Plus Therapeutics reported that it completed a Type B meeting with the U.S. Food and Drug Administration on January 8, 2026 to discuss the pivotal trial strategy for its radiopharmaceutical REYOBIQ in leptomeningeal metastases (LM). The FDA’s feedback focused on the design of the current dose‑optimization study and, most notably, on the choice of clinical endpoints for the future pivotal trial.
The agency indicated that data were insufficient to support circulating tumor cells (CTCs) as an intermediate clinical endpoint and recommended overall survival as the primary endpoint. This shift to a hard‑end survival measure is expected to lengthen the pivotal trial and increase the resources required for the study, potentially delaying the drug’s regulatory approval and market entry.
In response, Plus Therapeutics said it will incorporate the FDA’s comments into the protocol and plan a revised protocol later in the year. The company also confirmed that it will accelerate commercial manufacturing and scale‑up activities to be ready for a potential pivotal trial once the dose‑optimization study concludes.
Financially, the company’s most recent quarterly report for Q3 2025 showed a net loss and revenues that missed estimates, underscoring a cash‑burn profile that has drawn analyst attention. The regulatory milestone is therefore viewed as a critical step toward a future approval that could improve the company’s long‑term financial outlook.
Following the announcement, Plus Therapeutics’ stock fell 3.5% on the day of the meeting, a reaction that analysts linked to the FDA’s recommendation for overall survival as a primary endpoint. Investors interpreted the change as a signal of a longer and more complex development pathway for REYOBIQ.
Dr. Marc H. Hedrick, President and Chief Executive Officer, said the meeting was “constructive” and that the company would use the FDA’s guidance to speed up clinical development timelines and facilitate a faster submission for REYOBIQ in LM. He added that the company would also accelerate manufacturing and scale‑up activities to support a future pivotal trial.
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