RAD Alignment with US FDA for Development of RAD101

Nov 3, 2026 at 4:49 PM EST · Issued by Radiopharm Theranostics Limited via ASX

Filed with ASX · Nov 3, 2026 at 4:49 PM EST · 3 pages · English

On 6ix: 6ix.com/news/rad-alignment-with-us-fda-for-development-of-rad101-1

Release

ASX ANNOUNCEMENT 4 November 2026 Radiopharm Theranostics Announces Alignment with U.S. FDA on Single Pivotal Phase 3 Trial for RAD101 in Diagnosis of Brain Metastases Single, multicenter Phase 3 imaging trial of approximately 280 patients with brain metastases designed to demonstrate sensitivity...

Radiopharm Theranostics Limited on 6ix

Story so far

Radiopharm Completes Productive End-of-Phase 2 Meeting with U.S. Food and Drug Administration for Pivotal Development Program of RAD101Oct 5, 2026
RAD Completes Meeting with US FDA for Development of RAD101Oct 4, 2026
RAD to meet with US FDA to align on RAD 101 Phase 3 TrialAug 16, 2026

Earlier from Radiopharm Theranostics

Quarterly Activities/Appendix 4C Cash Flow ReportOct 30
Notice of Annual General Meeting/Proxy FormOct 26
Radiopharm receives $8M advance on FY26 R&D tax incentiveOct 26
Notification regarding unquoted securities - RADOct 20
Change of Director's Interest Notices x 4Oct 20

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