Radiopharm Theranostics Reports Quarterly Financial Results and Business Update

Radiopharm Theranostics Scheduled to Present at Deutsche Bank ADR Virtual Investor Conference

Radiopharm Theranostics Ltd. is scheduled to deliver a live presentation at the Deutsche Bank ADR Virtual Investor Conference on November 10, 2026.

Radiopharm Theranostics Announces Alignment with U.S. FDA on Single Pivotal Phase 3 Trial for RAD101 in Diagnosis of Brain Metastases

Radiopharm Theranostics received FDA alignment on a pivotal Phase 3 trial design for RAD101, a novel imaging agent for detecting brain metastases. The single multicenter trial will enroll approximately 280 patients and is substantially smaller than historical imaging studies, reflecting significant unmet medical need. The company expects to initiate the trial in the first half of 2027 with manufacturing support from Siemens Healthineers.

Radiopharm Theranostics Reports Business Update

Radiopharm Theranostics announced successful completion of an End-of-Phase 2 meeting with the FDA for RAD101, a brain metastases imaging agent that demonstrated 93% concordance with MRI. The company is preparing to initiate a pivotal Phase 3 trial in 1Q27 and has secured a manufacturing partnership with Siemens Healthineers. Additionally, Radiopharm reported positive Phase 1 imaging data for RAD301 in pancreatic cancer and advanced RAD202 to the fourth dosing cohort in its HER2+ solid tumor study.

Radiopharm Theranostics shares are trading lower after the company announced the completion of an End-of-Phase 2 meeting with FDA regarding RAD101.

Radiopharm Theranostics Announces Completion Of EOP2 Meeting With FDA Regarding RAD101, Investigational Radiopharmaceutical Imaging Agent For Detection Of Brain Metastases

Constructive FDA interaction provides clear framework for RAD101 pivotal clinical development plan in brain metastases imagingCurrently executing Phase 3 readiness activities in anticipation of FDA meeting minutes in

Radiopharm Says Data From Interim Analysis Of Phase 2b Imaging Clinical Trial Of 18F-RAD101 In Participants With Suspected Recurrent Brain Metastases From Solid Tumors Selected For Presentation At SNO26 Annual Meeting

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpointMeeting with FDA planned on October 1st to align on RAD101Phase 3 pivotal trial protocolBrain