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OPKO Health (OPK) Begins RAYALDEE Phase 2 Clinical Trial

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OPKO Health, Inc. OPK recently announced that it has initiated a Phase 2 clinical trial to examine the efficacy of its flagship RAYALDEE platform for treating secondary hyperparathyroidism (SHPT) in adults with vitamin D deficiency and stage 5 chronic kidney diseases (CKD) requiring hemodialysis.

Per management, the clinical trial will be carried out at multiple dialysis centers across the United States in two cohorts. Both cohorts will be of 26 weeks’ duration. The first cohort will treat 44 patients while the second take care of 200 patients. Results of the first cohort are expected by 2019.

RAYALDEE Gains Prominence

Within OPKO Health’s pharmaceutical business, RAYALDEE has been the leading renal product in the U.S. market since the last couple of years.


RAYALDEE is the first and the only FDA approved therapy for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease. The platform has been witnessing a decent momentum, courtesy of successful efforts from the sales team.

In July, OPKO Health’s partner Vifor Fresenius Medical Care Renal Pharma (“VFMCRP”) received a regulatory approval from Health Canada to market RAYALDEE in the country. This development will enable treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) in Canada.

In the second quarter of 2018, OPKO Health recognized $4.8 million of revenues related to sales of RAYALDEE. Total RAYALDEE prescriptions skyrocketed approximately 467% on a year-over-year basis and surged 36% from the sequential quarter’s tally. For the third quarter of 2018, OPKO Health expects revenues for RAYALDEE between $5.7 million and $6.5 million.

Shares Lack Luster

Shares of OPKO Health have underperformed its industry in a year's time. The stock has lost almost 8.8%, wider than the industry’s decline of 8.3%. The current level is also against the S&P 500 index’s return of 17.4%.

The stock has a Zacks Rank #3 (Hold).

Want More From the Industry?

A few better-ranked stocks in the MedTech space are Penumbra, Inc PEN, Anika Therapeutics Inc. ANIK and Illumina, Inc ILMN, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Penumbra has an expected long-term earnings growth rate of 20% while the same for Anika Therapeutics and Illumina is pegged at 10% and 22.1%, respectively.

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