Class B common stock, par value $0.01 per share
- Symbol
- RFL
- Exchange
- NYSE
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
Rafael Holdings, Inc.
RFLNYSEEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01. Regulation FD On September 30, 2026, Rafael Holdings, Inc. (the “Company”) distributed over a wire service and posted the attached press release (the “Release”) to the investors page of the Company’s website (www.rafaelholdings.com) announcing topline efficacy and safety data from its Cyclo Therapeutics, LLC subsidiary’s pivotal Phase 3 TransportNPC™ study (CTD-TCNPC-301) evaluating Tra…
Company context
Rafael Holdings, Inc. is a biotechnology company that develops pharmaceuticals and holds interests in clinical and early-stage companies that develop pharmaceuticals and medical devices. Our lead candidate is Trappsol® Cyclo™, and we have completed a pivotal Phase 3 study in NPC and are preparing for a planned NDA submission later this year. Niemann-Pick Disease Type C (“NPC”) is a rare, fatal and progressive genetic disorder. We also hold interests in other clinical-stage and early-stage pharmaceutical development companies and an orthopedic-focused medical device company.
Current securities
Historical securities (1)
Registered securities in this filing
RAFAEL HOLDINGS, INC. · 8-K · Filed 2026-09-30
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation
FD
On September 30, 2026,
Rafael Holdings, Inc. (the “Company”) distributed over a wire service and posted the attached press release (the “Release”)
to the investors page of the Company’s website (www.rafaelholdings.com) announcing
topline efficacy and safety data from its Cyclo Therapeutics, LLC subsidiary’s pivotal Phase 3 TransportNPC™ study (CTD-TCNPC-301)
evaluating Trappsol® Cyclo™ (intravenous hydroxypropyl-β-cyclodextrin) in 94 patients diagnosed with Niemann-Pick Disease
Type C (NPC).
A copy of the Release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The Company is furnishing the information contained in this Report, including Exhibit 99.1, pursuant to Item 2.02 of Form 8-K promulgated by the Securities and Exchange Commission (the “SEC”). This information shall not be deemed to be “filed” with the SEC or incorporated by reference into any other filing with the SEC unless otherwise expressly stated in such filing. In addition, this Report and the press release contain statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in the press release.
Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events.
The information contained in Item 7.01 above is incorporated herein by reference into this Item 8.01.
Filed exhibits (1)
Exhibit 99.1 Rafael Holdings Announces Topline Results from the Pivotal Phase 3 TransportNPC ™ Study of Trappsol ® Cyclo ™ in Niemann-Pick Disease Type C (NPC) Trappsol® Cyclo™ did not achieve statistical significance but demonstrated a directionally favorable treatment effect versus placebo on the primary endpoint of change in the 4-domain NPC Clinical Severity Scale (4DNPCSS) at Week 96 A prespecified analysis in patients receiving background miglustat and/or leucine therapy, representing approximately 83% of the study population, showed a statistically significant effect on the 4DNPCSS Trappsol® Cyclo™ demonstrated a well-tolerated safety and tolerability profile consistent with previous studies, with no new safety signals observed Based upon its previously announced pre-NDA meeting, the Company remains on track to submit the NDA in the fourth quarter of 2026, consistent with prior guidance Company to host investor conference call and webcast today, September 30, at 8:30 a.m. ET NEWARK, NJ - September 30, 2026 - Rafael Holdings, Inc. (NYSE: RFL) today announced topline efficacy and safety data from its Cyclo Therapeutics, LLC subsidiary’s pivotal Phase 3 TransportNPC™ stu…
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