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.
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 19,000+ biopharma pros who read Endpoints News by email every day.Free Subscription