BioLineRx Shares Climb 22% After FDA Approves Aphexda With Filgrastim

By Chris Wack

BioLineRx shares advanced 22% to $2.54 in premarket trading after the U.S. Food and Drug Administration approved Aphexda motixafortide in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

If the stock stays at this price, it will be a new 52-week high, surpassing the $2.53 it hit last Tuesday. Shares were up 15% at Friday's close.

The biopharmaceutical company said Aphexda is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade.

Aphexda, the company's first approved therapeutic, is administered by injection, for subcutaneous use.

The FDA approval of Aphexda is based on results from a 2-part, Phase 3 trial, a randomized, double-blind study evaluating the safety and efficacy of Aphexda plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.

BioLineRx expects to make Aphexda available later this month.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 11, 2023 08:05 ET (12:05 GMT)

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