{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-006964","form_type":"8-K","ticker":"AYTU","cik":"0001385818","company_name":"AYTU BIOPHARMA, INC","filed_at":"2023-04-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.663020+00:00","generated_at":"2026-06-16T08:40:59.260635+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Aytu BioPharma gets FDA approval for Adzenys site transfer; 15% margin improvement expected","bullets":["FDA approved Prior Approval Supplement to transfer Adzenys XR-ODT manufacturing to contract manufacturer in 2023.","Cotempla XR-ODT bioequivalence study completed; site transfer PAS submission expected mid-2023 with approval by late 2023 or early 2024.","Upon completion of both site transfers, Aytu expects 15% margin improvement for ADHD product line.","Manufacturing of Adzenys and Cotempla at contract facility expected to begin late 2023 and early 2024 respectively."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-006964","json":"https://secwatch.observer/filing/0001558370-23-006964.json","markdown":"https://secwatch.observer/filing/0001558370-23-006964.md","text":"https://secwatch.observer/filing/0001558370-23-006964.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1385818/000155837023006964/0001558370-23-006964-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1385818/000155837023006964/aytu-20230427x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T08:40:59.260635+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"}