BioLineRx Plans Pre-NDA Meeting For Motixafortide Plus G-CSF - Quick Facts

(RTTNews) - BioLineRx Ltd. (BLRX) said Zachary Crees from the Washington University School of Medicine in St. Louis delivered an oral presentation at American Society of Hematology on the successful results of the company's GENESIS phase 3 pivotal trial which assessed Motixafortide plus G-CSF for the mobilization of stem cells in multiple myeloma patients. Crees noted that 92.5% of patients in the Motixafortide+G-CSF arm achieved the primary endpoint, versus 26.2% for the placebo+G-CSF arm.

The company plans a pre-NDA meeting with FDA in the coming days. NDA submission is anticipated in first half, 2022.