Although the topline results of PALM 007 (studying SIGA’s tecovirimat in the treatment of mpox) did not meet the statistical significance for the full population (primary endpoint), we are encouraged by the clinically meaningful benefit reported over placebo in early-treated patients and in those with severe disease. The data highlight an opportunity to establish an effective regime for these key populations, given the lack of effective treatment options and the overall importance of early treatment in infectious diseases. PALM 007 was not a registrational study, and SIGA’s priorities in mpox are the four remaining ongoing studies targeting this indication, which may potentially support a mpox label in the US. Currently, tecovirimat is approved for mpox treatment in the EU and UK.