{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-21-133095","form_type":"8-K","ticker":"INCY","cik":"0000879169","company_name":"INCYTE CORP","filed_at":"2021-11-02T23:59:59+00:00","discovered_at":"2026-05-14T18:04:15.955061+00:00","generated_at":"2026-06-28T15:28:43.552425+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Incyte reports 3 product complaints for Opzelura cream; suspends affected batches","bullets":["Three product complaints received for Opzelura (ruxolitinib) cream related to texture.","FDA notified; root cause analysis underway; early testing shows no safety/efficacy issues.","Texture issue due to small amount of API not fully dissolved, causing slight gritty texture.","Distribution of affected batches suspended; no commercial supply issues at this time.","60g tubes that passed release and 90-day QC remain available; manufacturing continues."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-21-133095","json":"https://secwatch.observer/filing/0001104659-21-133095.json","markdown":"https://secwatch.observer/filing/0001104659-21-133095.md","text":"https://secwatch.observer/filing/0001104659-21-133095.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/879169/000110465921133095/0001104659-21-133095-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/879169/000110465921133095/tm2131721d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T15:28:43.552425+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"}