Health and Healthcare

Ampio Crashes After Late-Stage Trial Failure

Chris Lange

Published: June 30, 2016 1:42 pm

Last Updated: January 13, 2020 6:11 am

Ampio Pharmaceuticals, Inc. (NYSEMKT: AMPE) is watching its shares get cut in half on Thursday after news of a failed late-stage trial. The company announced the results of its Ampion PIVOT clinical trial as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the U.S. Food and Drug Administration (FDA). However the primary endpoint was not met.

Ampion was demonstrated to be safe and well-tolerated with no drug-related serious AEs and an overall AE rate that was similar in the Ampion and saline groups.

Going forward the company will request a meeting with the FDA for approval regarding its treatment of pain due to severe osteoarthritis of the knee.

Michael Macaluso, CEO of Ampio Pharma, commented:

Ampio has the opportunity to provide treatment where there is a clear unmet medical need. Even though we did not meet the primary end point 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.

Excluding Thursday’s move, Ampio has underperformed the broad markets with the stock down 5% year to date. However over the past 52-weeks the stock is up 40%.

Shares of Ampio were last trading down nearly 60% at $1.36, with a consensus analyst price target of $14.00 and a 52-week trading range of $0.84 to $4.32.