Atossa Genetics (ATOS) Climbs On FDA Acceptance

Atossa Genetics Inc (NASDAQ: ATOS)

Atossa Genetics is having a great day in the market today after receiving word from the United States Food and Drug Administration with regard to their breast cancer candidate, Fulvestrant. Today, we’ll talk about what this means for the company, how the market reacted to the news, and what we can expect to see from ATOS moving forward. So, let’s get right to it…

FDA Accepts Human Trials For Fulvestrant

Fulvestrant is an investigational drug designed for the treatment of women with Ductal Carcinoma in Situ (DCIS), also known as breast cancer. Recently, Atossa Genetics submitted an Investigational New Drug Application with the FDA for a clinical trail for the testing of the breast cancer treatment candidate. Today, the company announced that the FDA has accepted the application which means that Atossa has the ability to proceed with an open-label, non-randomized pharmacokinetic and safety study of Fulvestrant in women with DCIS. During the announcement, Dr. Steven Quay, ATOS CEO had the following to say…

The FDA’s acceptance of our Fulvestrant IND is a significant milestone for Atossa that hallmarks a potentially new, locally administered treatment for DCIS via intraductal administration utilizing our patented microcatheters… DCIS is a serious medical condition diagnosed in approximately 60,000 women a year in the U.S. The current standard of care for these women includes surgical reemoval of the tumor, radiation, and/or Tamoxifen treatment and in some cases mastectomy. Together with our Afimoxifene Gel, we now have two Phase II programs underway,”

How The Market Reacted To The News

As we’ve come to expect anytime a biotechnology company releases positive news they’ve received from the FDA, we can expect positive news from the company’s stock and that’s exactly what we’re seeing. Currently (12:45), ATOS is trading at $0.93 per share after a gain of 13.40% so far today.

What We Can Expect To See Moving Forward

Moving forward, I’m expecting to see a continuation of positive news. In the short term, we are likely to see slow and steady growth as the Phase II trials continue. However, based on what I’ve seen from ATOS and Fulvestrant, I would imagine that the results of the studies will be positive which will likely act as a catalyst that pushes the stock even higher. Overall, ATOS investors have plenty of reason to be excited!

What Do You Think?

Where do you think ATOS is headed and why? Let us know in the comments below!

[Image Courtesy of Puget Sound Business Journal]


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