Rezolute is trading at $4.63, up 6.99% in pre-market after the FDA recommended a pre-BLA meeting for ersodetug on October 5, following its review of sunRIZE data.
- The Phase 3 sunRIZE trial missed its primary and key secondary endpoints; the recommendation is a constructive regulatory step, not an approval decision or guarantee of approvability.
- On October 6, Citizens raised its price target to $15 from $11, citing FDA feedback and maintaining Market Outperform.