secwatch.observer — SEC 8-K summary
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Issuer:     Rafael Holdings, Inc. (RFL)
CIK:        0001713863
Form:       8-K
Filed at:   2026-06-10T11:49:05+00:00
Accession:  0001213900-26-067083
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1713863/000121390026067083/0001213900-26-067083-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1713863/000121390026067083/ea0294151-8k_rafael.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-067083

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer