Amgen Inc. (AMGN) Stock: Phase 3 Drug Success Sparks Hope for New Sjögren’s Treatment

TLDR

• Amgen (AMGN) stock falls 0.77% despite promising Phase 3 dazodalibep trial results.
• Amgen’s Phase 3 trial meets primary endpoints, offering hope for Sjögren’s patients.
• Dazodalibep significantly reduces systemic disease activity after 48 weeks of use.
• Amgen’s experimental drug improves dryness symptoms in patients with Sjögren’s.
• Amgen reports balanced serious adverse events as its Phase 3 drug program advances.

Amgen has reported positive Phase 3 results for dazodalibep, advancing efforts to develop a new Sjögren’s disease treatment. Both dosing regimens reduced systemic disease activity, while one also improved patient-reported dryness symptoms. However, Amgen (AMGN) shares declined 0.77% to $461.63, losing $3.60 despite recovering from intraday lows near $459.

Amgen Inc., AMGN

Amgen Phase 3 Trial Meets Primary Treatment Goals

Amgen announced that its OASIZ-301 trial met its primary endpoint after 48 weeks of treatment. The randomized study evaluated dazodalibep against placebo in patients with moderate to severe Sjögren’s disease. Researchers measured systemic disease activity using the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index.

The 1,500 mg regimen reduced disease activity scores by 5.6 points, compared with 3.8 points for placebo. Meanwhile, the 3,000 mg regimen achieved a 5.2-point reduction over the same period. Both regimens demonstrated statistically significant improvements, supporting dazodalibep’s potential as a new treatment option.

Additionally, researchers observed treatment benefits as early as Week 4, with improvements continuing through Week 48. The company will present detailed findings during the American College of Rheumatology Convergence 2026 meeting. These results expand on the positive preliminary findings Amgen announced in September.

Dazodalibep Improves Dryness and Systemic Symptoms

The trial also demonstrated improvements in dryness symptoms among patients receiving 1,500 mg every four weeks. Researchers recorded significant differences between dazodalibep and placebo using two established patient-reported symptom assessments. Moreover, participants receiving treatment showed greater improvements in stimulated salivary flow, an objective measure of oral dryness.

Further analyses showed that more treated patients achieved meaningful reductions in systemic disease activity than placebo recipients. Both dosing regimens also improved overall patient-reported symptom scores throughout the 48-week study. Additionally, researchers identified benefits across several disease areas, including glandular, joint, skin, and biological manifestations.

Sjögren’s disease affects moisture-producing glands and can also cause fatigue, joint pain, and organ complications. Currently, the United States has no FDA-approved treatments specifically for the disease. Therefore, successful clinical development could provide another treatment approach for patients with persistent symptoms.

Amgen Reports Safety Findings as Development Continues

Amgen reported that most common adverse events involved infections, hypertension, and infusion-related reactions. These events generally showed mild to moderate severity across the treatment groups. Meanwhile, serious adverse events and treatment discontinuations occurred at comparable rates across the three groups.

Researchers also found no imbalance in thromboembolic events or opportunistic infections between treatment groups. Malignancy rates remained low and comparable, adding further information to the drug’s safety profile. However, dazodalibep still requires further clinical development and regulatory review before potential commercial approval.

The Phase 3 results strengthen Amgen’s development program for a disease with limited treatment options. The company plans to advance broader Phase 3 research while evaluating additional clinical outcomes. Its latest findings provide evidence supporting continued development of dazodalibep for Sjögren’s disease.

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