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Amgen’s Horizon-acquired fusion protein eases Sjögren's severity in ph. 3 win

Amgen announced positive topline Phase 3 results for dazodalibep, a fusion protein used to treat moderate-to-severe systemic Sjögren's disease. The drug succeeded in its late-stage trial by easing the severity of the autoimmune condition. Following the announcement, Amgen shares rallied 4.3%. The fusion protein was acquired through Amgen's purchase of Horizon.

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⚡ Key Developments & Real-Time Context
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  • ✓ Dazodalibep achieved positive topline Phase 3 results for the treatment of moderate-to-severe systemic Sjögren's disease.
  • ✓ The drug is a fusion protein that Amgen acquired via Horizon.
  • ✓ Amgen shares rose 4.3% following the trial results.
🛡️ Source Corroboration: 7 independent reporting domains (100% confidence) ⏱ Read time: ~2 min

What changed

Amgen released Phase 3 topline data confirming the efficacy of dazodalibep for systemic Sjögren's disease.

Live updates

  1. Amgen reports positive Phase 3 results for Sjögren's drug dazodalibep

    Amgen announced positive topline Phase 3 results for dazodalibep, a fusion protein used to treat moderate-to-severe systemic Sjögren's disease. The drug succeeded in its late-stage trial by easing the severity of the autoimmune condition. Following the announcement, Amgen shares rallied 4.3%. The fusion protein was acquired through Amgen's purchase of Horizon.

    Why it matters

    Sjögren's disease is a systemic autoimmune condition that often causes dry eyes and mouth. This trial represents a late-stage effort to provide a targeted therapy for patients with moderate-to-severe symptoms.

    What is confirmed

    • Dazodalibep achieved positive topline Phase 3 results for the treatment of moderate-to-severe systemic Sjögren's disease.
    • The drug is a fusion protein that Amgen acquired via Horizon.
    • Amgen shares rose 4.3% following the trial results.

    What to watch next

    • FDA filing or approval timeline for dazodalibep
    • Detailed efficacy and safety data from the Phase 3 trial
    Sources used for this update (6)
    1. Fierce Biotech — Amgen’s Horizon-acquired fusion protein eases Sjögren's severity in ph. 3 win
    2. Reuters — Amgen's autoimmune drug succeeds in late-stage trial
    3. Endpoints News — Amgen’s Phase 3 Sjögren’s win; Novartis’ $900M radioligand deal
    4. PR Newswire — AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR DAZODALIBEP IN MODERATE-TO-SEVERE SYSTEMIC SJÖGREN'S DISEASE
    5. Investor's Business Daily — Amgen Boasts Success In Sjogren's; Shares Bound Higher
    6. GuruFocus — Is Amgen Inc (AMGN) Overvalued After 4.3% Rally? GF Value Says O
    confidence 100%
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