Here are the 8-K filings from Rafael Holdings, Inc. (RFL) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
An 8-K covers material events a company has to report between its quarterly reports, so if you follow RFL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full RFL filings page.
Rafael Holdings, Inc. reported fiscal 2026 results and said subsidiary Cyclo Therapeutics, LLC submitted an NDA to the FDA seeking approval of remibetadex for the neurovisceral manifestations of Niemann-Pick disease type C (NPC) in patients from birth. Cash and cash equivalents were $22.1 million as of July 31, 2026. Fourth-quarter net loss attributable to Rafael Holdings was $9.2 million versus $12.1 million a year earlier; full-year net loss was $29.6 million versus $30.5 million.
The TransportNPC Phase 3 study did not achieve statistical significance on its primary endpoint; remibetadex showed a directionally favorable 64% relative slowing of disease progression versus placebo (p=0.19). A prespecified analysis of patients receiving background therapy reported 71% relative slowing (p=0.046). A survival analysis associated remibetadex with an 85% reduction in mortality risk for patients with infantile-onset NPC versus matched registry controls (p=0.044). Serious adverse events occurred in 35.9% with remibetadex and 16.7% with placebo.
Within 60 days of receiving the NDA, the FDA will determine whether it is filed and, if filed, whether Priority Review is granted; if filed, the agency will assign a PDUFA target action date. Remibetadex remains investigational and has not been FDA-approved. Rafael cited a need for additional financing and substantial doubt about its ability to continue as a going concern.
Rafael Holdings, Inc. (RFL) reported topline results from its subsidiary Cyclo Therapeutics’ pivotal Phase 3 TransportNPC study of Trappsol Cyclo in 94 patients with Niemann-Pick disease type C. At Week 96, the treatment showed a directionally favorable effect on the primary 4-domain NPC Clinical Severity Scale endpoint, but did not achieve statistical significance. A prespecified analysis of patients receiving background miglustat and/or leucine—approximately 83% of participants—showed a statistically significant effect.
Over 96 weeks, serious treatment-emergent adverse events were reported in 35.9% of Trappsol Cyclo participants versus 16.7% on placebo; treatment-related serious events were 3.1% versus 3.3%. No treatment-emergent adverse events resulted in death, and one treatment-related case of bilateral deafness was severe. A separate analysis comparing infantile-onset patients treated across the clinical program with matched external registry controls was described as supportive evidence of a treatment-associated survival benefit. Rafael said it remains on track to submit an NDA in the fourth quarter of 2026 following a previously announced pre-NDA meeting; the topline data, complete dataset and survival analysis remain subject to full analysis and FDA regulatory review.
Rafael Holdings, Inc. furnished an investor presentation outlining progress of its lead drug candidate Trappsol® Cyclo for Niemann-Pick Disease Type C1 (NPC). The company is running a fully enrolled, global Phase 3 trial with 104 subjects in a 96-week study using 2000 mg/kg intravenous dosing every two weeks.
The Phase 3 interim analysis at 48 weeks in June 2025 led an independent data monitoring committee to recommend continuation to the 96-week final analysis. Last-patient-last-visit and a pre-NDA meeting were completed in June 2026, and the company expects New Drug Application submission and topline Phase 3 data in the second half of 2026.
The presentation highlights prior Phase 1/2 data showing stabilized or improved clinical scores in most completers, a safety profile characterized mainly by mild to moderate adverse events, and regulatory designations including Orphan Drug status in the US and EU, Fast Track in the US, and Rare Pediatric Disease designation that may qualify for a Priority Review Voucher. It also cites estimates that the global NPC market could exceed $920m by 2031.
Rafael Holdings, Inc. reported third quarter fiscal 2026 results and highlighted a major clinical milestone: completion of the last patient last visit in its pivotal Phase 3 TransportNPC™ trial in Niemann-Pick Disease Type C1. Following a pre-NDA meeting, the company expects to submit an NDA in the second half of calendar 2026.
For the quarter ended April 30, 2026, Rafael Holdings posted a net loss attributable to the company of $4.2 million, or $0.08 per share, compared with a $4.8 million loss, or $0.19 per share, a year earlier. Revenue was $0.2 million versus $0.4 million in the prior-year quarter. Research and development expenses rose to $4.9 million from $3.0 million, reflecting the Cyclo acquisition, while general and administrative costs declined to $2.1 million from $3.2 million. As of April 30, 2026, the company held $30.5 million in cash and cash equivalents and total assets of $92.0 million.
Rafael Holdings, Inc. announced that the last patient has completed the final 96‑week visit in its pivotal Phase 3 TransportNPC™ study of Trappsol® Cyclo™ for Niemann‑Pick Disease Type C. The trial enrolled 94 patients across 27 sites in 13 countries, plus a 10‑patient pediatric sub‑study.
