Radiopharm Theranostics Completes Enrollment in Phase 2b Trial for Brain Metastases Diagnostic RAD 101
RADX sits 24% above its 52-week low of $3.62 on light trading volume (0.1× avg).
Summary
Radiopharm Theranostics has completed patient enrollment in its U.S. Phase 2b imaging trial for RAD 101, a diagnostic for recurrent brain metastases, with full data readout expected in June 2026.
Key Events · Product Development and Regulatory · RADX
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Phase 2b Enrollment Completed
Radiopharm Theranostics has completed patient enrollment in its U.S. Phase 2b imaging trial (NCT06777433) for RAD 101, a diagnostic for recurrent brain metastases.
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Positive Interim Data Reported
Interim results from the trial showed 90% concordance with MRI, the primary endpoint, reinforcing confidence in RAD 101's potential.
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Full Data Readout and Phase 3 Plans
The full clinical trial data readout is anticipated in June 2026, with the company planning to advance RAD 101 into a U.S. Phase 3 pivotal trial.
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FDA Fast Track Designation
RAD 101 previously received FDA Fast Track Designation for distinguishing recurrent disease from treatment effect of brain metastases.
Analysis · RADX · Life Sciences
The completion of enrollment in the Phase 2b trial for RAD 101 marks a significant clinical milestone for Radiopharm Theranostics. This diagnostic candidate, which targets fatty acid synthase (FASN) and has FDA Fast Track Designation, showed 90% concordance with MRI in interim data. The company's plan to advance RAD 101 into a Phase 3 pivotal trial, following the expected full data readout in June, indicates strong confidence in its potential to address a critical unmet need in detecting brain metastases. This progress could significantly de-risk the program and represents a positive step towards potential commercialization for the small-cap biotech.
At the time of this filing, RADX was trading at $4.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $53.4M. The 52-week trading range was $3.62 to $16.25. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.