FDA accepts OPKO's Rayaldee NDA for SHPT

• The FDA accepts for review the New Drug Application (NDA) from OPKO Health (OPK +2.4%) for Rayaldee (calcifediol) for the treatment and prevention of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
• The PDUFA date will be announced when the company receives its 74-Day letter in mid-August.
• There are ~4M Americans with stage 3 or 4 CKD and vitamin D insufficiency.