---
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"
generated_at: "2026-10-29T12:20:32.335960+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-113564
- JSON: https://secwatch.observer/filing/0001213900-26-113564.json
- Plain text: https://secwatch.observer/filing/0001213900-26-113564.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.