Radiopharm advances three programs across RAD202, RAD101, and BetaBart

Radiopharm Theranostics disclosed progress across three clinical programs in a series of August 2026 filings with the SEC.

On August 20, 2026, the company said it received a positive recommendation from its Data Safety and Monitoring Committee to advance 177Lu-RAD202 to the next dose level of 180mCi in the Phase 1 HEAT trial for patients with HER2-positive advanced solid tumors¹. That trial is being run at clinical centers across Australia¹, and the prior dose level of 130mCi was announced on April 8, 2026, according to the filing. RAD202 had already been tested in HER2-positive breast cancer patients: a previous diagnostic study involving ten such patients showed RAD202 achieving clinical proof-of-concept along with favorable safety and biodistribution results¹.

Separately, on August 17, 2026, Radiopharm announced it had scheduled an End-of-Phase 2 meeting with the FDA for October 1, 2026, to work out the design of a pivotal Phase 3 study of RAD101 in patients suspected of having recurrent brain metastases after radiotherapy². The company said the discussion would cover enrollment size and both primary and secondary endpoints², based on Phase 2b results showing 93% concordance between MRI and PET imaging in this patient population². Radiopharm also noted a manufacturing tie-up in which Siemens Healthineers will produce and distribute doses of 18F-labeled RAD101 to support the planned U.S. Phase 3 trial².

Finally, on August 26, 2026, Radiopharm reported dosing the first patient in the second cohort of its Phase 1/2a trial of RV-01 (177Lu-Betabart) at a 70 mCi dose, following a positive recommendation from the trial's Safety and Monitoring Committee³.