Opko Health Inc. (NYSE:OPK) has announced that it would be presenting at the vitamin-D workshop, underway in Boston. The company revealed that it would be presenting data from RAYADLEE, which is being tested as a secondary hyperparathyroidism treatment. OPK has prepared a poster for the presentation, which will be delivered by the lead author, Dr. Neil C. Binkley.
The study observed mean plasma levels of intact parathyroid hormone and mean ration of two serum levels. The results revealed that both levels fell with the treatment, to a level considered sufficient for patients with Chronic Kidney Disease. The study also showed that even after 26-weeks of treatment, the levels still indicated an insufficiency of vitamin D. However, the most significant revelation from the data was the fact that stage 3 and 4 CKD patients needed to reach a higher level of serum 25D, than was previously thought, in order to be considered sufficient.
Opko also faced some headwinds from the FDA, as the authority declined to approve a new drug by the company. Although it was anticipated that the FDA would grant OPK the approval on March 29, but due to deficiencies with third-party manufacturers the decision was delayed. It should be noted here that the FDA did not request additional studies of RAYADLEE, nor did it cite any safety of efficacy issues. Catalent Pharma, the third party in question and one of the largest contract manufacturer in the industry, has been asked to respond to the FDA’s concerns, with a plan of action, by April 15.
Even though the delay seems to be only temporary, OPK fell drastically in the stock market, despite optimistic views from analysts. Opko had planned to launch RAYADLEE during the 3Q2016. Some analysts have even stated that the event has created a buy opportunity, with quick returns, as the stock is expected to reach a target price of $20, after the drug has been approved.
Opko Health Inc. (NYSE:OPK) closed at a share price of $10.40, after gaining 5.05% during the March 31 session.