WSJ: OPKO Shares Slide as Injection Doesn’t Top Placebo
Dec 31, 2016 14:33:14 GMT
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Post by gutset on Dec 31, 2016 14:33:14 GMT
OPKO Health Shares Slide as Injection Doesn’t Top Placebo in Trial
www.wsj.com/articles/opko-health-shares-slide-as-injection-doesnt-top-placebo-in-trial-1483108019
Disappointing late-stage trial of treatment for growth hormone deficiency sparks steep decline
Por AUSTEN HUFFORD
Updated Friday December 30, 2016 16:11 EDT
OPKO Health Inc. on Friday said its weekly injection to treat growth hormone deficiency failed to achieve its primary goal compared with a placebo in a late-stage trial, sending shares sharply lower.
The company’s long-acting human growth hormone, hGH-CTP, failed to statistically change the amount of torso fat, as compared with the placebo, over 26 weeks for 203 study participants.
OPKO is one of several drugmakers working to create a weekly growth injection hormone, which replace daily injections and hopefully increase patients’ compliance with their regimens.
The company said it identified one or more outliers that may have impacted the primary outcome of the phase-3 trial and said it is undertaking further review of the study population to try to see if any outliers can be excluded from the final analysis.
OPKO Executive Vice President Steven Rubin said he was confident the company will able to resubmit positive results to the FDA without rerunning the trial. He also said 80% of the market is with children, an age group not tested in this study.
OPKO said Friday it initiated a separate phase-3 study this month in pre-puberty children with growth hormone deficiency to evaluate weekly treatment with its drug versus daily injections of another.
Phase-3 clinical trials are typically the last phase before a drug seeks FDA approval.
The price of OPKO shares fell 20% to $9.20 in afternoon trading. Mr. Rubin called the stock move a “very significant overreaction.”
www.wsj.com/articles/opko-health-shares-slide-as-injection-doesnt-top-placebo-in-trial-1483108019
Disappointing late-stage trial of treatment for growth hormone deficiency sparks steep decline
Por AUSTEN HUFFORD
Updated Friday December 30, 2016 16:11 EDT
OPKO Health Inc. on Friday said its weekly injection to treat growth hormone deficiency failed to achieve its primary goal compared with a placebo in a late-stage trial, sending shares sharply lower.
The company’s long-acting human growth hormone, hGH-CTP, failed to statistically change the amount of torso fat, as compared with the placebo, over 26 weeks for 203 study participants.
OPKO is one of several drugmakers working to create a weekly growth injection hormone, which replace daily injections and hopefully increase patients’ compliance with their regimens.
The company said it identified one or more outliers that may have impacted the primary outcome of the phase-3 trial and said it is undertaking further review of the study population to try to see if any outliers can be excluded from the final analysis.
OPKO Executive Vice President Steven Rubin said he was confident the company will able to resubmit positive results to the FDA without rerunning the trial. He also said 80% of the market is with children, an age group not tested in this study.
OPKO said Friday it initiated a separate phase-3 study this month in pre-puberty children with growth hormone deficiency to evaluate weekly treatment with its drug versus daily injections of another.
Phase-3 clinical trials are typically the last phase before a drug seeks FDA approval.
The price of OPKO shares fell 20% to $9.20 in afternoon trading. Mr. Rubin called the stock move a “very significant overreaction.”
