BLRX - BioLineRx gets FDA review of stem cell therapy Aphexda for blood cancer patients
- The U.S. Food and Drug Administration (FDA) accepted for review BioLineRx's ( NASDAQ: BLRX ) application seeking approval of Aphexda (motixafortide) in stem cell mobilization (SCM) for autologous transplantation in patients with multiple myeloma.
- The FDA is expected to make a decision on the new drug application (NDA) by Sept. 9, 2023.
- The NDA, which was submitted in September, was backed by data from a phase 3 trial called GENESIS, the Israeli company said in a press release on Thursday.
- "The clinical outcomes demonstrated by our GENESIS Phase 3 study showed that nearly 90 percent of patients collected an optimal number of cells for transplantation following a single administration of APHEXDA and in only one apheresis session. We believe APHEXDA can become the standard of care in the multiple myeloma transplant setting," said BioLineRx CEO Philip Serlin.
- BLRX +3.10% to $0.81 premarket Nov. 10
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BioLineRx gets FDA review of stem cell therapy Aphexda for blood cancer patients