BioLineRx (BLRX) Stock Rockets on Phase 3 Clinical Data

BioLineRx BLRX Stock News

BioLineRx ADR (NASDAQ: BLRX) is making a run for the top in the market this morning, and for good reason. The company announced positive interim data from a Phase 3 clinical trial. Here’s what’s going on:

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BLRX Stock Heads Up on Phase 3 Data

In the press release, BioLineRx announced positive data from the GENESIS Phase 3 clinical trial. In the trial, the company is assessing its motixafortide for stem cell mobilization (SCM) treatment as a potential option for patients with multiple myeloma.

According to the press release, the independent Data Monitoring Committee, or DMC, has reviewed the data, concluding that the company may stop enrollment immediately as there is clear and statistically significant evidence favoring the treatment.

As a result, BLRX said that study enrollment is now complete at 122 patients. Full results for the study, including secondary endpoints and extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation. This is expected to take place in the first half of 2021.

In a statement, Philip Serlin, CEO at BLRX, had the following to offer:

The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company’s most efficient path to registration for motixafortide. Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication.

The Bottom Line

The news released by BioLineRx this morning proved to be overwhelmingly positive. Let’s not forget, the trial is a Phase 3, pivotal clinical trial. That means that if all goes well in the trial, the company will make a move toward potentail FDA approval by submitting a New Drug Application.

All signs point to that taking place.

With the DMC seeing such statistically significant evidence of the trial meeting its primary endpoint that it advised BLRX to end enrollment in the trial early, investors have reason to be excited here. Based on today’s announcement, it would be utterly shocking to find out that the trial missed expectations next year.

With that said, this is a huge opportunity. My 2026, the multiple myeloma market is expected to grow to be worth more than $30 billion per year. While BLRX isn’t likely to take 100% of the market, it doesn’t have to. With such a vast market, a small fraction of the share would be meainingful for the company.

Nonetheless, should positive data continue, the drug cold quickly become a blockbuster on commercialization. All in all, BLRX stock is one to pay close attention to.

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