Radiopharm Theranostics Limited (Nasdaq: RADX; ASX: RAD) says it has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for October 1, 2026. The company plans to discuss the pivotal Phase 3 trial design for RAD101, its investigational imaging agent for suspected recurrent brain metastases following radiotherapy.
The meeting is expected to address the proposed number of participants and the study’s primary and secondary endpoints. Regulators will also review data from the completed RAD101 Phase 2b trial. Radiopharm aims to be ready for Phase 3 by the end of 2026, although the study’s final design and timing will depend on its discussions with the FDA.
RAD101 is a fluorine-18-labeled small-molecule PET imaging agent that targets fatty acid synthase, or FASN. Radiopharm is developing the candidate to help distinguish recurrent cancer from treatment-related changes in patients previously treated for brain metastases. This can be challenging when conventional MRI findings are inconclusive.
The candidate has received FDA Fast Track designation. However, that designation is intended to facilitate development and regulatory review; it does not represent approval of RAD101 or its proposed Phase 3 program.
The supporting Phase 2b study was a single-arm U.S. trial involving 30 people with confirmed recurrent brain metastases originating from solid tumors. Radiopharm reported 93% concordance between RAD101 PET imaging and MRI across evaluable lesions, meeting the trial’s primary endpoint.
The company also reported that an interim analysis involving 14 patients with six-month follow-up and biopsy data showed 86% sensitivity, representing 12 of 14 patients.
These findings remain preliminary evidence from a small, uncontrolled study. Concordance with MRI is not the same as demonstrating diagnostic accuracy across a large and diverse patient population. A larger registrational trial will be required to further evaluate RAD101’s performance and support any future regulatory application.
Radiopharm has partnered with Siemens Healthineers to manufacture and distribute fluorine-18 RAD101 doses for the planned U.S. Phase 3 study. CEO Riccardo Canevari described the FDA meeting as an “important milestone” toward advancing the program.
Financing remains an important consideration. In July, Radiopharm announced a US$4.1 million registered direct offering involving American Depositary Shares and warrants. The company also announced an Australian institutional placement and share-purchase plan. These transactions may provide capital for the RAD101 study and other clinical programs, but the associated shares, warrants and options create dilution risk for existing investors.
The principal near-term catalyst is the October 1 FDA meeting. Investors will be watching for the resulting Phase 3 patient count, endpoints, trial timing and funding requirements.
Sources
- Radiopharm Theranostics to Meet With U.S. FDA on RAD101 Phase 3 Trial Design — GlobeNewswire, August 17, 2026
- Radiopharm Theranostics Reports Business Update — Nasdaq, July 31, 2026
- Radiopharm Announces Concurrent U.S. and Australian Financing — GlobeNewswire, July 24, 2026
Editorial Disclosure
This article is based entirely on publicly available information, including company press releases, regulatory filings and publicly available clinical and market sources. Securities discussed or referenced include Radiopharm Theranostics Limited (Nasdaq: RADX; ASX: RAD). Biotech Stocks Daily has not received compensation from any company mentioned, its management, investor relations representatives or any third party for this specific article. Biotech Stocks Daily may have current or past paid business relationships with other companies, which do not influence the content or conclusions of this article. No staff member or principal of Biotech Stocks Daily holds a position in any security mentioned at the time of publication.
The cited announcements are company-issued disclosures and have not been independently validated by Biotech Stocks Daily. RAD101 remains investigational. The scheduled FDA meeting does not constitute approval of RAD101, its proposed Phase 3 design or a future marketing application. The Phase 2b study was small and single-arm, and its reported results may not be reproduced in a larger trial.
Radiopharm’s recent financing included American Depositary Shares, warrants, ordinary shares and proposed options. These securities may dilute existing shareholders. Clinical development also remains subject to regulatory alignment, financing availability, manufacturing capacity and operational execution.
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