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Ampio Pharmaceuticals shares plunge below US$1 after FDA rejects key drug license application

The FDA wants an additional randomized trial to evaluate the drug Ampion, a treatment for pain caused by osteoarthritis of the knee
The FDA said Ampio's current trial for Ampion doesn't support an application for a key license

Shares of Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) endured a rough run Wednesday after the biopharma group announced that the US Food and Drug Administration will not provide a biologics license application (BLA) for Ampion, its treatment for pain caused by osteoarthritis of the knee.

The FDA said that as a single trial, Ampio’s AP-003 A study – which evaluated Ampion – does not appear on its own to provide sufficient evidence of effectiveness to support a BLA, according to a regulatory filing with the Securities and Exchange Commission.

The FDA has recommended that Ampio pursue an additional randomized trial to measure the effectiveness of Ampion.

The news disappointed investors, who pushed Ampio shares down below the key US$1 threshold as they fell 68% to US$0.91 in early afternoon trade.

“Despite our belief that the APC-003 C trial design was based on FDA guidance and feedback and consistent with FDA precedent for similar products (in intended use, in origin, and in regulatory pathway), which we reiterated with the FDA multiple times, the FDA does not consider the AP-003 C trial to be an adequate and well-controlled clinical trial,” Ampio said in a statement filed with the SEC.

Contact Ellen Kelleher at [email protected]

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