BLRX - BioLineRx files for FDA approval of motixafortide in stem cell mobilization

• BioLineRx ( NASDAQ: BLRX ) submitted its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Motixafortide in stem cell mobilization (SCM) for autologous bone marrow transplantation for patients with multiple myeloma.
• The NDA was backed by data from a phase 3 trial called GENESIS, which had met all main and secondary goals, the company said in a Sept. 12 press release.
• BioLineRx expects a decision on the NDA acceptance by the FDA in November.
• BLRX -4.40% to $1.74 premarket Sept. 12.

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