Opko Health Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review OPKO’s New Drug Application (NDA) for calcifediol modified-release capsules (proposed trade name, Rayaldee™). In the NDA, OPKO seeks approval of 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.
“FDA acceptance of this NDA should be cheered by healthcare professionals who care for CKD patients,” commented Dr. Kevin J. Martin, Director of theDivision of Nephrology at Saint Louis University School of Medicine. “If approved, Rayaldee will provide a new therapeutic option for controlling elevated parathyroid hormone levels in this large and undertreated patient population.”
OPKO expects written notification of NDA acceptance along with the Prescription Drug User Fee Act (PDUFA) date in the FDA’s 74-Day letter, which the Company expects to receive by mid-August 2015.
The NDA is supported by 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. (Original Source)
Shares of Opko Health opened today at $16.72 and are currently trading up 2.35% at $16.99. OPK has a 1-year high of $19.20 and a 1-year low of $8.02. The stock’s 50-day moving average is $16.15 and its 200-day moving average is $14.76.
On the ratings front, Oppenheimer analyst Rohit Vanjani maintained a Hold rating on OPK, in a report issued on May 12. According to TipRanks.com, Vanjani has a total average return of 42%, an 81.7% success rate, and is ranked #7 out of 3717 analysts.
Opko Health Inc is a biopharmaceutical and diagnostics company. The Company is engaged in the research and development of pharmaceutical products and vaccines.