{"schema_version":"secwatch.filing_event.v1","accession":"0001714899-26-000030","form_type":"8-K","ticker":"DNLI","cik":"0001714899","company_name":"Denali Therapeutics Inc.","filed_at":"2026-03-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.985366+00:00","generated_at":"2026-05-15T09:02:11.965398+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Denali Therapeutics receives FDA approval for AVLAYAH in Hunter syndrome","bullets":["FDA grants accelerated approval for AVLAYAH (tividenofusp alfa) to treat neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients ≥5 kg.","First FDA-approved biologic designed to cross the blood-brain barrier using TransportVehicle platform.","Approval based on 91% reduction in CSF heparan sulfate biomarker at week 24; 93% of patients reached normal range.","Most common adverse reaction: infusion-related reactions; continued approval contingent on confirmatory COMPASS trial.","FDA awarded Rare Pediatric Disease Priority Review Voucher (PRV) in connection with approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001714899-26-000030","json":"https://secwatch.observer/filing/0001714899-26-000030.json","markdown":"https://secwatch.observer/filing/0001714899-26-000030.md","text":"https://secwatch.observer/filing/0001714899-26-000030.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000030/0001714899-26-000030-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1714899/000171489926000030/dnli-20260325.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T09:02:11.965398+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"}