Anavex Life Sciences Corp (NASDAQ: AVXL) is having an incredible start to the trading session in the pre-market hours this morning, and for good reason. The company announced that it has received IND approval from the FDA to move forward with a clinical trial. Of course, the news led to excitement among investors who are pushing the stock on a run for the top. Today, we’ll talk about:
- The IND approval news;
- what we’re seeing from AVXL stock as a result; and
- what we’ll be watching for ahead.
AVXL Announces IND Approval
As mentioned above, Anavex Life Sciences is having an incredibly strong start to the trading session this morning after the company announced that it has received IND approval. In a press release issued early this morning, the company said that it has received confirmation from the United States Food and Drug Administration that its Investigational New Drug application has been approved. Therefore, AVXL can now move forward with a Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome. Rett syndrome is a rare and catastrophic neurodevelopmental disease. Previously ANAVEX®2-73 received orphan drug designation from the FDA for the treatment of Rett syndrome.
In a statement, Christopher U Missling, PhD, President and CEO at AVXL, had the following to offer:
The acceptance of this IND by the FDA is a significant milestone for ANAVEX®2-73… This is an important step toward achieving clinical data for the third indication for ANAVEX®2-73 also incorporating genomic precision medicine biomarkers.
What We’re Seeing From the Stock
As investors, one of the first lessons that really sticks with us is that the news moves the market. When it comes to Anavex Life Sciences, the news proved to be great. After all, the company now has received regulatory approval to continue the development of ANAVEX®2-73, marking a major milestone for the investigational treatment. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:34), AVXL is trading at $2.95 per share after a gain of $0.48 per share or 19.43% 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 AVXL. In particular, we’re interested in following the story surrounding the ongoing development of ANAVEX®2-73 as recent data and news surrounding the treatment seem to be positive. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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