Opko Health Inc. (NYSE: OPK) announced that it has submitted a New Drug Application (NDA) for oral Rayaldee to the U.S. Food and Drug Administration (FDA). The NDA requests marketing approval for Rayaldee for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
“The submission of this NDA represents a significant milestone in the development of Rayaldee, and it underscores our strong commitment to making improved therapies available to patients who suffer from chronic kidney disease,” commented Dr. Phillip Frost, CEO and Chairman of OPKO. “We believe Rayaldee will be the first product to receive FDA approval for this important indication.”
The Rayaldee application is supported by positive data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints, as previously announced.
Shares of Opko Health opened today at $17.72 and are currently trading down at $17.7. OPK has a 1-year high of $18.29 and a 1-year low of $8.02. The stock’s 50-day moving average is $15.30 and its 200-day moving average is $12.52.
On the ratings front, Opko has been the subject of a number of recent research reports. In a report issued on May 12, Oppenheimer analyst Rohit Vanjani maintained a Hold rating on OPK. Separately, on March 26, Barrington Research’s Michael Petusky initiated coverage with a Buy rating on the stock and has a price target of $19.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Rohit Vanjani and Michael Petusky have a total average return of 35.3% and 12.0% respectively. Vanjani has a success rate of 75.6% and is ranked #29 out of 3610 analysts, while Petusky has a success rate of 66.7% and is ranked #1187.
Opko Health Inc is a biopharmaceutical and diagnostics company. The Company is engaged in the research and development of pharmaceutical products and vaccines.