Shares of Ampio Pharmaceuticals (NYSEMKT:AMPE) were jumping 8.4% as of 11:51 a.m. EST on Thursday. The nice gain came after the company provided its fourth-quarter update following the market close on Wednesday.
Investors probably didn't care all that much about Ampio's Q4 results. (For what it's worth, the drugmaker posted a net loss of $15.9 million, or $0.09 per diluted share, with no revenue.) Instead, the primary catalyst for the biotech stock was that Ampio provided additional clarity on where it stands with the U.S. Food and Drug Administration (FDA) on a couple of fronts.
Ampio CEO Michael Macaluso said that the FDA wants the company to conduct two phase 2 studies of its lead product Ampion before the agency will consider Emergency Use Authorization (EUA) for the drug in treating COVID-19. One of those studies is for the intravenous version of Ampion and the other for the inhaled version.
Macaluso also stated that Ampio has handed over a detailed proposal to the FDA for the continuation of its late-stage study of Ampion in treating osteoarthritis of the knee. This study has been paused due to the COVID-19 pandemic. Ampio seeks to analyze existing data for patients who had completed the 12-week regimen for use in filing for approval.
The FDA hasn't made a final decision on how Ampion can proceed with its late-stage study. Until the agency makes the call, the study will remain paused.