BioLineRx Seeks FDA Nod For Stem Cell Mobilization Candidate

BioLineRx BLRX has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate Motixafortide in stem cell mobilization (SCM) for autologous bone marrow transplantation for multiple myeloma patients.

The regulatory submission is based on the positive top-line results from GENESIS Phase 3 trial of Motixafortide on top of G-CSF in stem cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.

The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001) and combination was also found to be safe and well tolerated.

Philip Serlin, Chief Executive Officer, commented: "The submission of our first NDA is a significant milestone for our Company and gives us potential line of sight towards launching a product that we successfully developed for an indication in substantial need of more effective treatment options. Notably, ~90 percent of multiple myeloma patients in the GENESIS study went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session, compared to less than 10 percent of those receiving G-CSF alone.”

The company anticipates the regulatory decision on acceptance of NDA filing in November. If the filing is accepted, the potential PDUFA date would be in the second quarter of 2023 or in the third quarter of 2023.

Price Action : BioLineRx shares traded around 8 percent down at $1.65 on Monday.