{"schema_version":"secwatch.filing_event.v1","accession":"0001664710-25-000073","form_type":"8-K","ticker":"KROS","cik":"0001664710","company_name":"Keros Therapeutics, Inc.","filed_at":"2025-08-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.591767+00:00","generated_at":"2026-05-17T11:10:01.038902+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Keros receives FDA Orphan Drug designation for KER-065 in Duchenne muscular dystrophy","bullets":["FDA granted Orphan Drug designation for KER-065, a TGF-ß family protein-targeting therapy for DMD.","Designation provides potential 7-year market exclusivity, tax credits, and fee waivers if approved.","KER-065 is advancing toward a Phase 2 clinical trial in patients with DMD, as stated by CEO.","DMD affects fewer than 200,000 people in the U.S., qualifying for Orphan Drug status.","Keros (KROS) is a clinical-stage biopharma focused on TGF-ß signaling disorders."],"urls":{"canonical":"https://secwatch.observer/filing/0001664710-25-000073","json":"https://secwatch.observer/filing/0001664710-25-000073.json","markdown":"https://secwatch.observer/filing/0001664710-25-000073.md","text":"https://secwatch.observer/filing/0001664710-25-000073.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1664710/000166471025000073/0001664710-25-000073-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1664710/000166471025000073/kros-20250820.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:10:01.038902+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"}