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.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->