{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-188881","form_type":"8-K","ticker":"TECX","cik":"0001681087","company_name":"Tectonic Therapeutic, Inc.","filed_at":"2024-07-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.089419+00:00","generated_at":"2026-05-31T15:20:08.045107+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Tectonic Therapeutic receives FDA IND clearance for lead program TX45 in PH-HFpEF","bullets":["FDA cleared IND for TX45 (Fc-relaxin fusion) for Group 2 PH due to HFpEF, a condition with no approved therapy affecting >600K US patients.","Phase 1a healthy volunteer topline results due September 2024; Phase 1b patient hemodynamic topline results expected mid-2025.","Phase 2 trial to start Q3 2024: 24-week SC dosing, up to 180 subjects; primary endpoint PVR change. Topline results anticipated in 2026.","TX45 engineered for optimized pharmacology targeting vasodilation, diastolic dysfunction, and remodeling to improve exercise capacity."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-188881","json":"https://secwatch.observer/filing/0001193125-24-188881.json","markdown":"https://secwatch.observer/filing/0001193125-24-188881.md","text":"https://secwatch.observer/filing/0001193125-24-188881.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1681087/000119312524188881/0001193125-24-188881-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1681087/000119312524188881/d783068d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T15:20:08.045107+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"}