Atossa Genetics news about it getting approval from the U.S. Food and Drug Administration (FDA) for one its its drugs has its stock soaring.
Atossa Genetics (NASDAQ:ATOS) has announced that its breast cancer drug Endoxifen has been given special approval by the FDA. This approval is for using the drug to treat a specific patient under the organization’s expanded access program.
This Atossa Genetics news has the company using Endoxifen as a “post-mastectomy treatment in a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient.” This same patient also took part in a three-week course of the drug prior to her surgery.
Here’s what Dr. Steven C. Quay, President and CEO of Atossa Genetics, has to say about the news.
“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.”
ATO stock was up 249% as of noon Thursday.
As of this writing, William White did not hold a position in any of the aforementioned securities.