RAD101 Phase 2b Hits Primary Endpoint; Late-Breaking SNO26 Slot and FDA Meeting Set
RADX is trading near its 52-week low of $1.98 (1.0% below the low).
Summary
RAD101's Phase 2b imaging trial met its primary endpoint with 93% MRI concordance, was selected for a late-breaking SNO26 oral presentation, and an FDA meeting is set for October 1 to align on Phase 3.
Key Events · Product Development and Regulatory · RADX
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Phase 2b Primary Endpoint Met
RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions in the U.S. Phase 2b imaging trial (NCT06777433), meeting the trial's primary endpoint.
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Late-Breaking SNO26 Oral Presentation
The interim analysis data was selected for a late-breaking oral presentation at the Society of Neuro-Oncology Annual Meeting (SNO26) in Philadelphia, November 12-15, 2026.
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FDA Phase 3 Alignment Meeting
A meeting with the FDA is planned for October 1, 2026 to align on the RAD101 Phase 3 pivotal trial protocol, with Siemens Healthineers already signed to manufacture and distribute 18F-RAD101 doses.
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Preliminary Sensitivity Data
In 14 patients with evaluable six-month follow-up and/or biopsy data, RAD101 showed preliminary 86% sensitivity, a strong positive trend on a secondary objective.
Analysis · RADX · Life Sciences
Radiopharm's RAD101 imaging agent met its Phase 2b primary endpoint with 93% concordance against MRI, and the data earned a late-breaking oral slot at SNO26. The company also confirmed an FDA meeting on October 1 to align on a Phase 3 protocol, with Siemens Healthineers already signed to manufacture and distribute doses. This is the first hard efficacy readout for RAD101 and materially de-risks the program ahead of pivotal development. Against a backdrop of a going-concern warning and only A$4.14M in cash reported two weeks ago, positive data and a clear regulatory path are exactly what the company needs to support its A$18.5M capital raise and extend runway.
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At the time of this filing, RADX was trading at $1.96 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $24.9M. The 52-week trading range was $1.98 to $16.25. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.