India, Aug. 17 -- Radiopharm Theranostics Ltd. (RADX), a clinical-stage biopharmaceutical company developing radiopharmaceuticals for oncology, announced that it has scheduled an End-of-Phase 2 meeting with the U.S. FDA to discuss the pivotal Phase 3 development of RAD101 for the diagnosis of recurrent brain metastases.
FDA Meeting & Phase 3 Plans
The company will meet with the FDA on October 1, 2026, to align on the design of a pivotal Phase 3 trial evaluating RAD101 in patients with suspected recurrent brain metastases following radiotherapy.
Discussions will focus on key Phase 3 design elements, including patient enrollment and primary and secondary endpoints.
Radiopharm expects to finalize its registrational strategy and be Phase 3-...