Atossa Genetics Inc (NASDAQ: ATOS) is flying early on in the trading session this morning, and for good reason. The company announced that it has received an FDA approval, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from ATOS stock as a result; and
- what we’ll be watching for ahead.
ATOS Rockets On FDA Approval
As mentioned above, Atossa Genetics is having a great start to the trading session this morning after announcing an FDA approval. The announcement came by way of press release in the pre-market hours.
In the release, ATOS said that the FDA has issued a “Safe to Proceed” letter under their “expanded access” program. The letter permits the use of oral Endoxifen as a most-mastectomy treatment in a pre-menopausal, estrogen-recepter positive breast cancer patient.
In the release, the company said that the patient has completed a 3-week course of its oral Endoxifen prior to her surgery under the FDA-approved program.
The comapny said that the tumor activity from the initial biopsy was compared to the tumor at surgery. This comparison showed that cancer cell biological activity was reduced with KI-67 being reduced by around 50% and the estrogen receptor content being reduced by more than 20%.
Also, there were no safety or tolerability concerns observed in the patient. In a statement, Dr. Steven C. Quay, President and CEO at ATOS, had the following to offer:
We are extremely pleased that this patient not only benefitted from Endoxifen prior to her surgery, but that the FDA agrees that continued Endoxifen therapy is appropriate for this pre-menopausal patient.
This positive progress supports our expansion of oral Endoxifen clinical trials. After surgery is completed, the current standard of care in the USA to prevent a recurrence and/or a new cancer is for patients to undergo ovarian ablation (chemical treatment to induce menopause) and take aromatase inhibitors (AI) for 5 to 10 years. Alternatively, tamoxifen therapy can be used for 5-10 years for those patients who do not want to take AIs, or for whom these medications are contraindicated. This patient, like many others, was not a good candidate for tamoxifen therapy due to low liver enzyme (CYP2D6) activity which means her liver would not adequately metabolize tamoxifen. Unlike tamoxifen, oral Endoxifen does not require liver metabolism so it may be a better treatment approach.
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 Atossa Genetics, the news proved to be overwhelmingly positive.
After all, the strong data from this real-world patient will help to push the company into commercialization with a full approval from the FDA. So, it’s not surprising to see that excited investors are sending the stock screaming 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 (9:55), ATOS is trading at $5.03 per share after a gain of $3.48 per share or 230.46% 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 patients in need. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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