Aug. 18 at 5:47 PM
Radiopharm Theranostics Nasdaq:
$RADX has scheduled an End-of-Phase 2 meeting with the U.S. FDA on October 1, 2026 to align on the design of a pivotal Phase 3 trial of RAD101 in patients with suspected recurrent brain metastases following radiotherapy.
According to the company, its Phase 2b trial of RAD101 showed 93% concordance between MRI and PET imaging across evaluable lesions, meeting the primary endpoint and demonstrating substantial, selective tumor uptake. RAD101 has FDA Fast Track Designation, and a partnership with Siemens Healthineers will supply 18F-labeled RAD101 for the planned U.S. Phase 3 registrational trial, which Radiopharm aims to have Phase 3-ready by year-end 2026.
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