ET 15:11

Amgen's Dazodalibep Hits Phase 3 Goal in Sjögren's; Shares Rise 5%

IMP6.0
SNT+0.6
CONF90%
Operational

Amgen shares climbed as much as 5% on Tuesday, Sept. 22, 2026, after the company said its experimental drug dazodalibep met the primary objective in the first of two Phase 3 trials in Sjögren's syndrome. The California biotechnology company reported a "statistically significant and clinically meaningful improvement" in a widely used disease activity measure at 48 weeks, with effects observed as early as four weeks. It did not disclose detailed data, which will be presented at a future medical meeting. Investigators found no imbalance in blood clots or opportunistic infections, and side effects were generally mild to moderate. No approved therapies can alter the course of Sjögren's, an autoimmune condition causing chronic dry eyes and mouth. Dazodalibep blocks the CD40-CD40L pathway. A second Phase 3 study in patients with high symptom burden is expected to report data in the fourth quarter, with both wins needed for regulatory approval.

EditorLim