FDA moving to one trial for approval could be positve for MoonLake, says Cantor

STAT reports that the FDA plans to shift toward requiring only one pivotal trial for approval rather than the traditional two, though details and timing remain unclear pending formal agency communication, Cantor Fitzgerald analyst Prakhar Agrawal tells investors in a research note. While the policy could have broad sector implications, it meaningfully boosts the likelihood of MoonLake’s sonelokimab securing hidradenitis suppurativa approval based on a single positive pivotal study, the analyst says. Cantor has an Overweight rating on MoonLake shares.