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

Rafael Holdings submits NDA for remibetadex; Q4 net loss narrows to $9.2 million

Mixed Impact 4 of 5 product/contract Written later

Rafael Holdings reported fourth-quarter and fiscal 2026 results for the period ended July 31, 2026, and said its subsidiary Cyclo Therapeutics submitted a New Drug Application to the FDA for remibetadex to treat Niemann-Pick Disease Type C. The Phase 3 study did not meet its primary endpoint in the overall population, and the company cites substantial doubt about its ability to continue as a going concern and its need for additional financing. The quarterly net loss narrowed while quarterly revenue declined slightly.

Key points

  • NDA submitted to the FDA on October 28, 2026; the FDA has 60 days to decide whether it is filed.
  • Phase 3 TransportNPC study missed its primary endpoint in the overall population (p=0.19); a prespecified subgroup showed a 71% slowing of disease progression (p=0.046).
  • Q4 net loss attributable to Rafael Holdings was $9.2 million, or $0.18 per share, versus $12.1 million, or $0.28 per share, a year earlier.
  • Q4 revenue was $244,000 versus $350,000 a year earlier; cash and cash equivalents were $22.1 million as of July 31, 2026.

The filing

CompanyRafael Holdings, Inc. (RFL)
Form8-K, current report
Filed with the SECOct 29, 2026, 8:16 AM ET
Accession number0001213900-26-113564

Items reported: 2.02 Results of Operations7.01 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 October 29, 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.