Recent Updates — RDPTF
Radiopharm Theranostics reached alignment with the U.S. Food and Drug Administration (FDA) on the design of a pivotal, multicenter Phase 3 imaging trial for its investigational agent RAD101. The study will enroll approximately 280 patients with indeterminate brain metastases following radiotherapy to evaluate sensitivity and specificity against a reference standard. This single-trial approach is substantially smaller than historical registrational studies for similar agents. The company has partnered with Siemens Healthineers to manufacture clinical supply of the 18F-labeled tracer and expects to complete CRO selection in late 2026, initiating dosing in the first half of 2027. RAD101 targets fatty acid synthase (FASN) to improve detection of cancer cells in the central nervous system. Radiopharm Theranostics is a clinical-stage biopharmaceutical company developing innovative oncology radiopharmaceuticals for diagnostic and therapeutic applications.
Radiopharm Theranostics Limited is seeking shareholder approval at its Annual General Meeting on November 25, 2026, to renew the Omnibus Incentive Plan and obtain a special resolution granting additional capacity to issue equity securities up to 10% of issued capital over a 12-month period under ASX Listing Rule 7.1A. The company also seeks approval for director Bruce Goodwin's election and advisory adoption of the Remuneration Report. If approved, the company could raise funds for drug manufacturing, clinical trials, and general working capital by issuing shares at no less than 75% of the volume-weighted average price. Radiopharm Theranostics Limited operates in the radiopharmaceutical theranostics sector.
Radiopharm Theranostics received a positive recommendation from its Data Safety and Monitoring Committee to advance its Phase 1 HEAT clinical trial for the radiotherapeutic asset 177Lu-RAD202 to Cohort 4. This move increases the dose level to 180mCi in patients with HER2-positive advanced solid tumors, following a previous announcement of the 130mCi dose level on April 8, 2026. The company highlighted a favorable safety profile observed to date and cited clinical proof-of-concept from a prior diagnostic study involving ten HER2-positive breast cancer patients that demonstrated positive safety and biodistribution. Radiopharm Theranostics operates in the biopharmaceutical industry, developing innovative oncology radiopharmaceuticals for diagnostic and therapeutic applications.
Radiopharm Theranostics announced it has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for October 1, 2026, to align on the design of a pivotal Phase 3 trial for RAD101 in patients with suspected recurrent brain metastases following radiotherapy. The company highlighted that its Phase 2b trial demonstrated 93% concordance between PET imaging using RAD101 and MRI across all evaluable lesions, meeting the primary endpoint. Radiopharm aims to be Phase 3-ready by year-end 2026, supported by a partnership with Siemens Healthineers for manufacturing and distribution in the U.S. The company operates in the clinical-stage biopharmaceutical industry, developing innovative oncology radiopharmaceuticals for diagnostic and therapeutic applications.