{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-113564","form_type":"8-K","ticker":"RFL","cik":"0001713863","company_name":"Rafael Holdings, Inc.","filed_at":"2026-10-29T12:16:18+00:00","discovered_at":"2026-10-29T12:20:00.249508+00:00","generated_at":"2026-10-29T12:20:32.335960+00:00","sec_items":["2.02","7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rafael Holdings submits NDA for remibetadex in NPC; FY2026 net loss narrows to $29.6 million","bullets":["Cyclo Therapeutics, a Rafael Holdings subsidiary, submitted an NDA to the FDA for remibetadex (Trappsol Cyclo) in Niemann-Pick Disease Type C on October 28, 2026.","Phase 3 TransportNPC missed its primary endpoint (p=0.19) but showed 71% slowing of disease progression in patients on background therapy (p=0.046).","Overall survival analysis showed an 85% reduction in mortality risk for infantile-onset NPC versus matched registry controls (p=0.044); serious adverse events were 35.9% vs 16.7%.","Fiscal 2026 net loss was $29.6 million, or $0.58 per share, versus $30.5 million, or $1.04, a year earlier; cash was $22.1 million at July 31, 2026.","R&D rose to $24.3 million from $12.8 million, while G&A fell to $9.7 million from $13.8 million; remibetadex has Orphan Drug, Fast Track and Rare Pediatric Disease designations."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-113564","json":"https://secwatch.observer/filing/0001213900-26-113564.json","markdown":"https://secwatch.observer/filing/0001213900-26-113564.md","text":"https://secwatch.observer/filing/0001213900-26-113564.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1713863/000121390026113564/0001213900-26-113564-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1713863/000121390026113564/ea0309961-8k_rafael.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-29T12:20:32.335960+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"}