Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis

Eli Lilly (NYSE:LLY) reported that its drug Omvoh met the primary endpoint in a Phase 3 study for pediatric ulcerative colitis. The SHINE-2 study showed 81% of patients achieved clinical response at Week 12, with 50% of responders in clinical remission at Week 52. The company plans to submit the data to global regulators for potential label expansion. Omvoh is already approved for adults in 47 countries.

Lilly reported positive results from its SHINE-2 trial, showing 81% of pediatric ulcerative colitis patients responded to Omvoh (mirikizumab) treatment. Key outcomes included 50% clinical remission and 50% corticosteroid-free remission. Lilly plans to submit these data to regulators for potential label expansion. Omvoh is currently approved for adults with ulcerative colitis.

AstraZeneca withdrew its EU application for Truqap in prostate cancer. Orphelia Pharma gained CHMP backing for Kizfizo in glioblastoma. Ascendis Pharma neared EU approval for Yuviwel in achondroplasia. Sobi expanded Tryngolza's use to severe hypertriglyceridemia. Pfizer withdrew Ibrance's EU expansion. Revolution Medicines got CHMP backing for Rasonque in pancreatic cancer. Omeros failed to overturn Yartemlea's EU rejection. Lilly advanced Foundayo for obesity and diabetes in Europe.

Pennsylvania's attorney general sued Eli Lilly, Novo Nordisk, Sanofi, and PBMs like Express Scripts, CVS Caremark, and Optum RX, alleging they colluded to inflate insulin prices by over 1,000%. The lawsuit seeks lower prices and restitution for affected residents. Similar lawsuits have been filed in Oregon and Florida.

Eli Lilly's anti-obesity pill, Foundayo, received a favorable opinion from the EMA's committee. The drug generated $98M in Q2 sales and could launch in Europe by year-end. Eli Lilly aims to compete with Novo Nordisk's Wegovy in a market projected to exceed $100B by 2030.

Divi’s Laboratories shares rose 2% after an EU panel recommended approval for Eli Lilly’s weight-loss pill, Foundayo. The company, which manufactures pharmaceutical ingredients, reported a 65.5% increase in Q2 net profit to Rs 902 crore. Divi’s has not announced any role in the drug. The stock traded at Rs 9,241.00 on NSE.