Rafael Holdings submits NDA for remibetadex in NPC; FY2026 net loss narrows to $29.6 million

Rafael Holdings, Inc.

• 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.