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Novel Sjogren's Drug Passes First Phase III Test

Published

12 November 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at medpagetoday.com →

◆ Verified

Fusion42 · 12 November 2026 · Fusion42 review

Amgen's investigational CD40L antagonist dazodalibep demonstrated statistically significant efficacy and safety in a 48-week phase III trial for Sjögren's disease, showing clinically meaningful reductions in disease activity scores compared to placebo. The drug, a fusion protein distinct from monoclonal antibodies, is on track for likely approval pending completion of a second phase III trial.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

Your biotech company needs to prepare for competition now that a new Sjögren's drug clears its first clinical approval hurdle with strong efficacy and safety. This shifts investment and partnership opportunities in autoimmune treatments as Amgen shows fusion proteins can succeed beyond antibodies.

◆ Coverage

1 source · 12 Nov 2026

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◆ Topics

Biotechsjogrens-diseasephase-iiiclinical-trialsamgencd40l-antagonistdrug-approval