{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-185580","form_type":"8-K","ticker":"AURA","cik":"0001501796","company_name":"Aura Biosciences, Inc.","filed_at":"2022-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:04:00.944036+00:00","generated_at":"2026-06-24T21:59:18.106752+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Aura Biosciences receives FDA Fast Track for belzupacap sarotalocan in NMIBC; Phase 1 trial H2 2022","bullets":["FDA granted Fast Track designation for belzupacap sarotalocan (AU-011) for treatment of Non-Muscle Invasive Bladder Cancer.","NMIBC has no approved targeted therapies; high recurrence and progression often leading to cystectomy.","Aura plans Phase 1 trial in NMIBC starting H2 2022, with initial data expected in 2023.","AU-011 previously received Fast Track and Orphan Drug designations for choroidal melanoma, currently in Phase 2."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-185580","json":"https://secwatch.observer/filing/0001193125-22-185580.json","markdown":"https://secwatch.observer/filing/0001193125-22-185580.md","text":"https://secwatch.observer/filing/0001193125-22-185580.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1501796/000119312522185580/0001193125-22-185580-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1501796/000119312522185580/d371151d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T21:59:18.106752+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"}