01/08/2026
announces the completion of a Type B meeting with the U.S. Food and Drug Administration on next steps on pivotal strategy for (LM). The meeting resulted in constructive discussion with the regarding key elements of the potential pivotal study design for REYOBIQ in LM.
intends to incorporate this 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.
Full press release here: bit.ly/4qc4WBL
More about REYOBIQ™: plustherapeutics.com/reyobiq