{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-144511","form_type":"8-K","ticker":"SLNO","cik":"0001484565","company_name":"SOLENO THERAPEUTICS INC","filed_at":"2026-04-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.348175+00:00","generated_at":"2026-05-15T06:59:48.535599+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Soleno withdraws EU marketing application for VIOKAT (PWS hyperphagia)","bullets":["Voluntarily withdrew MAA for VIOKAT (diazoxide choline) from EMA for Prader-Willi syndrome hyperphagia.","Decision based on business and strategic considerations; company may re-engage with regulators later.","VIOKAT is marketed in the US as VYKAT XR for adults and children aged 4+ with PWS."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-144511","json":"https://secwatch.observer/filing/0001193125-26-144511.json","markdown":"https://secwatch.observer/filing/0001193125-26-144511.md","text":"https://secwatch.observer/filing/0001193125-26-144511.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484565/000119312526144511/0001193125-26-144511-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484565/000119312526144511/d141594d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:59:48.535599+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"}