Atossa Genetics Inc (NASDAQ: ATOS) is having a great start to the trading session this morning, and for good reason. The company announced positive results from the expanded access program surrounding a clinical-stage product. With the positive news in mind, excited investors are pushing the stock on a run for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from ATOS stock as a result; and
- what we’ll be watching for ahead.
ATOS Announces Positive Data
As mentioned above, Atossa Genetics is having a great start to the trading session this morning after announcing positive data. In a press release issued early this morning, the company updated the status of the pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient that received preoperative oral Endoxifen therapy.
The therapy was provided to the patient under an FDA-approved expanded-access program with a goal of reducing activity of cancer cells prior to surgery.
In the release, ATOS said that the patient received daily doses of its oral Endoxifen for about 3 weeks before surgery. During the program, the company saw no safety or tolerability issues and the surgery was completed successfully.
The test results from the initial biopsy were compared with those from the specimen obtained during surgery. This comparison was designed to determine if oral Endoxifen reduced the biological activity of cancer cells.
In the release, the company said that a reduction of the cancer cell biological activity was observed by a significant reduction in estrogen receptor content in the tumor.
In the release, the company said that following the diagnosis, the patient sought options to the current standard of care following surery. However, because she was not a candidate for tamoxifen therapy due to low liver enzyme activity and not wanting to go into menopause, her physician explored other treatment options.
This search ultimately led to oral Endoxifen and a request to the FDA for expanded access for a single patient in the window of opportunity setting. The FDA approved this request, leading to the opportunity to treat the patient.
In a statement, Dr. Steven C. Quay, President and CEO at ATOS, had the following to offer:
We are very encouraged by these results. There is a significant opportunity and need to reduce cancer cell activity prior to surgery. As such, we are currently conducting a Phase 2 study with our proprietary oral Endoxifen in this pre-operative, or ‘window of opportunity,’ setting 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. When it comes to Atossa Genetics, the news proved to be incredibly positive. After all, the company’s candidate was approved for expanded access use, leading to strong results that suggest efficacy and the lack of safety and tolerability issues. So, it’s not surprising that excited investors are pushing 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 (9:45), ATOS is trading at $1.72 per share after a gain of $0.23 per share or 15.68% 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 company’s continued work to bring oral Endoxifen to market, especially considering the positive data that was released today. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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