BioLineRx (NASDAQ: BLRX) is having an incredibly strong start to the trading session this mroning, and for good reason. The comapny announced an FDA approval, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The approval;
- what we’re seeing from BLRX stock as a result; and
- what we’ll be watching for ahead.
BLRX Announces FDA Approval
As mentioned above, BioLineRx is having a great start to the trading session this morning after announcing an FDA approval. The announcement came by way of press release early this morning.
In the release, BLRX said that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AGI-134. AG-134 is a novel immunotherapy anti-cancer vaccine for solid tumors.
In a statement, Philip Serlin, CEO at BLRX, had the following to offer:
We are pleased with the FDA’s IND approval, which will enable us to expand our ongoing Phase 1/2a study, currently being carried out in the UK and Israel, to the US by the first half of 2020.
Pre-clinical studies have demonstrated that treatment with AGI-134 leads to complete regression of primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Furthermore, preclinical studies have also shown that, in addition to the monotherapy effect, the combination of AGI-134 with an anti-PD-1 immune checkpoint inhibitor demonstrates a synergistic effect in protection from secondary tumor growth. We look forward to the initial safety results of the trial in the second half of this year and anticipate initial efficacy results by the end of 2020.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to BioLineRx, the news proved to be overwhelmingly positive.
After all, the FDA approval of the IND means that the company will soon be moving into clinical trials with the asset. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:08), BLRX is trading at $0.44 per share after a gain of $0.053 per share or 13.85% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on BLRX. In particular, we’re interested in following the story surrounding the company’s continued work to develop its pipeline and expand value for investors. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!
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