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Radiopharm Theranostics Limited (ASX:RAD)

ALERT: Price-sensitive ASX Announcement for RAD
Current share price for RAD : $0.006 -0.006 (-50%)+
Announcement
Release
17 Aug 2026 9:02AM
Price at Release
$0.011
Full Release
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Summary
Radiopharm Theranostics Limited has announced an upcoming End-of-Phase 2 meeting with the US FDA scheduled for October 1, 2026. The meeting aims to align on the pivotal Phase 3 clinical trial design for RAD101, a novel imaging agent targeting fatty acid synthase (FASN) to diagnose recurrent brain metastases. The Phase 2b trial of RAD101 showed a 93% concordance with MRI, meeting its primary endpoint. The FDA has granted RAD101 a Fast Track Designation to distinguish between recurrent disease and treatment effects in brain metastases. The company is poised to be Phase 3 ready by year-end 2026 and has partnered with Siemens Healthineers for production and distribution of the agent.
Key Points
  • End-of-Phase 2 meeting with US FDA scheduled for October 1, 2026.
  • RAD101 Phase 2b trial showed 93% concordance with MRI.
  • RAD101 targets fatty acid synthase (FASN) to diagnose recurrent brain metastases.
  • RAD101 received FDA Fast Track Designation.
  • Partnership with Siemens Healthineers for production and distribution.
  • On track to be Phase 3 ready by year-end 2026.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.