{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-265687","form_type":"8-K","ticker":"SLNO","cik":"0001484565","company_name":"SOLENO THERAPEUTICS INC","filed_at":"2024-11-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.560851+00:00","generated_at":"2026-05-29T17:47:09.303368+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA extends PDUFA date for Soleno's DCCR NDA to March 27, 2025","bullets":["FDA extended review period by three months from Dec 27, 2024, to March 27, 2025.","Extension due to FDA deeming responses to recent info requests a major amendment.","FDA did not cite any safety, efficacy, or manufacturing concerns in correspondence.","NDA for DCCR to treat hyperphagia in Prader-Willi syndrome patients aged 4+.","DCCR has Breakthrough, Fast Track, and Orphan Drug designations in US and EU."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-265687","json":"https://secwatch.observer/filing/0001193125-24-265687.json","markdown":"https://secwatch.observer/filing/0001193125-24-265687.md","text":"https://secwatch.observer/filing/0001193125-24-265687.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484565/000119312524265687/0001193125-24-265687-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484565/000119312524265687/d802129d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T17:47:09.303368+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"}