Bioline RX Ltd (NASDAQ:BLRX) shares jumped at the market open on Monday after the US Food and Drug Administration approved the use of Aphexda (motixafortide) in combination with filgrastim for patients with multiple myeloma, a type of bone marrow cancer.
The company’s Nasdaq-listed shares rose as much as 23% in pre-market trading before opening 10% higher at $2.33.
Multiple myeloma is the second most common hematologic malignancy, the Israel-based commercial-stage biopharmaceutical company explained in a statement.
With Aphexda administered by injection for subcutaneous use, it said the combination therapy is aimed at mobilizing hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
The FDA approval of the drug is based on results from the two-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled 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.
"Given the strong efficacy data shown in the GENESIS trial, which included patients who are representative of the current multiple myeloma patient population, we believe Aphexda will play a critical role in addressing unmet needs and introduce a new treatment paradigm for this challenging cancer," commented BioLineRx CEO Philip Serlin.
“The company is working relentlessly to make this important innovation in stem cell mobilization available to appropriate patients, their physicians and transplant teams."
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