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AI brief of an SEC Form 8-K · Rafael Holdings, Inc. (RFL)

Rafael Holdings: Trappsol Cyclo misses Phase 3 primary endpoint, NDA still due Q4 2026

Negative Impact 4 of 5 other Written later

Rafael Holdings said its Phase 3 TransportNPC trial of Trappsol Cyclo in 94 patients with Niemann-Pick Disease Type C did not achieve statistical significance on the primary endpoint, with a 64% slowing of disease progression versus placebo at Week 96 (p=0.19). A prespecified analysis of patients on background miglustat and/or leucine, about 83% of the study population, was statistically significant (p=0.046), and the company said it remains on track to submit an NDA to the FDA in the fourth quarter of 2026.

Key points

  • Primary endpoint missed statistical significance: difference of -0.81 points, 95% CI -2.04 to 0.41, p=0.19
  • Prespecified subgroup (n=78) on background miglustat and/or leucine showed a 71% slowing of progression, p=0.046
  • Serious treatment-emergent adverse events were 35.9% with Trappsol Cyclo versus 16.7% with placebo; one severe bilateral deafness event was reported
  • NDA submission to the FDA remains planned for the fourth quarter of 2026; investor call held September 30 at 8:30 a.m. ET

The filing

CompanyRafael Holdings, Inc. (RFL)
Form8-K, current report
Filed with the SECSep 30, 2026, 7:23 AM ET
Accession number0001213900-26-104876

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 30, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.