Radiopharm completes U.S. Phase 2b enrolment for RAD 101 brain metastasis imaging trial

An announcement from Radiopharm Theranostics Limited ( (AU:RAD) ) is now available.

Radiopharm Theranostics has completed enrolment in its U.S. Phase 2b imaging trial of RAD 101, a novel FASN-targeting radiopharmaceutical being evaluated for diagnosing recurrent brain metastases across a range of solid tumours. Interim data show 18F-RAD101 achieved 90% concordance with gadolinium-enhanced MRI, and the study’s primary endpoint readout is expected in June 2026.

The company plans to move RAD 101 into a U.S. Phase 3 pivotal trial and engage with the FDA on the regulatory pathway, supported by the asset’s Fast Track designation for distinguishing recurrent disease from treatment effects. If validated, RAD 101 could address limitations of conventional MRI in intracranial metastatic disease, potentially improving clinical decision-making in a growing patient population of more than 300,000 annual U.S. cases of cerebral metastases.

The most recent analyst rating on (AU:RAD) stock is a Buy with a A$0.06 price target. To see the full list of analyst forecasts on Radiopharm Theranostics Limited stock, see the AU:RAD Stock Forecast page.

More about Radiopharm Theranostics Limited

Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing radiopharmaceutical products for both diagnostic and therapeutic use in oncology. Listed on the ASX and NASDAQ, it is building a diversified pipeline of peptides, small molecules and monoclonal antibodies targeting solid tumours such as lung, breast and brain metastases, with one Phase 2 and multiple Phase 1 trials underway in areas of high unmet medical need.

Average Trading Volume: 3,605,506

Technical Sentiment Signal: Sell

Current Market Cap: A$70.88M

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