Opko Health Inc. (NASDAQ:OPK) announces an update to the topline data analysis of the Phase 3, double-blind, placebo-controlled study of its investigational long-acting human growth hormone product (hGH-CTP) in adults with growth hormone deficiency (GHD). In December 2016 OPKO reported that the primary endpoint of change in trunk fat mass from baseline to 26 weeks did not demonstrate a statistical difference between the hGH-CTP treated group and placebo. At the time, one or more outliers were identified that may have affected the outcome on the primary endpoint.
OPKO has now completed post-hoc sensitivity analyses to evaluate the influence of outliers on the primary endpoint results using multiple statistical approaches. Analyses that excluded outliers showed a statistically significant difference between hGH-CTP and placebo on the change in trunk fat mass. Additional analyses that did not exclude outliers showed mixed results. Post-hoc analyses do not carry the same weight of evidence as a pre-specified primary analysis.
“We are encouraged by the results of these analyses,” stated Phillip Frost, M.D., OPKO Chairman and Chief Executive Officer.
OPKO has initiated a global Phase 3 trial, utilizing a multi-dose disposable pre-filled pen, to evaluate hGH-CTP in pediatric GHD patients. OPKO also plans to utilize this multi-dose pen for patients who continue in the open label extension phase of the adult Phase 3 and the pediatric Phase 2 GHD studies. In addition, preparation for the pivotal pediatric GHD trial in Japan is progressing and site selection is near completion.
Shares of Opko Health are currently trading at $6.41, down $0.11 or -1.61%. OPK has a 1-year high of $12.15 and a 1-year low of $5.99. The stock’s 50-day moving average is $6.84 and its 200-day moving average is $8.40.
On the ratings front, OPK has been the subject of a number of recent research reports. In a report issued on June 12, Jefferies Co. analyst Eun Yang reiterated a Hold rating on OPK, with a price target of $8, which implies an upside of 25% from current levels. Separately, on June 6, Ladenburg Thalmann’s Kevin Degeeter reiterated a Buy rating on the stock and has a price target of $19.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eun Yang and Kevin Degeeter have a yearly average return of 2.2% and 7% respectively. Yang has a success rate of 47% and is ranked #1420 out of 4574 analysts, while Degeeter has a success rate of 51% and is ranked #1295.
OPKO Health, Inc. is a diversified healthcare company. It operates through Diagnostics, and Pharmaceutical segments. The Diagnostics segment is consists of the pharmaceutical operates that the company acquired in Chile, Mexico, Ireland, Israel, and Spain and its pharmaceutical research and development operations. The Diagnostics segment is primarily comprised of the clinical and laboratory operations tit acquired through the acquisition of Bio-Reference and OPKO Lab and its point-of-care operations.