90% of patients dosed with RAD 101 and evaluable at interim analysis achieved concordance with MRI imaging (the primary endpoint) First five patients with available data from six-month follow-up and b...

Radiopharm Theranostics (ASX:RAD, 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.

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 meeting with the U.S. FDA scheduled for October 1...

Reported positive results from the Phase 2b clinical trial of imaging agent RAD 101, showing 93% of evaluable patients treated with RAD 101 achieved the primary endpoint Plans to initiate Phase 3 regi...

Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX) reported positive Phase 2b results for RAD101, an F‑18 PET imaging agent targeting FASN for diagnosing suspected recurrent brain metastases after stereotactic radiosurgery. In 30 evaluable patients, RAD101 PET showed 93% concordance with contrast-enhanced MRI across all assessed lesions, meeting the trial’s primary endpoint.Among 14 patients with six‑month follow-up and/or biopsy, preliminary sensitivity was 86% (12/14), a secondary objective; specificity data are expected in Q4 2026. Radiopharm plans to initiate a U.S. Phase 3 pivotal trial in Q4 2026, supported by an existing FDA Fast Track Designation and a U.S. manufacturing and distribution partnership with Siemens Healthineers for 18F‑RAD101. The company estimates a ~$600+ million total addressable market for imaging brain metastases, for which it notes there is currently no approved PET product.

Data from the interim analysis in Phase 2b trial of RAD101 showed significant and selective tumor uptake in brain metastases, with 90% concordance (Primary...

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Interim data to date showed 90% concordance with MRI (the primary endpoint) Clinical trial readout (Primary endpoint) expected in June 2026 Plans to advance RAD 101 into U.S. Phase 3 pivotal trial SYD...

Data from the interim analysis in Phase 2b trial of RAD101 showed significant and selective tumor uptake in brain metastases, with 90% concordance (Primary Endpoint) with MRI. Partnership ensures suff...

92% of evaluable patients at interim analysis treated with RAD 101 achieved concordance¹ with MRI imaging (the primary endpoint) with significant and selective tumor uptake in suspected or recurrent b...

Early patient data from Phase 2b clinical trial showed significant and selective tumor uptake in brain metastases compared to MRI Phase 2b clinical trial expected to complete enrollment and have topli...

RAD101 in U.S. Phase 2 clinical trial to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different originSYDNEY, June 11, 2025 (GLOBE NE...

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長野県松本市で開催の『りんご音楽祭2025』第11弾出演アーティスト4組を発表　りんごステージ、そばステージのタイムテーブルが解禁

長野県松本市にて9月27日（土）・28日（日）に開催される野外音楽フェス『りんご音楽祭2025』の第11弾出演アーティストとして4組が発表された。

長野県松本市にて9月27日（土）・28日（日）に開催される野外音楽フェス『りんご音楽祭2025』の第11弾出演アーティストとして4組が発表された。

Final patient dosing wraps a 30-person U.S. study of 18F-RAD101. Why it matters: June data will guide Radiopharm’s planned Phase 3 pivotal trial.

Radiopharm Theranostics (ASX:RADX) signed a U.S. supply agreement with Siemens Healthineers to radiolabel and distribute 18F‑RAD101 for upcoming trials. An interim Phase 2b analysis reported 90% concordance (18/20) between RAD101 PET imaging and MRI for brain metastases. The company holds FDA Fast Track designation and expects to start a multi‑center Phase 3 registrational trial in the U.S. after topline Phase 2b readout in H1 2026.