{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-016776","form_type":"8-K","ticker":"AYTU","cik":"0001385818","company_name":"AYTU BIOPHARMA, INC","filed_at":"2023-10-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.823082+00:00","generated_at":"2026-06-09T08:18:01.244711+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Aytu BioPharma receives FDA approval for Cotempla XR-ODT site transfer, expects margin boost in 2024","bullets":["FDA approved Cotempla XR-ODT Prior Approval Supplement (PAS) for manufacturing transfer to contract manufacturer.","Adzenys XR-ODT received similar PAS approval in April 2023; both ADHD brands moving to contract production.","Company expects enhanced ADHD product margins starting calendar 2024 after exiting Grand Prairie facility.","Production ramp-up expected late 2023; Adzenys production already underway at contract manufacturer.","CEO cites multi-year effort: bioequivalence studies, strong contract partners, and regulatory navigation."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-016776","json":"https://secwatch.observer/filing/0001558370-23-016776.json","markdown":"https://secwatch.observer/filing/0001558370-23-016776.md","text":"https://secwatch.observer/filing/0001558370-23-016776.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1385818/000155837023016776/0001558370-23-016776-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1385818/000155837023016776/aytu-20231025x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T08:18:01.244711+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"}