---
title: "Radiopharm schedules FDA end-of-Phase 2 meeting to align Phase 3 trial design for RAD101 brain metastases imaging agent"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/296102289.md"
description: "Radiopharm Theranostics scheduled an FDA end-of-Phase 2 meeting for Oct. 1, 2026, to align on Phase 3 trial design for RAD101, a PET imaging agent for brain metastases. Building on positive Phase 2b results, the Phase 3 trial will target patients with suspected recurrence post-radiotherapy. The company expects to be Phase 3-ready by year-end 2026, with Siemens Healthineers handling U.S. manufacturing and distribution."
datetime: "2026-08-17T12:03:13.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/296102289.md)
  - [en](https://longbridge.com/en/news/296102289.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/296102289.md)
generator: "portal-rs"
---

# Radiopharm schedules FDA end-of-Phase 2 meeting to align Phase 3 trial design for RAD101 brain metastases imaging agent

-   Radiopharm Theranostics scheduled an Oct. 1, 2026 FDA end-of-Phase 2 meeting to align on a pivotal Phase 3 trial for RAD101. \* Phase 2b results were already presented, supporting the diagnostic performance of the PET imaging agent in suspected recurrent brain metastases. \* The Phase 3 plan targets patients with suspected recurrence following radiotherapy, aiming to clarify disease versus treatment-related changes. \* Management expects to be Phase 3-ready by year-end 2026, setting up a registrational pathway for the imaging product. \* Siemens Healthineers will manufacture and distribute U.S. doses for the upcoming Phase 3 program, supporting trial execution and supply readiness. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Radiopharm Theranostics Ltd. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-26-090491), on August 17, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here

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