Drug Development

Ampio shares are routed (again) as its PhIII do-over for osteoarthritis flops

Last April little Ampio Pharmaceuticals $AMPE struggled to put the best face on the Phase III failure of its osteoarthritis drug Ampion. The dread placebo effect scuttled the study, execs protested, as its stock was crushed in the instant rout.

By last fall, though, the Englewood, CO-based biotech came back with a new Phase III, significantly de-risked, they said, based on prior results and a special protocol assessment with the FDA that put success within their grasp.

It didn’t work out as planned, though.

The biotech was forced to admit this morning that the second Phase III failed like the first. And as it sought to reassure investors of the way forward, little Ampio saw its shares crushed again, this time plunging 61% in the latest rout.

Ampio ended the day with a market cap at $67 million. In after-hours trading, its stock slipped 5% more.

“Ampio has the opportunity to provide treatment where there is a clear unmet medical need,” claimed CEO Michael Macaluso. “Even though we did not meet the primary endpoint in the PIVOT study, we are pleased with the consistent effect Ampion demonstrated in all of our clinical trials. Ampio is requesting a meeting with the FDA to present our data in support of Ampion.”

Regulators typically don’t have much tolerance for two-time losers. But we’ll keep you posted on the next chapter for Ampio.

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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

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