SillaJen is showing a rapid rise in the early trading hours on the 22nd. This is due to reports that it has received approval from the U.S. Food and Drug Administration (FDA) for changes to its clinical trial plan (IND) for an anticancer drug.
As of 9:16 a.m. on that day, SillaJen is being traded at 3,000 won, an increase of 560 won (22.95%) compared to the previous trading day.
SillaJen announced that it received approval from the U.S. Food and Drug Administration (FDA) for changes to the IND of the anticancer drug "BAL0891" just before the market closed the previous day. The clinical trial of BAL0891 will be expanded to patients with acute myeloid leukemia (AML).
SillaJen is conducting initial clinical trials targeting patients with relapsed and refractory conditions. The plan is to confirm whether the anticancer drug is safe and effective. According to SillaJen, recent preclinical studies using an acute myeloid leukemia transplantation model showed that BAL0891 suppresses tumor growth and increases survival chances.
SillaJen also announced that it has decided to acquire the material patent and biomarker patent rights for BAL0891 from the Dutch biotech company Crossfire Oncology Holdings. This contract is expected to significantly reduce milestone expenses.