Atossa (ATOS) Stock Up, FDA Accepts Fulvestrant Investigational Drug Application

NEW YORK (TheStreet) -- Shares of Atossa Genetics  (ATOS) shares are up 21.95% to $1 in early market trading on Monday after the company announced that the U.S. Food and Drug Administration accepted its Investigational New Drug Application for a clinical trial on its breast cancer treatment candidate.

The FDA's accpetance of the application means that Atossa can proceed with open-label, non-randomized pharmacokinetic and safety study of Fulvestrant in women with Ductal Carcinoma in Situ (DCIS) or breast cancer.

"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," said CEO Dr. Steven Quay.

"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 removal 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," said Dr. Quay.

TheStreet Ratings team rates ATOSSA GENETICS INC as a Sell with a ratings score of D. TheStreet Ratings Team has this to say about their recommendation:

"We rate ATOSSA GENETICS INC (ATOS) a SELL. This is driven by multiple weaknesses, which we believe should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks we cover. The company's weaknesses can be seen in multiple areas, such as its disappointing return on equity, weak operating cash flow, poor profit margins and generally disappointing historical performance in the stock itself. "

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