Topline data from the main study cohort are expected in the second half of 2026. The company has already held a pre‑NDA meeting with the FDA and expects to submit a New Drug Application in the second half of 2026. The FDA has also acknowledged that the company’s U.S. Expanded Access Program can proceed.
Rafael Holdings announced that its subsidiary Cyclo Therapeutics has entered into an exclusive licensing agreement with MIT for U.S. Patent No.12285440, covering the use of cyclodextrins in Alzheimer’s Disease patients who carry the ApoE4 genetic mutation.
The company plans to apply this patent to its lead candidate Trappsol® Cyclo™, which is already in a pivotal Phase 3 trial for Niemann-Pick Disease Type C1. The ApoE4 gene variant is estimated to be present in 50-70% of Alzheimer’s patients, and the release highlights preclinical data suggesting Trappsol® Cyclo™ may improve cholesterol transport in the brain, reduce tau pathology, and improve learning and memory in mice. Management also notes Phase 3 results from the Transport NPC study are expected in calendar Q3 2026.
Rafael Holdings, Inc. reported results for its second quarter of fiscal 2026, ended January 31, 2026, while highlighting progress in its pivotal Phase 3 TransportNPC™ study of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1. An independent Data Monitoring Committee recommended the trial continue after reviewing prespecified safety and efficacy data at 48 weeks, and the company expects to complete the 96-week study and report preliminary top line results in the third quarter of this calendar year.
As of January 31, 2026, cash and cash equivalents were $37.8 million, down from $52.8 million as of July 31, 2025. For the quarter, net loss attributable to Rafael Holdings was $6.4 million, or $0.13 per share, compared with a net loss of $4.6 million, or $0.19 per share, a year earlier. Revenue was $0.2 million, up from $0.1 million in the prior-year quarter, while research and development expenses rose to $4.5 million from $0.9 million, primarily due to consolidating Cyclo Therapeutics’ costs after its March 2025 acquisition. General and administrative expenses decreased to $2.3 million from $2.6 million.
Rafael Holdings, Inc. reported the results of its Annual Meeting of Stockholders held on January 8, 2026. All nominees for the Board of Directors were elected to one-year terms, each receiving around 5.2 million votes for and support levels above 84% of votes cast.
Stockholders also ratified the appointment of CohnReznick LLP as independent registered public accounting firm for the fiscal year ending July 31, 2026, with 6,064,445 votes for and 99.13% support. In addition, they approved an amendment to the 2021 Equity Incentive Plan to increase the Class B common stock available for awards by 1,000,000 shares, with 5,037,413 votes for and 82.34% support.
Rafael Holdings, Inc. reported that it has released its financial results for the fiscal quarter ended October 31, 2025. On December 11, 2025, the company distributed an earnings press release over a wire service and posted it on the investor section of its website.
The press release is furnished as Exhibit 99.1 to this Form 8-K and is described as announcing the company’s results of operations and financial condition for the quarter. Rafael Holdings notes that the information in this report and Exhibit 99.1 is being furnished, not filed, which affects how it may be used in other SEC filings. The company also indicates that the materials contain forward-looking statements that are subject to the cautionary language included in the press release.
Rafael Holdings, Inc. describes warrant terms issued in connection with its merger with Cyclo Therapeutics, Inc. The company issued 1,078,796 warrants that are exercisable for an aggregate of 380,253 shares of its Class B common stock at an exercise price of $14.19 per share. The warrants trade on NYSE American under the symbol RFL-WT and were issued in exchange for Cyclo warrants from a prior public offering. Each warrant is exercisable for approximately 0.3525 of a share of Class B common stock, reflecting the merger exchange ratio, and may be exercised at any time until they expire at 5:00 p.m. EST on December 11, 2025.
Rafael Holdings (RFL) furnished an 8‑K announcing it issued an earnings press release for the fiscal quarter and fiscal year ended July 31, 2025. The release was distributed via wire and posted on the company’s website, and is included as Exhibit 99.1. The information is furnished under Item 2.02 and is not deemed filed. The materials also contain forward‑looking statements accompanied by cautionary language.
Rafael Holdings appointed Alan Grayson to its Board on October 23, 2025, and to the Compensation, Corporate Governance and Nominating committees. Director Markus Sieger was named to the audit committee and elected its Chairman. These appointments fill vacancies following the recent passing of Stephen Greenberg. A press release dated October 28, 2025, was filed as Exhibit 99.1.
Rafael Holdings, Inc. filed a current report to let investors know that a new slide presentation is available. The investor presentation, labeled Exhibit 99.1, is accessible on the company’s website at https://rafaelholdings.irpass.com/ starting October 10, 2025.
The material is furnished under Regulation FD, which is meant to provide fair disclosure of information. The company specifies that this information is not considered formally filed with the SEC or incorporated into other SEC documents. The presentation also includes forward-looking statements that are subject to the cautionary language contained within the slides.