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Rafael Holdings Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Corporate Update

Globe Newswire•29/10/2026•08:00 ET
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Key Highlights

  • ➤Remibetadex NDA submitted to FDA for Niemann-Pick Disease Type C treatment
  • ➤Phase 3 study missed primary endpoint overall; prespecified subgroup showed 71% slowing
  • ➤Fiscal 2026 net loss $29.6M, or $0.58 per share, versus $30.5M
  • ➤Cash and equivalents fell to $22.1M from $52.8M year over year
  • ➤Fiscal 2026 R&D expenses rose to $24.3M from $12.8M

NEWARK, N.J., Oct. 29, 2026 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL) today reported its financial results for the fourth quarter and full fiscal year 2026 ended July 31, 2026.

Fiscal 2026 and Recent Corporate Highlights * NDA submitted for remibetadex (Trappsol® Cyclo™). On October 28, 2026, Cyclo Therapeutics submitted a New Drug Application (NDA) to the FDA seeking approval of remibetadex for the treatment of Niemann-Pick Disease Type C. The NDA is supported by the Phase 3 TransportNPC™ study, completed in June 2026, which did not meet its primary endpoint in the overall population (p=0.19) but showed 71% slowing of disease progression in a prespecified analysis of patients receiving background miglustat and/or leucine therapy (p=0.046), and by an overall survival analysis versus matched registry controls. The NDA includes a request for a rare pediatric disease priority review voucher. * MIT license in Alzheimer’s disease. In April 2026, Cyclo entered into an exclusive, worldwide license with the Massachusetts Institute of Technology for the use of hydroxypropyl-β-cyclodextrin in Alzheimer’s disease. * LipoMedix. In June 2026, an investigator-initiated Phase II trial of Promitil® with radiotherapy in patients with cisplatin-ineligible head and neck cancer was launched in Israel. * Rafael Medical Devices. Continued the U.S. commercial build-out of the FDA-cleared VECTR™ System, including its regional distributor network. Rafael Holdings, Inc. Fourth Quarter Fiscal Year 2026 Financial Results

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