Shares of Opko Health OPK are up nearly 5.5% in morning trading Tuesday following the news that the FDA has approved its new treatment for secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease.
Opko's new drug, named Rayaldee, will come in the form of extended release capsules and should debut in the market by the second half of the fiscal year.
"FDA's approval of RAYALDEE represents an important milestone for OPKO," said Opko CEO Dr. Phillip Frost in a statement . "RAYALDEE is the first product to receive FDA approval for this important indication and is one of OPKO's many pharmaceutical products being developed for significant medical problems which will benefit from new treatment options."
Rayaldee was expected to be approved back in March, but the FDA delayed the approval based on deficiencies at a third-party manufacturer. Although treatments for secondary hyperparathyroidism exist, Rayaldee should be even more accessible.
"RAYALDEE fills a large void in the current treatment options for SHPT in predialysis patients," said Dr. Charles W. Bishop, CEO of OPKO's Renal Division. "The current standard of care is high dose vitamin D supplementation, an approach for treating SHPT that is neither FDA approved nor demonstrated to be safe and effective in this population."
Opko currently has a Zacks Rank #3 (Hold), but an approval of this significance could help the stock move. The company currently holds "A" grades for both Growth and Momentum in our Style Scores system, which indicates that Opko could have the potential to be a quality pick soon.