatch.observer/filing/0001193125-25-210049.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1776111/000119312525210049/0001193125-25-210049-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1776111/000119312525210049/mbx-20250922.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:59:17.967394+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}