OPKO Health (NASDAQ:OPK) spotted trading -68.59% off 52-week high price. On the other end, the stock has been noted 16.18% away from the low price over the last 52-weeks. The stock changed -0.99% to recent value of $2.01. The stock transacted 8354584 shares during most recent day however it has an average volume of 4384.34K shares. The company has 621.74M of outstanding shares and 356.91M shares were floated in the market.
OPKO Health (NASDAQ:OPK) announces that the Company has submitted a de novo request to the U.S. Food and Drug Administration (FDA) seeking regulatory clearance for the 4Kscore® test. The 4Kscore® test is a blood test used by health care professionals to assess a patient’s risk of having aggressive prostate cancer after an abnormal prostate specific antigen (PSA) test result, and before a decision is made to perform a biopsy.
The de novo pathway for approval is available to medical devices of low-to-moderate risk that do not have an approved predicate device. Per FDA guidelines, the Company expects to receive a response to this request within approximately 180 days.
We are happy to report the submission of our regulatory filing to the FDA for the 4Kscore® test. In multiple prospective controlled clinical studies, the 4Kscore® test has shown consistent high sensitivity and high predictive values to identify men at higher risk of aggressive prostate cancer and who will benefit from a prostate biopsy, while helping to avoid biopsies in men who are at low risk, said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. We believe FDA clearance for the 4Kscore® test will help to maximize its market availability and reimbursement.
The four biomarkers included in the 4Kscore® test are the result of more than a decade of research by scientists in Europe and the U.S., including scientists from the University of Turku and Memorial Sloan Kettering Cancer Center. Through extensive research and multiple prospective controlled clinical validation studies, including large long-term outcome studies, the 4Kscore® test with its algorithm in place for the last several years, has been shown to stratify subjects into low- and high-risk groups for future prostate cancer metastasis and mortality. The 4Kscore® test has been included in the National Comprehensive Cancer Network Guidelines® (NCCN) and American Urological Association guidelines since 2015, and the European Association of Urology Prostate Cancer Guidelines since 2016. Its earnings per share (EPS) expected to touch remained 50.20% for this year while earning per share for the next 5-years is expected to reach at 12.00%. OPK has a gross margin of 37.90% and an operating margin of -21.30% while its profit margin remained -19.90% for the last 12 months.
According to the most recent quarter its current ratio was 1.1 that represents company’s ability to meet its current financial obligations. The price moved ahead of 4.28% from the mean of 20 days, -5.98% from mean of 50 days SMA and performed -34.38% from mean of 200 days price. Company’s performance for the week was 5.79%, 1.52% for month and YTD performance remained -33.22%.
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