LLY · 10-Q · 2026Q2 · Full report
Regulatory Approval Milestones
ELI LILLY & Co · 2026-08-05 · Importance 47 · Surprise 60 · In source text
The FDA approved orforglipron, marketed as Foundayo, for obesity, and Lilly launched it in the U.S. during the second quarter of 2026. Lilly submitted orforglipron for type 2 diabetes in the U.S., European Union, and Japan. The EU’s CHMP issued a positive opinion recommending insulin efsitora alfa for type 2 diabetes, while Phase 3 trials began for eloralintide in obesity, obstructive sleep apnea, and osteoarthritis pain, and for other pipeline assets. Phase 3 trials for retatrutide met primary endpoints in obesity and type 2 diabetes, and sofetabart mipitecan received FDA Breakthrough Therapy designation for certain platinum-resistant ovarian cancer patients.
Key facts
- The FDA approved orforglipron (Foundayo) for treatment of obesity. source
- Insulin efsitora alfa received a positive opinion from the CHMP recommending it for treatment of type 2 diabetes in the EU. source
- The FDA granted Breakthrough Therapy designation for sofetabart mipitecan for treatment of certain patients with platinum-resistant ovarian cancer. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | The FDA approved orforglipron (Foundayo) for treatment of obesity. |
| revenue | positive | probable | — | Insulin efsitora alfa received a positive opinion from the CHMP recommending it for treatment of type 2 diabetes in the EU. |
| revenue | positive | contingent | — | The FDA granted Breakthrough Therapy designation for sofetabart mipitecan for treatment of certain patients with platinum-resistant… |