Every material Form 8-K Rafael Holdings, Inc. has filed with the SEC since July 08, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Rafael Holdings furnished an November 2026 investor presentation under Regulation FD, posted on its website from November 9, 2026. The deck restates that the pivotal Phase 3 TransportNPC study for remibetadex missed its primary endpoint, with a 64% slowing of disease progression versus placebo that was not statistically significant (p=0.19), and that a New Drug Application was submitted in October 2026. The filing also cites substantial doubt about the company's ability to continue as a going concern and its need for additional capital.
Primary endpoint: 64% slowing of disease progression versus placebo, difference −0.81 (p=0.19), described as not statistically significant; a prespecified subgroup analysis reached p=0.046.
Serious treatment-emergent adverse events: 35.9% of remibetadex participants versus 16.7% on placebo over 96 weeks.
NDA submitted October 2026; Day 60 FDA filing decision expected December 27, 2026; potential FDA action around mid-2027 if priority review is granted.
Cash balance of $22.1 million as of July 31, 2026; the forward-looking statements cite going concern doubt and need for additional capital.
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.
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.
Rafael Holdings said its Phase 3 TransportNPC trial of Trappsol Cyclo in 94 patients with Niemann-Pick Disease Type C did not achieve statistical significance on the primary endpoint, with a 64% slowing of disease progression versus placebo at Week 96 (p=0.19). A prespecified analysis of patients on background miglustat and/or leucine, about 83% of the study population, was statistically significant (p=0.046), and the company said it remains on track to submit an NDA to the FDA in the fourth quarter of 2026.
Primary endpoint missed statistical significance: difference of -0.81 points, 95% CI -2.04 to 0.41, p=0.19
Prespecified subgroup (n=78) on background miglustat and/or leucine showed a 71% slowing of progression, p=0.046
Serious treatment-emergent adverse events were 35.9% with Trappsol Cyclo versus 16.7% with placebo; one severe bilateral deafness event was reported
NDA submission to the FDA remains planned for the fourth quarter of 2026; investor call held September 30 at 8:30 a.m. ET
Rafael Holdings furnished a July 2026 investor presentation under Regulation FD, posted on its website from July 8, 2026. The deck says the Phase 3 trial of Trappsol Cyclo completed its last patient last visit in June 2026, with NDA submission and topline data expected in the second half of 2026, and it cites a cash balance of about $30.5 million as of April 30, 2026.
Phase 3 trial of Trappsol Cyclo for Niemann-Pick Disease Type C1 completed last patient last visit in June 2026
NDA submission and topline data expected in the second half of 2026
Cash balance of about $30.5 million as of April 30, 2026
Trial enrolled 104 subjects: 94 in the core study and 10 in the sub-study
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