BioLineRx Gets FDA Approval for Aphexda With Filgrastim

By Chris Wack

BioLineRx said Monday that the Food and Drug Administration has approved Aphexda motixafortide in combination with filgrastim to mobilize stem cells to treat patients with multiple myeloma.

The stock was halted at $2.18 in premarket trading.

BioLineRx expects to make Aphexda available later this month.

Aphexda mobilizes hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. The success of autologous stem cell transplantation depends on adequate mobilization of stem cells during the treatment process, the Israeli biopharmaceutical company said.

The FDA approval of Aphexda is based on results from a two-part, Phase 3 trial evaluating the safety and efficacy of Aphexda plus filgrastim, compared with placebo plus filgrastim.

Multiple myeloma is an incurable blood cancer that affects certain white blood cells and is the second most-common hematologic malignancy, BioLineRx said.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

09-11-23 0737ET