{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-407823","form_type":"8-K","ticker":"TECX","cik":"0001681087","company_name":"Tectonic Therapeutic, Inc.","filed_at":"2026-09-29T21:19:22+00:00","discovered_at":"2026-09-29T21:20:00.381757+00:00","generated_at":"2026-10-12T13:53:50.492936+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Tectonic reports favorable TX2100 Phase 1a safety results and FDA Fast Track for HHT","bullets":["TX2100 Phase 1a single ascending doses were generally safe and well-tolerated across all six planned cohorts; no deaths, SAEs, or severe TEAEs at any dose.","FDA granted TX2100 Fast Track designation for hereditary hemorrhagic telangiectasia (HHT) and cleared the IND for a U.S. Phase 1b trial in HHT patients.","Tectonic plans an open-label Phase 1b trial in hematologic-support dependent HHT by year-end 2026 and a placebo-controlled Phase 2 in moderate-to-severe HHT in early 2027.","The Phase 1a trial enrolled 48 healthy adults ages 18-55 across six cohorts of eight, randomized 3:1 to TX2100 or placebo; Part B multiple-dose enrollment is complete.","PK results showed target-mediated drug disposition at low concentrations, supporting once weekly or every other week subcutaneous dosing; detailed data to be presented Oct. 12-16, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-407823","json":"https://secwatch.observer/filing/0001193125-26-407823.json","markdown":"https://secwatch.observer/filing/0001193125-26-407823.md","text":"https://secwatch.observer/filing/0001193125-26-407823.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1681087/000119312526407823/0001193125-26-407823-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1681087/000119312526407823/d20857d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:53:50.492936+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"}