secwatch.observer — SEC 8-K summary
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Issuer:     Rafael Holdings, Inc. (RFL)
CIK:        0001713863
Form:       8-K
Filed at:   2026-10-29T12:16:18+00:00
Accession:  0001213900-26-113564
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1713863/000121390026113564/0001213900-26-113564-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1713863/000121390026113564/ea0309961-8k_rafael.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-113564

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