Radiopharm Theranostics announced a clinical supply agreement with Siemens Healthineers to radiolabel and distribute its investigational PET tracer RAD101 in the United States. The agreement secures 18F‑labeled product for the company’s upcoming Phase 3 registrational trial, which targets fatty acid synthase in brain metastases.
The partnership gives Radiopharm access to Siemens’ U.S. radiopharmacy network and manufacturing capabilities, mitigating the short‑lived isotope supply risk that has historically constrained multi‑center trials. By ensuring a reliable supply chain, Radiopharm can aim to launch the Phase 3 study by the end of 2026, a milestone that could unlock FDA Fast Track status and accelerate commercialization.
Radiopharm’s interim Phase 2b data showed 90% concordance between RAD101 PET imaging and MRI, meeting the primary endpoint and supporting the progression to Phase 3. The company’s Fast Track designation underscores the unmet need for improved diagnostic precision in brain metastases, a market of over 300,000 patients annually in the U.S.
CEO Riccardo Canevari said, "This partnership marks a milestone for Radiopharm, as we bring RAD101 closer to improving diagnostic precision for brain metastases." He added, "This partnership ensures our supply of 18F‑labeled RAD101 in the U.S. for the initiation of the multi‑center global Phase 3 registrational trial following our readout of topline data in the Phase 2b trial in the first half of 2026."
Barry Scott, Head of Radiopharma at Siemens Healthineers, noted, "As the leader in PET imaging solutions, we are pleased to partner with Radiopharm Theranostics to provide our reliable and specialized manufacturing capabilities."
The agreement also positions Radiopharm as an attractive partner for future collaborations or acquisitions, given its strong pipeline and the strategic value of a reliable U.S. supply chain. The company’s market capitalization stands at $51.6 million, with a current ratio of 3.01 and cash of A$59 million, sufficient to fund operations through 2027 despite persistent losses and cash burn.
Siemens Healthineers’ extensive PETNET Solutions network and its recent acquisition of Advanced Accelerator Applications (AAA) from Novartis further enhance its capacity to distribute short‑lived isotopes, reinforcing the robustness of the supply arrangement.
Overall, the supply agreement removes a critical operational hurdle, strengthens Radiopharm’s Phase 3 timeline, and reinforces its position in the competitive radiopharmaceutical landscape.
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