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Form SCHEDULE 13G Radiopharm Theranostics Filed by: Regal Partners Funds Management Pty Ltd

Wed, 14 Oct 2026 21:16:00 -0400

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Radiopharm completes FDA end-of-phase 2 meeting for RAD101

Mon, 05 Oct 2026 08:01:57 -0400

Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) announced the completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding RAD101, its investigational radiopharmaceutical imaging agent for the detection of brain metastases.

RAD101 is a Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from solid tumors. Phase 2b clinical trial data previously showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint.

The company said it expects to receive the FDA's official meeting minutes within approximately 30 days, which will

Radiopharm Completes Productive End-of-Phase 2 Meeting with U.S. Food and Drug Administration for Pivotal Development Program of RAD101

Mon, 05 Oct 2026 08:00:00 -0400

Constructive FDA interaction provides clear framework for RAD101 pivotal clinical development plan in brain metastases imaging

Currently executing Phase 3 readiness activities in anticipation of FDA meeting minutes in next 30 days

SYDNEY, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics Limited (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage radiopharmaceutical company, today announced the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA or the Agency) regarding RAD101, the Company's investigational radiopharmaceutical imaging agent for the detection of brain metastases.

RAD101 is the

Radiopharm Completes Productive End-of-Phase 2 Meeting with U.S. Food and Drug Administration for Pivotal Development Program of RAD101

Mon, 05 Oct 2026 08:00:00 -0400

Constructive FDA interaction provides clear framework for RAD101 pivotal clinical development plan in brain metastases imaging

Currently executing Phase 3 readiness activities in anticipation of FDA meeting minutes in next 30 days

RAD101 is the

Form 6-K Radiopharm Theranostics For: Oct 05

Mon, 05 Oct 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Oct 01

Thu, 01 Oct 2026 08:00:00 -0400

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Form 20-F Radiopharm Theranostics For: Jun 30

Wed, 30 Sep 2026 15:16:00 -0400

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Form 6-K Radiopharm Theranostics For: Sep 30

Wed, 30 Sep 2026 06:08:00 -0400

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Form EFFECT Radiopharm Theranostics

Thu, 24 Sep 2026 06:02:00 -0400

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Form 424B3 Radiopharm Theranostics

Wed, 23 Sep 2026 16:50:00 -0400

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Form 6-K Radiopharm Theranostics For: Sep 22

Tue, 22 Sep 2026 08:00:00 -0400

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Radiopharm RAD101 brain imaging data selected for SNO26 presentation

Mon, 14 Sep 2026 08:02:22 -0400

Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) announced that interim data from its Phase 2b imaging trial of RAD101, a PET imaging agent for suspected recurrent brain metastases, has been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology, scheduled for November 12-15, 2026 in Philadelphia.

The interim analysis showed 93% concordance between RAD101 PET imaging and MRI across all evaluable lesions, meeting the trial's primary endpoint. Among 14 patients with evaluable six-month follow-up and/or biopsy data, preliminary sensitivity was 86%. The trial is a U.S. multi-center, open-label, single-arm Phase 2b study enrolling 30 evaluable

Radiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual Meeting

Mon, 14 Sep 2026 08:00:00 -0400

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint

Meeting with FDA planned on October 1st to align on RAD101Phase 3 pivotal trial protocol

Brain Metastases Imaging has ~$600 million total addressable market, and there are no currently approved PET products

SYDNEY, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that positive data from an interim

Radiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual Meeting

Mon, 14 Sep 2026 08:00:00 -0400

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint

Meeting with FDA planned on October 1st to align on RAD101Phase 3 pivotal trial protocol

Brain Metastases Imaging has ~$600 million total addressable market, and there are no currently approved PET products

Form 6-K Radiopharm Theranostics For: Sep 14

Mon, 14 Sep 2026 06:11:00 -0400

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Form F-3 Radiopharm Theranostics

Mon, 14 Sep 2026 06:09:00 -0400

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Form 6-K Radiopharm Theranostics For: Sep 11

Fri, 11 Sep 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 28

Fri, 28 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 28

Fri, 28 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 28

Fri, 28 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 27

Thu, 27 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 27

Thu, 27 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 27

Thu, 27 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 26

Wed, 26 Aug 2026 08:00:00 -0400

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Form 6-K Radiopharm Theranostics For: Aug 26

Wed, 26 Aug 2026 08:00:00 -0400

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