BioLineRx Announces Submission Of Its First NDA - Quick Facts

(RTTNews) - BioLineRx Ltd. (BLRX) has submitted New Drug Application to the FDA for Motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients. The company noted that the submission was based on overwhelmingly positive top-line results from GENESIS phase 3 study.

The FDA's decision on acceptance of the company's NDA filing is expected in November. The company said the potential PDUFA date would be in the second quarter of 2023 or third quarter of 2023.

BioLineRx is a pre-commercial-stage biopharmaceutical company focused on oncology. The company's lead program, Motixafortide, is a cancer therapy platform.

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