AMGN · Earnings call · 2026Q3T · Full report

Regulatory Approval Milestones

AMGEN INC · 2026-11-03 · Importance 47 · Surprise 60

The FDA recently shortened the recommended monitoring period for IMDELLTRA’s first two doses from 22–24 hours to 6–8 hours, reducing the burden of initiating treatment in community oncology settings. Amgen said the change is helping community clinics initiate second-line patients and is pursuing further label improvement for the first-line maintenance setting, where the DeLLphi-305 study used 1–2 hours of monitoring. The company is working to file the first-line maintenance data with regulatory authorities around the world.

Key facts

• The FDA shortened the recommended monitoring period for IMDELLTRA's first 2 doses from 22 to 24 hours to 6 to 8 hours.
• Amgen reported positive Phase III results for IMDELLTRA in small cell lung cancer, TEZSPIRE in eosinophilic esophagitis, and dazodalibep in Sjogren's disease.
• Phase III results for TEZSPIRE in chronic rhinosinusitis with nasal polyps showed improved disease control and reduced need for surgery.
• In the TEZSPIRE Phase III CROSSING study, both co-primary endpoints were met at week 24, showing improved histologic remission and swallowing symptoms versus placebo; benefits were sustained through week 52.
• Amgen planned to advance daxdilimab into Phase III development following positive Phase II results.
• If approved in first-line maintenance, Amgen estimated IMDELLTRA could address 23,000 patients in the U.S. alone.
• Amgen said the CROSSING study was the first placebo-controlled EoE biologic trial to show sustained efficacy through 52 weeks.
• Amgen's Phase II daxdilimab study showed week-24 CLASI-A improvement of 10.2 points at the lower dose and 9.9 points at the higher dose; placebo-adjusted improvements were 6.0 and 5.7 points.