BioLineRx Stock (BLRX): Why The Price Went Up Today

By Amit Chowdhry ● Jan 18, 2022
  • The stock price of BioLineRx Ltd (NASDAQ: BLRX) increased by over 5% during intraday trading today. This is why it happened.

The stock price of BioLineRx Ltd (NASDAQ: BLRX) – a late clinical-stage biopharmaceutical company focused on oncology – increased by over 5% during intraday trading today. Investors are responding positively to BioLineRx announcing that the company has completed a successful pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) regarding Motixafortide as a novel stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients.

The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA. And in particular to confirm that the company’s single Phase 3 pivotal study GENESIS is sufficient to support an NDA submission. During the pre-NDA meeting, the FDA had agreed that the proposed data package is sufficient to support an NDA submission, which the Company continues to anticipate will occur in H1 2022.

In May 2021, BioLineRx had announced positive top-line results from its GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients. This study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). Importantly, ~90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session.

KEY QUOTE:

“We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year. This successful meeting continues the positive momentum generated from the compelling results of our GENESIS Phase 3 study, which demonstrate a highly significant improvement over the current standard of care, alongside the positive results of the pharmacoeconomic study that we reported more recently. As a result, Motixafortide, if approved, has the potential to become the standard-of-care mobilization therapy for all multiple myeloma patients undergoing autologous stem cell transplantation, especially in light of new and more intense induction treatment regimens given to these patients, which make stem-cell mobilization more difficult than ever before.”

— Philip Serlin, Chief Executive Officer of BioLineRx

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.