LLY News & Events

Eli Lilly and Company (LLY) and Incyte (INCY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Olumiant for the treatment of adolescents with severe alopecia areata. AA is a chronic immune disease that can have an especially devastating social and emotional impact on young patients and their families, as early onset AA can be more severe and lead to extensive and unpredictable hair loss. Lilly has also submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026.

Soleno Therapeutics (SLNO) announced the appointment of Jennifer Fulk as Chief Financial Officer, succeeding James Mackaness, who announced that he will be retiring from the Company by the end of the first quarter. Mackaness will serve as a consultant to Soleno through the end of the year to ensure a smooth transition. Fulk brings to Soleno more than two decades of public company experience, with a career progression that includes 15 years at Eli Lilly (LLY).

Eli Lilly announced results from ACHIEVE-3, the first head-to-head Phase 3 trial evaluating the safety and efficacy of orforglipron, a small molecule oral GLP-1 without food or water restrictions, compared with oral semaglutide in adults with type 2 diabetes inadequately controlled with metformin. The 52-week trial enrolled 1,698 participants across four treatment arms: orforglipron 12 mg and 36 mg, and oral semaglutide 7 mg and 14 mg. In ACHIEVE-3, orforglipron outperformed oral semaglutide across the primary and all key secondary endpoints, delivering significantly greater improvements in A1C and weight. The results were published today in The Lancet. Orforglipron also showed clinically meaningful improvements from baseline across key cardiovascular risk factors, including non-HDL cholesterol, HDL cholesterol, VLDL cholesterol, total cholesterol, systolic blood pressure and triglycerides. The overall safety and tolerability profile of orforglipron in ACHIEVE-3 was consistent with previous trials. For orforglipron and oral semaglutide, the most common adverse events were nausea, diarrhea, vomiting, dyspepsia and decreased appetite. Treatment discontinuation rates due to adverse events were 8.7% and 9.7% for orforglipron vs. 4.5% and 4.9% for oral semaglutide. Lilly has submitted orforglipron to regulators in over 40 countries, with submission for type 2 diabetes in the U.S. planned later this year.