The company is targeting around 200 centers that treat the vast majority of the few thousand pediatric low-grade glioma patients who are candidates for the RAF-targeting drug.

Glioblastoma carries a grim prognosis. The biopharma industry is trying to improve patient outcomes, with 120 drugs in the pipeline and two anticipated approvals this year.

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

The South Korean biotech space has been marked by multiple positive R&D developments and pipeline and partnering progress in recent months, more than outweighing some other setbacks for the rapidly developing sector.