{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-122237","form_type":"8-K","ticker":"SLNO","cik":"0001484565","company_name":"SOLENO THERAPEUTICS INC","filed_at":"2024-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.610852+00:00","generated_at":"2026-06-03T05:30:04.420307+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Soleno gets FDA Breakthrough Therapy Designation for DCCR in Prader-Willi Syndrome","bullets":["FDA grants Breakthrough Therapy Designation for DCCR (diazoxide choline) in adults/children ≥4 yrs with PWS and hyperphagia.","First ever Breakthrough Therapy Designation for a drug developed for PWS; based on Phase 3 program data.","NDA submission for DCCR in PWS remains on track for mid-2024.","DCCR also has Orphan Drug Designation in US and EU and Fast Track Designation in US."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-122237","json":"https://secwatch.observer/filing/0001193125-24-122237.json","markdown":"https://secwatch.observer/filing/0001193125-24-122237.md","text":"https://secwatch.observer/filing/0001193125-24-122237.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484565/000119312524122237/0001193125-24-122237-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484565/000119312524122237/d827294d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T05:30:04.420307+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"}