FDA Type B Meeting Supports Development Path For Plus Therapeutics’ Targeted Radiotherapy REYOBIQ In CNS Cancers

Plus Therapeutics, Inc., a developer of precision diagnostics and radiopharmaceuticals for central nervous system cancers, announced the successful completion of a Type B meeting with the U.S. FDA on November 7. The discussion focused on advancing the company’s REYOBIQ clinical program for leptomeningeal metastases (LM), including key elements of its upcoming pivotal or registrational trial design.

“Our recent FDA meeting was very constructive, building on multiple previous positive meetings with the FDA on the clinical development and manufacturing of Reyobiq for CNS cancers,” said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. “Following receipt of the FDA meeting minutes, the Company expects to provide an update and guidance on next steps early in 2026. We also will implement certain focused amendments to our LM trial that should help advance the overall clinical development timeline in alignment with the FDA recommendations.”

Leptomeningeal metastases represent a rare and aggressive complication of advanced cancers, affecting the fluid-filled membranes of the CNS. Although LM occurs in about 5% of metastatic cancer cases, most commonly originating from breast cancer, lung cancer, or melanoma, patients face extremely poor prognoses, with median survival ranging from two to six months. Limited available treatments underscore the critical need for innovative and effective therapeutic options.

Plus Therapeutics’ REYOBIQ (rhenium Re186 obisbemeda) is an advanced injectable radiotherapy engineered to deliver precise, high-dose targeted radiation to CNS tumors while minimizing off-target effects. The therapy uses rhenium-186, a radioisotope ideal for CNS applications due to its short half-life and dual beta-gamma emission profile, enabling both cancer cell destruction and real-time imaging. REYOBIQ is currently being studied across multiple indications—including recurrent glioblastoma, LM, and pediatric brain cancers—within the ReSPECT clinical trial series, supported by major funding from the NCI, CPRIT, and the U.S. Department of Defense.