Opko Health Inc. (NASDAQ:OPK) announced that the Kidney Disease Improving Global Outcomes (KDIGO) organization has updated its Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD).

The update amends the 2009 KDIGO Clinical Practice Guideline and presents revised positions on current standards of care for the treatment of secondary hyperparathyroidism (SHPT) in patients with CKD stages 3 or 4:

  • Calcitriol and (1α-hydroxylated) vitamin D analogs: These therapies are no longer suggested for routine use and should be reserved for patients with stage 4 or 5 CKD with severe and progressive hyperparathyroidism.  The guideline notes that recent randomized clinical trials of calcitriol and its analogs failed to demonstrate improvements in outcomes but demonstrated increased risk of hypercalcemia, leading KDIGO to conclude that the risk-benefit ratio was no longer favorable for routine usage  in patients with stage 3 or 4 CKD.
  • Nutritional vitamin D: Supplementation with ergocalciferol or cholecalciferol remains unproven as a treatment for SHPT.

The updated guideline acknowledges Rayaldee® (extended release calcifediol) as a novel vitamin D prohormone and mentions that it both increases serum levels of 25-hydroxyvitamin D and lowers PTH in patients with stage 3 or 4 CKD.  Developed by OPKO Health, Rayaldee is the first and only FDA-approved extended-release prohormone to treat SHPT and it has a safety profile similar to that of placebo.1

“The updated guideline represents a needed shift in the way nephrologists manage secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease,” said  Michael J. Germain, MD, Professor of Medicine, Tufts University School of Medicine and Nephrologist/Partner, Western New England Renal & Transplant Associates, PC, Springfield, MA.  “SHPT is one of the most common complications of CKD and, unfortunately, it has also been historically difficult to treat due to a lack of an effective and appropriate, FDA-approved treatment option.  Having this updated guidance and the availability of an option like Rayaldee are significant advancements for both patients and providers managing this complex disease.”

“The updated KDIGO guideline highlights the unmet needs that exist in the treatment of SHPT, and we are working with physicians and other health care professionals to address these needs with Rayaldee,” said Charles W. Bishop, PhD, CEO of the OPKO Health Renal Division.

Shares of Opko are currently trading at $6.84, down $0.24 or -3.32%. OPK has a 1-year high of $12.15 and a 1-year low of $5.99. The stock’s 50-day moving average is $6.69 and its 200-day moving average is $8.26.

On the ratings front, Opko has been the subject of a number of recent research reports. In a report issued on June 16, Ladenburg Thalmann analyst Kevin Degeeter reiterated a Buy rating on OPK, with a price target of $19.50, which implies an upside of 175% from current levels. Separately, on June 12, Jefferies’ Eun Yang reiterated a Hold rating on the stock and has a price target of $8.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Kevin Degeeter and Eun Yang have a yearly average return of 7.6% and 4.8% respectively. Degeeter has a success rate of 53% and is ranked #1204 out of 4579 analysts, while Yang has a success rate of 53% and is ranked #637.

OPKO Health, Inc. is a diversified healthcare company. It operates through Diagnostics, and Pharmaceutical segments. The Diagnostics segment is consists of the pharmaceutical operates that the company acquired in Chile, Mexico, Ireland, Israel, and Spain and its pharmaceutical research and development operations. The Diagnostics segment is primarily comprised of the clinical and laboratory operations tit acquired through the acquisition of Bio-Reference and OPKO Lab and its point-of-care operations.