Plus announces completion of Type B meeting with U.S. FDA for REYOBIQ

Plus Therapeutics (PSTV) announces the completion of a Type B meeting with the U.S. Food and Drug Administration on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases. The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company’s goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM.