Rafael Holdings Reports Topline Phase 3 Results for Trappsol® Cyclo™

What Happened

• Rafael Holdings, Inc. (RFL) filed an 8‑K on September 30, 2026 to announce topline efficacy and safety data from Cyclo Therapeutics, LLC’s pivotal Phase 3 TransportNPC™ study (CTD‑TCNPC‑301) of Trappsol® Cyclo (intravenous hydroxypropyl‑β‑cyclodextrin) in 94 patients diagnosed with Niemann‑Pick Disease Type C (NPC). The company distributed a press release and posted it to its investor website; that press release is furnished as Exhibit 99.1 to the 8‑K.
• The filing also includes Item 2.02 (Results of Operations and Financial Condition) language noting the disclosure is furnished (not “filed”) and contains forward‑looking statements subject to the press release cautionary statements. The 8‑K was furnished under Regulation FD (Item 7.01).

Key Details

• Study: CTD‑TCNPC‑301 (TransportNPC™) — pivotal Phase 3 trial.
• Therapy: Trappsol® Cyclo (intravenous hydroxypropyl‑β‑cyclodextrin).
• Patients: Topline data reported from 94 NPC patients.
• Filing: 8‑K furnished September 30, 2026; press release included as Exhibit 99.1.

Why It Matters

• Topline Phase 3 results are a major clinical milestone for a potential therapy and are closely watched by investors and regulators. Rafael publicly shared these results via a press release, which the company furnished to the SEC under Regulation FD.
• The 8‑K does not attach financial figures in the filing text; it emphasizes the clinical data announcement and includes standard forward‑looking statement language. Investors should review the Exhibit 99.1 press release for the full topline details and monitor subsequent company disclosures for detailed efficacy/safety data and any regulatory plans.