AMGN · 8-K · 20260804PR000124
Product Pipeline Progress
AMGEN INC · 2026-08-04 · Importance 31 · Surprise 42 · No source text
Amgen continued Phase 3 development of MariTide across chronic weight management, cardiovascular outcomes, heart failure, obstructive sleep apnea, and switching from tirzepatide or semaglutide, with three additional Phase 3 T2D studies planned to start in 2026. The company discontinued future development of AMG 513, while continuing a Phase 1 study to follow enrolled obesity participants through completion. IMDELLTRA received European Commission approval in May for post-platinum extensive-stage small-cell lung cancer and full China NMPA approval for second-line disease, with commercialization in China by BeOne. A Phase 3 subcutaneous tarlatamab study, DeLLphi-315, was initiated in second-line extensive-stage small-cell lung cancer, while two subcutaneous blinatumomab studies paused enrollment after a partial FDA clinical hold.
Key facts
- Three Phase 3 studies of MariTide in people living with T2D will be initiated in 2026. source
- A Phase 3 study of UPLIZNA in chronic inflammatory demyelinating polyneuropathy (CIDP) will be initiated H2 2026 - H1 2027. source
- Future development of AMG 513 will be discontinued, but a Phase 1 study of AMG 513 in adults living with obesity will remain ongoing to follow enrolled participants through completion of the study. source
- MERCURY, a Phase 2/3 study of UPLIZNA, was initiated in patients with autoimmune hepatitis (AIH). source
- Two Phase 3 studies of dazodalibep in Sjögren’s disease are underway and completion of both studies is expected in H2 2026. source
- A Phase 3 study of TEZSPIRE in eosinophilic esophagitis is ongoing with study completion expected in H2 2026. source
- Sunakiment LEVANTE Phase 2 asthma study is complete and the Company, in collaboration with AstraZeneca, is planning a Phase 3 development program in asthma. source
- Blinatumomab Phase 2 studies in autoimmune disease are enrolling adults with refractory rheumatoid arthritis and ongoing in adults with systemic lupus erythematosus with and without nephritis. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| operating_income | negative | probable | — | Three Phase 3 studies of MariTide in people living with T2D will be initiated in 2026. |
| operating_income | negative | probable | — | A Phase 3 study of UPLIZNA in chronic inflammatory demyelinating polyneuropathy (CIDP) will be initiated H2 2026 - H1 2027. |
| operating_income | positive | probable | — | Future development of AMG 513 will be discontinued, but a Phase 1 study of AMG 513 in adults living with obesity will remain ongoing to… |
| operating_income | negative | probable | — | MERCURY, a Phase 2/3 study of UPLIZNA, was initiated in patients with autoimmune hepatitis (AIH). |
| operating_income | negative | probable | — | Two Phase 3 studies of dazodalibep in Sjögren’s disease are underway and completion of both studies is expected in H2 2026. |
| operating_income | negative | probable | — | A Phase 3 study of TEZSPIRE in eosinophilic esophagitis is ongoing with study completion expected in H2 2026. |
| operating_income | negative | probable | — | Sunakiment LEVANTE Phase 2 asthma study is complete and the Company, in collaboration with AstraZeneca, is planning a Phase 3 development… |