Atossa Genetics Inc (NASDAQ: ATOS) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced an FDA approval, exciting investors and sending the stock screaming for the top. Today, we’ll talk about:
- The approval;
- what we’re seeing from ATOS stock as a result; and
- what we’ll be watching for ahead.
ATOS Announces FDA Approval
As mentioned above, Atossa Genetics is having an incredibly strong start to the trading session in the pre-market hours this morning after announcing an FDA approval. In a press release issued early this morning, the company said that the FDA has approved an “expanded access” of its oral Endoxifen. The approval is for the treatment in a preoperative setting for a U.S. patient awaiting surgery for breast cancer. It is worth mentioning that ATOS said that under the expanded access approval, oral Endoxifen’s use is restricted to this patient only.
In a statement, Steven C. Quay, Ph.D., MD, President and CEO at ATOS, had the following to offer:
A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic therapy is typically an aromatase inhibitor and a drug for ovarian suppression. The patient’s physician was reluctant to use this preoperative therapy as it typically induces menopause and can have other potentially serious side effects. We worked with the physician to apply to the FDA to provide “expanded access” (formerly known as compassionate use) to this patient under an Investigational New Drug (IND) application. We are very pleased to report that the FDA approved this single-patient study, and the patient is currently receiving our proprietary oral Endoxifen preoperatively.
This is the same clinical setting as our Phase 2 ‘window of opportunity’ study of preoperative systemic oral Endoxifen in breast cancer patients which is open for enrollment in Australia.
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. In the case of ATOS, the news proved to be overwhelmingly positive. After all, the FDA approval means that the company will be able to provide this patient with Endoxifen, ultimately leading to what will become a real-world case study and pushing the stock further down the development path. So, it’s not surprising to see that excited investors are pushing the stock toward the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:10), ATOS is trading at $1.61 per share after a gain of $0.47 per share or 41.23% 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 ATOS. In particular, we’re interested in following the story surrounding the development of Endoxifen as today’s news pushes the development of the drug further down the path. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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