Opko Health (OPK) is one of today’s notable pre-market movers, up as much as $0.74, or 8 percent. The surge follows the FDA’s approval of the company’s drug, Rayaldee. The drug is used in treating secondary hyperparathyroidism associated with vitamin D insufficiency in patients with stage 3 and 4 chronic kidney disease.
“FDA’s approval of Rayaldee represents an important milestone for OPKO,” said in a statement Dr. Phillip Frost, CEO and Chairman of OPKO. “Rayaldeeis 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.”
With Tuesday’s approval, the FDA expects to launch the drug later this year.
In the past 52 weeks, shares of Miami, Florida-based biopharmaceutical and diagnostics company have traded between a low of $7.12 and a high of $17.51.
Shares are down 40.71% year-over-year and 8.56% year-to-date.
Opko’s stock closed up 1.55% at $9.19 in Monday’s trading session.