Aethlon Medical, Inc. (NASDAQ: AEMD) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that it has received “Breakthrough Device” designation from the FDA with regard to its Aethlon Hemopurifier. Of course, the news excited investors who are sending the stock on a run for the top. Today, we’ll talk about:
- The FDA news;
- what we’re seeing from the stock; and
- what we’ll be watching for with regard to AEMD ahead.
AEMD Announces Breakthrough Device Designation
As mentioned above, Aethlon Medical is having an incredibly strong start to the trading session today after announcing that it has received Breakthrough Device designation from the FDA. The designation was provided to support the advancement of its Hemopurifier for the treatment of cancer. The device was designed for the rapid depletion of cancer-promoting exosomes and life-threatening viruses.
The Breakthrough Device program facilitates more rapid patient access to devices that receive this designation. This is incredibly positive news for AEMD as it will shorten the path toward commercialization and provide the company with further support from the FDA throughout the development process.
The potential here is incredible. After all, Cancer is the second leading cause of death globally. At the moment, tumor-derived exosomes are not addressed by any approved therapy and have been shown to promote immune supression, seed the spread of metastasis and inhibit the benefit of many leading therapies. Therefore, should all go well with this product, AEMD may be on the verge of a significant breakthrough in the tretment of cancer, in terms of both lives saved and revenue earned.
In a statement, Jim Joyce, founder and CEO at AEMD, had the following to offer:
We are honored to receive this breakthrough designation in oncology as it establishes an opportunity to expand the market for our Hemopurifier and advance our vision for addressing a significant unmet need in cancer care… By reducing the presence of tumor-derived exosomes from the circulatory system of cancer patients, we believe our Hemopurifier can improve the benefit of existing cancer treatment regimens and emerging immuno-oncology drugs. Thus providing a rationale for potential partnering opportunities.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of Aethlon Medical, the news proved to be overwhelmingly positive. After all, breakthrough device designation will likely shorten the path to approval while providing additional support from the FDA. So, it’s not surprising to see that excited investors are sending the stock on a run for the top this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:55), AEMD is trading at $1.48 per share after a gain of $0.31 per share or 26.50% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on AEMD. In particular, we’re interested in following the continued development of the Aethlon Hemopurifier as the Breakthrough Device designation will shorten the period from here to potential approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!