Opko Health Stumbles Over FDA Letter

Opko Health Inc. (NYSE: OPK) saw its shares slide in Wednesday’s regular trading session following the release of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). The company announced that FDA has issued a CRL regarding the company’s New Drug Application (NDA) for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease 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, as a result of an FDA field inspection initiated on March 14. 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. In the CRL, FDA has reconfirmed the acceptance of the proprietary name Rayaldee. The FDA also reached agreement with Opko for an approvable package insert and all container labeling.
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Phillip Frost, M.D., chairman and chief executive of Opko, commented:

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. We will continue to build our commercial sales organization in preparation for the earliest possible Rayaldee launch.

So far in 2016, Opko has outperformed the broad markets, with the stock up 10%. Over the past 52 weeks, the stock is actually down 23%.

Shares of Opko were trading down 7.6% at $10.23 on Wednesday, with a consensus analyst price target of $16.80 and a 52-week trading range of $7.12 to $19.20.