Pfizer partner Opko reports a PhIII failure for growth hormone, but tries to steer out of a crash

Opko Health $OPK reported that its long acting growth hormone — partnered with Pfizer — failed a Phase III study. But the biotech tried to steer out of a crash by claiming that it may have identified “outliers” in the study that could explain the flop as something other than a flop.

“On the primary endpoint of change in trunk fat mass from baseline to 26 weeks, there was no statistical difference between hGH-CTP and placebo,” Opko reported. “However, after unblinding the study, Opko identified one or more outliers that may have affected the primary outcome. As a result, Opko is undertaking further review of the study population as promptly as possible.”

Shares of Opko dropped 18.5% on the news by early afternoon, wiping out more than $1 billion in market cap.

That’s bad news for Pfizer, which paid $295 million upfront and promised up to $275 million more in regulatory milestones for this program. The therapy aimed at replacing once-daily injections for a once-weekly approach.

Opko picked up the program from its $480 million all-stock buyout of Israel’s Prolor in 2013. Opko recruited 203 adults with growth hormone deficiency for the study.

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Biotech Investment Analyst
SV Health Investors Boston, MA
Director, Program Management
Contrafect Corporation New York, NY
Director, Translational Sciences
Cadent Therapeutics Cambridge, MA

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