BioLineRx ADR (NASDAQ: BLRX) is screaming for the top in the market this morning, and for good reason. The company announced positive top-line results from a Phase 3 clinical trial, setting the stage for an application to the FDA relatively soon. Here’s what’s going on:
BLRX Stock Climbs On Positive Data
In the press release, BioLineRx announced positive topline results from its GENESIS Phase 3 clinical trial. The trial was designed to assess the company’s lead candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.
In the release, the company said that the data analysis included data from all 122 enrolled patients and found highly statistically significant evidence across all primary and secondary endpoints, that Motixafortide in combination with G-CSF, performs better than placebo plus G-CSF.
The primary endpoint of the study produced a 4.9-fold increase in the proportion of patients in the treatment arm after only one administration of the treatment. The study also achieved its main secondary endpoint, demonstrating a 14.1-fold increase in the patients in the treatment arm.
Along with the positive efficacy results, came a strong tolerability and safety profile.
In a statement, John DiPersio, MD from the Washington University School of Medicine, lead investigator on the trial, had the following to offer:
The results of the GENESIS study are extremely impressive, and all the more so when considering that almost 90% of the patients in the treatment arm proceeded to transplantation after only one apheresis session. This is a great achievement in alleviating the burden for the patients and reducing hospital resources. I believe these results make the combination of Motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation.
The above statement was followed up by Philip Serlin, CEO at BLRX. Here’s what he had to say:
These strikingly positive data significantly exceeded our expectations, and are truly transformational for our company. The statistical significance across all primary and secondary endpoints was consistent across twelve different sensitivity analyses. These results support our goal of becoming the standard of care for autologous bone-marrow transplantation, providing a strong clinical and pharmaco-economic advantage for its use, on top of G-CSF, in all transplant procedures.
We are working aggressively to gain regulatory approval for Motixafortide in this transplant setting for multiple myeloma patients – with plans to make an NDA submission in the first half of next year – and we are also pressing forward to unlock the full potential of this therapy in this and other stem-cell mobilization indications. I would like to express our sincere thanks to the patients and investigators who participated in the study and enabled its great success.
The Bottom Line
This news is massive. With the positive data released, the company has everything it needs to move forward with a New Drug Application to the FDA for approval of the treatment. Considering the overwhelmingly positive data, there’s a strong chance that application will be approved.
Should the drug be approved, BioLineRx will be tapping into an industry worth nearly $20 billion a year, generating a significant opportunity on the path toward profitability. All-told, BLRX stock is one to watch closely.