{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-172238","form_type":"8-K","ticker":"SLNO","cik":"0001484565","company_name":"SOLENO THERAPEUTICS INC","filed_at":"2024-06-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.612297+00:00","generated_at":"2026-06-01T00:32:28.390507+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Soleno submits NDA to FDA for DCCR to treat Prader-Willi Syndrome","bullets":["NDA submitted for DCCR (diazoxide choline) extended-release tablets for PWS in patients aged 4+ with hyperphagia.","DCCR holds Breakthrough Therapy and Fast Track designations in the U.S.; Orphan Drug designation in U.S. and EU.","FDA has 60 days to determine if NDA will be accepted; Soleno requested Priority Review (6-month target review).","CEO Anish Bhatnagar called the submission a significant milestone for Soleno and the PWS community."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-172238","json":"https://secwatch.observer/filing/0001193125-24-172238.json","markdown":"https://secwatch.observer/filing/0001193125-24-172238.md","text":"https://secwatch.observer/filing/0001193125-24-172238.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484565/000119312524172238/0001193125-24-172238-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484565/000119312524172238/d832323d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T00:32:28.390507+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"}