{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-065636","form_type":"8-K","ticker":"HRTX","cik":"0000818033","company_name":"HERON THERAPEUTICS, INC. /DE/","filed_at":"2024-05-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:22.067504+00:00","generated_at":"2026-06-01T07:50:37.792507+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Heron submits PAS to FDA for ZYNRELEF Vial Access Needle to simplify preparation","bullets":["PAS seeks FDA approval to replace current vented vial spike with new Vial Access Needle (VAN).","VAN reduces product withdrawal time from up to 3 minutes to 20-45 seconds, simplifying aseptic preparation.","Heron expects FDA review action date within 4-6 months; decision pending.","ZYNRELEF is already approved for postoperative pain; VAN addresses healthcare provider feedback."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-065636","json":"https://secwatch.observer/filing/0000950170-24-065636.json","markdown":"https://secwatch.observer/filing/0000950170-24-065636.md","text":"https://secwatch.observer/filing/0000950170-24-065636.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/818033/000095017024065636/0000950170-24-065636-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/818033/000095017024065636/hrtx-20240529.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T07:50:37.792507+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"}