AMGN · Earnings call · 2026Q3T · Full report

Product Launch and Transition

AMGEN INC · 2026-11-03 · Importance 26 · Surprise 24

Amgen said adoption of xaluritamig, its STEAP1-CD3 bispecific for prostate cancer, will depend on building familiarity and confidence among care teams, including urology groups and community practices. The company highlighted reduced monitoring and a Phase Ib fully outpatient cohort presented at ESMO as factors that could make administration more convenient; high STEAP1 expression may also allow treatment without confirmatory biomarker qualification. Amgen plans to apply its bispecific operations team, field medical presence, and patient-advocacy partnerships to GU oncology, drawing on experience with BLINCYTO and IMDELLTRA to support clinic operations, patient monitoring, and adoption.

Key facts

• TEPEZZA had launched in more than 20 countries worldwide, with 3 additional markets planned for the remainder of 2026.
• Amgen completed enrollment in both Phase III sleep apnea studies and its cardiovascular outcome study for MariTide, and initiated the first of 3 Phase III studies in type 2 diabetes.
• Amgen expected MariTide ultimately to be delivered using a patient-friendly, single-chamber handheld autoinjector.
• Amgen described MariTide as using a 3-step dose escalation, reaching the first maintenance dose in 2 months.
• Amgen plans to apply its bispecific operations team to the genitourinary oncology space.
• Amgen presented a Phase Ib fully outpatient cohort for xaluritamig at ESMO, demonstrating the feasibility of a more convenient administration setting.
• UPLIZNA was launched in 25 markets outside the U.S.
• Amgen said that high STEAP1 expression in prostate cancer may enable xaluritamig to be given without stratification or qualification by a confirmatory biomarker.