Radiopharm Secures FDA End-of-Phase 2 Meeting for RAD101, Phase 2b Shows 93% Concordance
RADX is trading near its 52-week low of $2.45 (4.9% above the low).
Summary
Radiopharm Theranostics announced an FDA End-of-Phase 2 meeting for RAD101 on October 1, 2026, following Phase 2b data showing 93% concordance with MRI. The company is on track to be Phase 3 ready by year-end.
Key Events · Product Development and Regulatory · RADX
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FDA End-of-Phase 2 Meeting Scheduled
An End-of-Phase 2 meeting with the U.S. FDA has been scheduled for October 1, 2026, to align on the pivotal Phase 3 trial design for RAD101 in brain metastases.
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Phase 2b Primary Endpoint Met
The Phase 2b trial demonstrated 93% concordance between MRI and PET imaging across all evaluable lesions, meeting the primary endpoint.
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Phase 3 Readiness by Year-End
The company is on track to be Phase 3 ready by year-end 2026, with the FDA meeting expected to finalize trial design criteria including patient numbers and endpoints.
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Siemens Healthineers Partnership
Siemens Healthineers will manufacture and distribute doses of 18F-labeled RAD101 to support the upcoming Phase 3 registrational trial in the U.S.
Analysis · RADX · Life Sciences
An End-of-Phase 2 meeting with the FDA has been scheduled for October 1, 2026, to align on the pivotal Phase 3 trial design for RAD101, the company's imaging agent for brain metastases. The Phase 2b trial met its primary endpoint with 93% concordance between MRI and PET imaging. This critical regulatory milestone de-risks the program and sets a clear path to Phase 3 readiness by year-end. A manufacturing partnership with Siemens Healthineers was also announced to support the upcoming trial. Given the company's tight cash position (A$4.1 million as of Q2 2026) and recent dilutive financings, this positive clinical and regulatory progress is a significant counterweight, potentially improving financing terms and investor sentiment.
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In the 30 days to Oct 19, 2026, 37.8% of the 898 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was -0.82%. These are measured outcomes after filings of this importance, not a forecast for this one.
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At the time of this filing, RADX was trading at $2.57 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $33.8M. The 52-week trading range was $2.45 to $16.25. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.