Rafael Holdings, Inc. filed a Form 8-K with the SEC on October 29, 2026, disclosing both its fiscal quarter and fiscal year earnings release and an NDA submission by Cyclo Therapeutics, LLC to the FDA for remibetadex in the treatment of Niemann-Pick Disease Type C.

Key Highlights

  • NDA submitted: Cyclo Therapeutics, LLC has submitted a New Drug Application to the FDA seeking approval of remibetadex (Trappsol® Cyclo™) for the treatment of neurovisceral manifestations of Niemann-Pick Disease Type C (NPC) in adult and pediatric patients from birth.
  • New nonproprietary name assigned: The United States Adopted Names (USAN) Council has assigned the nonproprietary name "remibetadex" to the compound previously known as intravenous hydroxypropyl-β-cyclodextrin.
  • Rare disease indication: According to the filing, NPC is described as "a rare, fatal and progressive genetic disorder for which there is no known cure."
  • Earnings results announced: The company distributed an earnings release reporting results of operations for the fiscal quarter and fiscal year ended July 31, 2026.
  • Exchange listing: The company's Class B common stock, par value $0.01 per share, trades on NYSE:RFL.

Cyclo Therapeutics NDA Submission and Rafael Holdings Fiscal Year Results

Rafael Holdings, Inc. issued two press releases on October 29, 2026, both furnished as exhibits to this Form 8-K filing. The first, furnished as Exhibit 99.1, announced the company's results of operations for the fiscal quarter and fiscal year ended July 31, 2026. The second, furnished as Exhibit 99.2, announced a significant regulatory development involving Cyclo Therapeutics, LLC, an entity connected to the company.

According to the filing, Cyclo Therapeutics, LLC has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval of remibetadex, also identified as Trappsol® Cyclo™ and previously known as intravenous hydroxypropyl-β-cyclodextrin. The proposed indication is the treatment of the neurovisceral manifestations of Niemann-Pick Disease Type C in adult and pediatric patients from birth. The filing further states that the USAN Council has assigned the nonproprietary name "remibetadex" to the compound.

The filing notes that both press releases contain statements intended as "forward-looking statements" that are subject to the cautionary statements set forth in each press release. The information furnished under Items 2.02, 7.01, and 8.01 is stated in the filing as not deemed "filed" with the SEC unless otherwise expressly stated in a subsequent filing. The Form 8-K was signed by David Polinsky, Chief Financial Officer of Rafael Holdings, Inc., and dated October 29, 2026.

What Was Disclosed

Rafael Holdings filed an 8-K on October 29, 2026, disclosing two items: fiscal year and quarterly earnings results for the period ended July 31, 2026, and an NDA submission by Cyclo Therapeutics, LLC to the FDA for remibetadex to treat NPC, along with a new USAN-assigned nonproprietary name for the compound.