---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-067083"
form_type: "8-K"
ticker: "RFL"
cik: "0001713863"
company_name: "Rafael Holdings, Inc."
filed_at: "2026-06-10T11:49:05+00:00"
generated_at: "2026-06-10T11:50:08.159617+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Rafael Holdings announces Phase 3 TransportNPC study completion; NDA submission targeted H2 2026

## Summary
- Last patient completed final 96-week visit in pivotal Phase 3 TransportNPC study for Trappsol Cyclo in Niemann-Pick Disease Type C.
- Topline data from main cohort expected to be announced in second half of calendar 2026.
- Pre-NDA meeting with FDA completed; NDA submission expected in second half of 2026.
- FDA acknowledged US Expanded Access Program (EAP) can proceed.
- Pediatric sub-study (0-3 years) data: 80% of patients improved or stable with no serious related adverse events.

## SEC filing metadata
- accession: 0001213900-26-067083
- form_type: 8-K
- ticker: RFL
- cik: 0001713863
- company_name: Rafael Holdings, Inc.
- filed_at: 2026-06-10T11:49:05+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1713863/000121390026067083/0001213900-26-067083-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1713863/000121390026067083/ea0294151-8k_rafael.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-067083
- JSON: https://secwatch.observer/filing/0001213900-26-067083.json
- Plain text: https://secwatch.observer/filing/0001213900-26-067083.txt

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