AMGN · 10-Q · 2026Q3 · Full report
Product Pipeline Progress
AMGEN INC · 2026-11-04 · Importance 34 · Surprise 42 · In source text
In August 2026, TEZSPIRE met co-primary and key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with improvements sustained through week 52. The European Commission expanded Repatha’s indication for cardiovascular risk reduction in adults with established or high-risk ASCVD, based on VESALIUS-CV results. IMDELLTRA/IMDYLLTRA plus IMFINZI improved overall survival in the Phase 3 DeLLphi-305 study as first-line maintenance treatment for extensive-stage small cell lung cancer; dazodalibep met its primary endpoint in the Phase 3 OASIZ 301 study in adults with Sjögren’s disease. Amgen submitted ABP 206, a biosimilar candidate to OPDIVO, for FDA review, and its ABP 234 comparative clinical study against KEYTRUDA met both primary and secondary endpoints.
Key facts
- Amgen and AstraZeneca announced positive top-line Phase 3 CROSSING trial results for TEZSPIRE in eosinophilic esophagitis in August 2026; the drug showed statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24, sustained through week 52. source
- The European Commission approved an expanded Repatha indication in August 2026 for adults with established or high-risk ASCVD to reduce cardiovascular risk by lowering LDL-C, based on Phase 3 VESALIUS-CV results. source
- In September 2026, Amgen announced that the Phase 3 DeLLphi-305 study met its primary endpoint at a prespecified interim analysis, showing statistically significant and clinically meaningful overall survival improvement with IMDELLTRA/IMDYLLTRA plus IMFINZI versus IMFINZI alone. source
- DeLLphi-305 also showed statistically significant and clinically meaningful improvement in progression-free survival and objective response rate with IMDELLTRA/IMDYLLTRA plus IMFINZI. source
- In September 2026, Amgen announced that Phase 3 OASIZ 301 met its primary endpoint, showing statistically significant and clinically meaningful improvement at week 48 on ESSDAI in adults with Sjögren’s disease and moderate-to-severe systemic disease activity. source
- In September 2026, Amgen announced submission of its ABP 206 biosimilar Biologics License Application and FDA acceptance for review. source
- Bristol-Myers Squibb and co-plaintiffs sued Amgen on September 8, 2026, alleging infringement of seven patents through Amgen’s ABP 206 biosimilar application and seeking declaratory judgment of infringement; Amgen’s response was due November 13, 2026. source
- In September 2026, Amgen announced that the primary analysis of the ABP 234 pharmacokinetic/comparative clinical study was complete and met both primary and secondary endpoints. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | Amgen and AstraZeneca announced positive top-line Phase 3 CROSSING trial results for TEZSPIRE in eosinophilic esophagitis in August 2026;… |
| revenue | positive | probable | — | The European Commission approved an expanded Repatha indication in August 2026 for adults with established or high-risk ASCVD to reduce… |
| revenue | positive | contingent | — | In September 2026, Amgen announced that the Phase 3 DeLLphi-305 study met its primary endpoint at a prespecified interim analysis, showing… |
| revenue | positive | contingent | — | In September 2026, Amgen announced that Phase 3 OASIZ 301 met its primary endpoint, showing statistically significant and clinically… |
| revenue | positive | contingent | — | In September 2026, Amgen announced submission of its ABP 206 biosimilar Biologics License Application and FDA acceptance for review. |
| liability | negative | contingent | — | Bristol-Myers Squibb and co-plaintiffs sued Amgen on September 8, 2026, alleging infringement of seven patents through Amgen’s ABP 206… |