Clinical TrialJul 8, 2026, 04:56 PM
Rafael Holdings: Trappsol® Cyclo NDA & Topline Data H2 2026
AI Summary
Rafael Holdings, Inc. announced the availability of an investor presentation detailing the progress of its lead drug, Trappsol® Cyclo, for Niemann-Pick Disease Type C1. The Phase 3 trial completed its Last Patient Last Visit (LPLV) in June 2026, with an NDA submission and topline data expected in the second half of 2026. An independent Data Monitoring Committee recommended continuing the study after a June 2025 interim analysis. The company also highlighted the global NPC market potential and its $30.5 million cash balance as of April 30, 2026.
Key Highlights
- Trappsol® Cyclo Phase 3 trial for Niemann-Pick Disease Type C1 (NPC).
- Interim analysis in June 2025 recommended continuation to 96-week final analysis.
- Last Patient Last Visit (LPLV) completed in June 2026.
- NDA submission and topline data expected in 2nd half 2026.
- Global NPC market projected to exceed $920M by 2033.
- Company holds $30.5M in cash as of April 30, 2026.
- Endoscopic Carpal Tunnel Release system received FDA approval in December 2024.
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