November 24, 2025 — HOUSTON — Leads & Copy — Plus Therapeutics, Inc., a healthcare company focused on precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, has concluded a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss clinical development plans for REYOBIQ in treating leptomeningeal metastases (LM).
The meeting, which occurred on November 7th, involved discussions regarding the design of a planned pivotal or registrational trial for REYOBIQ.
Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics, noted the meeting as “very constructive,” and said it builds upon previous positive interactions with the FDA regarding the clinical development and manufacturing of Reyobiq for CNS cancers. The company anticipates providing an update and guidance on its next steps early in 2026, following the receipt of the official minutes from the FDA meeting.
Plus Therapeutics plans to implement specific changes to its LM trial to align with FDA recommendations, which the company expects will help to advance the clinical development timeline.
Leptomeningeal metastases (LM) is a complication of advanced cancer that affects the fluid-lined structures of the central nervous system, and occurs in approximately 5% of patients with metastatic cancer. The most common sources of LM include breast cancer, lung cancer, and melanoma. Patients with LM typically have a median survival rate of only 2-6 months, and treatment options are limited.
REYOBIQ (rhenium Re186 obisbemeda) is an injectable radiotherapy designed to deliver targeted high-dose radiation directly to CNS tumors. It has the potential to reduce off-target risks and improve outcomes for CNS cancer patients by delivering a more targeted and potent radiation dose, compared to currently approved therapies. Rhenium-186 has a short half-life and emits both beta and gamma energy, which is suited for CNS therapeutic applications. The ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials are currently evaluating REYOBIQ for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer.
The ReSPECT-GBM trial is supported by an award from the National Cancer Institute (NCI), a division of the U.S. National Institutes of Health (NIH). The ReSPECT-LM trial is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, Inc., develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas and is focused on developing targeted radiotherapeutics for cancers of the central nervous system. The company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) by combining image-guided local beta radiation and targeted drug delivery approaches.
Investor Contact:
CORE IR
investor@plustherapeutics.com
Source: Plus Therapeutics, Inc.
