Eli Lilly announced positive Phase 3 SHINE-2 trial results for Omvoh in pediatric ulcerative colitis, achieving an 81% response rate at 12 weeks and a 50% clinical remission rate at one year. The results support Eli Lilly's planned regulatory submissions seeking label expansion, positioning Omvoh to potentially become the first approved IL-23p19 inhibitor for children with the condition. The clinical milestone, combined with a $1.1 billion AI delivery partnership, drove Eli Lilly stock up 3.7%.
SHINE-2 trial efficacy results
- ▪In Eli Lilly's Phase 3 SHINE-2 trial, 81% of pediatric ulcerative colitis patients achieved a clinical response after 12 weeks of induction treatment with Omvoh.
- ▪At Week 52 in the SHINE-2 trial, 50% of pediatric patients achieved corticosteroid-free remission and 44% achieved endoscopic remission on Omvoh.
- ▪Among Week 12 clinical responders in the SHINE-2 trial, 50% of pediatric ulcerative colitis patients achieved clinical remission after one year of treatment with Omvoh.
- ▪Fecal calprotectin levels among pediatric ulcerative colitis patients in the SHINE-2 study decreased by 1,229.9 µg/g from baseline to Week 12 following mirikizumab induction.
SHINE-2 trial patient population
- ▪Half of the pediatric patients enrolled in the SHINE-2 trial met the modified Mayo score criteria for severe ulcerative colitis.
- ▪The Phase 3 SHINE-2 trial enrolled 63 pediatric patients with moderately to severely active ulcerative colitis, more than half of whom had previously failed another biologic or advanced therapy.
SHINE-2 trial dosing regimen
- ▪Pediatric patients in the SHINE-2 trial received three weight-based intravenous induction doses of mirikizumab at 4-week intervals, followed by monthly subcutaneous maintenance injections.
- ▪In the SHINE-2 trial, mirikizumab intravenous induction doses ranged from 5 mg/kg for patients under 40 kg to 300 mg for those over 40 kg, with maintenance doses between 50 mg and 200 mg based on weight.
Omvoh pediatric regulatory plans and potential
- ▪Eli Lilly plans to submit Phase 3 SHINE-2 trial data to the FDA and global regulatory authorities to apply for a pediatric label expansion for Omvoh.
- ▪If approved by regulatory authorities for pediatric ulcerative colitis, Omvoh would become the first IL-23p19 inhibitor available for children with the condition.
Stelara pediatric trial results and approval
- ▪Johnson & Johnson's Stelara received FDA approvals in 2026 for pediatric Crohn's disease and ulcerative colitis in children as young as two years old.
- ▪In its phase 3 trial, Johnson & Johnson's Stelara achieved a 40% clinical remission rate at 52 weeks in pediatric ulcerative colitis.
Eli Lilly stock movement and analyst ratings
- ▪Eli Lilly shares rose 3.7% to $1,286.61 on October 20, 2026, supported by positive SHINE-2 trial results and a $1.1 billion strategic partnership with JT Therapeutics.
- ▪Cantor Fitzgerald raised its price target on Eli Lilly stock to $1,440 while maintaining an Overweight rating on October 20, 2026.
Story comments
Loading comments…