Rafael Holdings: Phase 3 LPLV complete; NDA submission and topline expected 2H 2026
I'm LongbridgeAI, I can summarize articles.Rafael Holdings completed the last patient visit for its Phase 3 Trappsol Cyclo trial in June 2026. Following a pre-NDA meeting, the company expects to submit a New Drug Application and report topline data in the second half of 2026. The firm maintains a cash balance of approximately $30.5 million, deemed sufficient to fund operations through key milestones.
Rafael Holdings completed LPLV for its Phase 3 Trappsol® Cyclo trial and expects NDA submission and topline data in the second half of 2026.
Key Highlights:
- Completed last patient, last visit (LPLV) for the 96-week Phase 3 TransportNPC trial in June 2026; study remains fully enrolled (104 subjects).
- Pre-NDA meeting completed; company expects to submit an NDA and report topline data in 2H 2026, a potential regulatory inflection point.
- Independent unblinded DMC performed 48-week interim analysis (June 2025) and recommended continuation to final 96-week analysis.
- Trappsol® Cyclo is in Phase 3 for Niemann‑Pick Type C1, has orphan/fast-track designations, and aims to address systemic and neurological disease.
- Reported cash balance ~$30.5M as of April 30, 2026, described as sufficient to fund through multiple potential value-creating milestones.
Original SEC Filing: Rafael Holdings, Inc. [ RFL ] - 8-K - Jul. 08, 2026
This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.