{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-104876","form_type":"8-K","ticker":"RFL","cik":"0001713863","company_name":"Rafael Holdings, Inc.","filed_at":"2026-09-30T11:23:27+00:00","discovered_at":"2026-09-30T11:25:00.356669+00:00","generated_at":"2026-10-12T13:57:22.988847+00:00","sec_items":["7.01","2.02","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rafael Holdings' Trappsol Cyclo misses Phase 3 primary endpoint; NDA still on track for Q4 2026","bullets":["Phase 3 TransportNPC (CTD-TCNPC-301) in 94 NPC patients: Trappsol Cyclo slowed progression 64% on 4DNPCSS (LS mean 0.46 vs 1.28; difference -0.81; p=0.19), missing statistical significance.","Prespecified analysis of 78 patients on background miglustat and/or leucine (~83% of study) hit significance: 71% slowing (0.46 vs 1.57; difference -1.11; 95% CI -2.19 to -0.02; p=0.046).","Safety: TEAEs 93.8% Trappsol vs 100% placebo; serious TEAEs 35.9% vs 16.7%, but treatment-related serious TEAEs similar at 3.1% vs 3.3%; one severe bilateral deafness case.","Overall survival: infantile-onset patients (n=41) showed 85% mortality risk reduction vs 93 matched INPDR controls (HR=0.154, p=0.044); 94% reduction vs expanded controls (HR=0.057, p=0.0008).","NDA submission remains on track for Q4 2026 following a pre-NDA FDA meeting; full results to be presented at an upcoming medical meeting."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-104876","json":"https://secwatch.observer/filing/0001213900-26-104876.json","markdown":"https://secwatch.observer/filing/0001213900-26-104876.md","text":"https://secwatch.observer/filing/0001213900-26-104876.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1713863/000121390026104876/0001213900-26-104876-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1713863/000121390026104876/ea0307125-8k_rafael.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:57:22.988847+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"}