Rezolute is trading 10.99% up at $4.45 after the FDA recommended a pre-BLA meeting for ersodetug. - The October 5, 2026, gain followed the recommendation, which came after review of Phase 3 sunRIZE data. - The trial missed its prespecified primary and key secondary endpoints. - The meeting is a step toward a potential application for congenital hyperinsulinism. The FDA expressed no opinion on approval; that would be assessed in a formal BLA review.