---
title: "Rafael Holdings: Phase 3 LPLV complete; NDA submission and topline expected 2H 2026"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/292114512.md"
description: "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."
datetime: "2026-07-08T20:53:01.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/292114512.md)
  - [en](https://longbridge.com/en/news/292114512.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/292114512.md)
generator: "portal-rs"
---

# Rafael Holdings: Phase 3 LPLV complete; NDA submission and topline expected 2H 2026

**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

**Disclaimer**

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.

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---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**