Opko Health, Miami-based biotech firm and one of South Florida’s largest public companies, reported Friday disappointing late-stage clinical trial results of a pharmaceutical product.
Shares of Opko Health (NYSE: OPK) plummeted nearly 20 percent following the report.
The Phase 3 trial of hGH-CTP, a human growth hormone drug, failed to produce a statistical difference from its placebo, the company said. However, Opko Health added that outliers may have impacted the outcome and trial patients will be reviewed again.
Now underway is a Phase 3 study using children as test subjects, aimed at measuring hGH-CTP’s efficacy in kids in lieu of daily injections of Genotropin, a prescription therapy for children and adults with growth issues.
Overall, Opko stock have gained 14 percent on the year, outpacing the S&P 500, which has gained 10 percent. Recently, the company was added to an exclusive Nasdaq index for biotech firms whose market capitalization, average trading volumes and other markets surpass a designated threshold, signaling its robust trajectory.
However, the company has encountered a bout of bad news in recent months, reporting a $15 million loss in the third quarter, beating Wall Street expectations of an even bigger downturn but churning out figures smaller than the same quarter last year.
A major Medicare administrative contractor also gave Opko's prostrate cancer screening test a "no coverage" decision in October, sending shares spiraling.
Analysts called the decision by Palmetto “a major setback” for Opko.
But the company also released in November Rayaldee, a drug aimed at treating secondary hyperparathyroidism in patients with chronic kidney disease and/or vitamin D deficiency.
Opko also broke into the pet products market, valued at about $60 billion in the U.S. by some estimates, in collaboration with its foreign counterparts, Opko Spain and Opko Ireland.
“Opko is in a unique position to offer health care products for companion animals with minimal investment by utilizing its existing product and manufacturing resources,” Chairman and CEO Frost said. “Opko intends to leverage its proprietary technologies to develop novel therapeutics to treat serious medical conditions in pets.”
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