Plus Therapeutics completes FDA meeting on REYOBIQ development plans

Plus Therapeutics (PSTV) completed a Type B meeting with the U.S. Food and Drug Administration on November 7th to discuss its REYOBIQ clinical development plans for leptomeningeal metastases including the design of a planned pivotal or registrational trial. “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 Hedrick, CEO. “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.”