{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-097611","form_type":"8-K","ticker":"MBX","cik":"0001776111","company_name":"MBX Biosciences, Inc.","filed_at":"2026-03-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.139497+00:00","generated_at":"2026-05-15T18:03:16.371294+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"MBX Biosciences successful End-of-Phase 2 FDA meeting; Phase 3 trial for canvuparatide in Q3 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-097611","json":"https://secwatch.observer/filing/0001193125-26-097611.json","markdown":"https://secwatch.observer/filing/0001193125-26-097611.md","text":"https://secwatch.observer/filing/0001193125-26-097611.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1776111/000119312526097611/0001193125-26-097611-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1776111/000119312526097611/mbx-20260309.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T18:03:16.371294+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"}