BioLineRx, a biopharmaceutical company, saw its shares surge by 22% to $2.54 in premarket trading following the approval of Aphexda motixafortide by the U.S. Food and Drug Administration (FDA). This approval allows the use of Aphexda in combination with filgrastim to mobilize hematopoietic stem cells in patients with multiple myeloma, enabling their collection and subsequent autologous transplantation.
New 52-Week High Potential
If the stock maintains its current price, it will set a new 52-week high, surpassing the previous peak of $2.53 reached just last Tuesday. Share prices had already increased by 15% at Friday’s close, indicating positive market sentiment.
Innovative Stem Cell Mobilization
Aphexda represents a significant breakthrough in stem cell mobilization for multiple myeloma, becoming the first innovation in this field to receive FDA approval in the past ten years. This development is a major milestone for BioLineRx and provides new hope for patients with this condition.
Promising Results from Phase 3 Trial
The FDA approval of Aphexda is based on the results of a Phase 3 trial, which consisted of a randomized, double-blind study evaluating the safety and efficacy of Aphexda plus filgrastim compared to placebo plus filgrastim. These findings demonstrated the successful mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients.
BioLineRx plans to make Aphexda available to patients later this month, bringing this groundbreaking treatment option within reach for those who need it.