Opko Health Inc. (NYSE:OPK) announces that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the Company’s New Drug Application (NDA) for RAYALDEE® (calcifediol) as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

The FDA indicated in the CRL that observations of deficiencies at OPKO’s third-party contract manufacturer were issued on March 25, 2016 as a result of an FDA field inspection initiated on March 14, 2016. The observations were not specific to RAYALDEE manufacturing. The CRL did not cite any safety, efficacy or labeling issues with regard to RAYALDEE, nor did it request any additional studies to be conducted prior to FDA approval.

The Company’s third-party manufacturer has committed to respond promptly to the FDA’s observations to ensure early resolution.

In the CRL, FDA has re-confirmed the acceptance of the proprietary name RAYALDEE. The FDA also reached agreement with OPKO for an approvable package insert and all container labeling.

“OPKO is committed to bringing RAYALDEE to patients who will benefit from its intended use and will work closely with the FDA and our third-party manufacturer to ensure that the inspection observations are promptly and fully addressed,” noted Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “We will continue to build our commercial sales organization in preparation for the earliest possible RAYALDEE launch.” (Original Source)

Shares of Opko Health are down nearly 9% in pre-market trading. OPK has a 1-year high of $19.20 and a 1-year low of $7.12. The stock’s 50-day moving average is $9.68 and its 200-day moving average is $9.59.

On the ratings front, Opko Health has been the subject of a number of recent research reports. In a report issued on March 15, Jefferies Co. analyst Brandon Couillard reiterated a Hold rating on OPK. Separately, on March 1, Oppenheimer’s Rohit Vanjani maintained a Hold rating on the stock .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brandon Couillard and Rohit Vanjani have a total average return of 9.8% and 10.7% respectively. Couillard has a success rate of 71.3% and is ranked #251 out of 3766 analysts, while Vanjani has a success rate of 50.8% and is ranked #232.

Opko Health Inc is a biopharmaceutical and diagnostics company. The Company is engaged in the research and development of pharmaceutical products and vaccines.