Rezolute is trading at $4.22, up 5.24%, with the FDA’s pre-BLA meeting recommendation for ersodetug the clearest explanation for the gain. - On October 5, Rezolute announced the FDA recommendation, a step toward a potential congenital hyperinsulinism application. - The Phase 3 study missed its prespecified primary and key secondary endpoints; the FDA did not comment on approvability. Broader indexes were also higher, but the move is not attributed to them.