Amgen’s Horizon-acquired fusion protein eases Sjögren's severity in ph. 3 win
Amgen announced positive Phase 3 results on September 22, 2026, for a treatment targeting Sjögren's disease. The success led Cantor to raise its Amgen stock target to USD 440.00. This clinical win follows a period of financial growth for the company, with Q2 revenue increasing 9.50 percent to USD 10.05 billion. As of October 15, 2026, Amgen stock traded at EUR 385.38, reflecting a 0.57 percent increase over the Xetra close.
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- ✓ Amgen announced positive phase 3 results for Sjögren's on September 22, 2026.
- ✓ Amgen Q2 revenue rose 9.50 percent to USD 10.05 billion.
- ✓ Amgen stock was EUR 385.38 on October 15, 2026.
What changed
Amgen reported a Phase 3 win for its Sjögren's treatment on September 22, 2026.
Live updates
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Amgen reports positive Phase 3 results for Sjögren's treatment
Amgen announced positive Phase 3 results on September 22, 2026, for a treatment targeting Sjögren's disease. The success led Cantor to raise its Amgen stock target to USD 440.00. This clinical win follows a period of financial growth for the company, with Q2 revenue increasing 9.50 percent to USD 10.05 billion. As of October 15, 2026, Amgen stock traded at EUR 385.38, reflecting a 0.57 percent increase over the Xetra close.
Why it matters
The development arrives as other companies struggle with similar goals. Argenx SE recently stopped its Phase 3 UNITY study for subcutaneous efgartigimod due to futility. These results indicate a potential path forward for treating moderate-to-severe Sjögren's disease.
What is confirmed
- Amgen announced positive phase 3 results for Sjögren's on September 22, 2026.
- Amgen Q2 revenue rose 9.50 percent to USD 10.05 billion.
- Amgen stock was EUR 385.38 on October 15, 2026.
What to watch next
- FDA approval status and PDUFA dates for the fusion protein
- Detailed clinical data regarding the reduction of disease severity
confidence 100%Sources used for this update (5)
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- www.marketbeat.com — Amgen (AMGN) FDA Approvals, PDUFA Dates & Drug Alerts 2026
- www.ad-hoc-news.de — Amgen announces phase 3 Sjögren's results: what it means for ...
- www.ad-hoc-news.de — Amgen reports Sjogren Phase 3 win. Cantor lifts Amgen stock ...
- www.sjogrensadvocate.com — New Sjogren’s Treatments: Who Will Benefit?
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Argenx Discontinues Phase 3 Sjogren's Disease Trial
Argenx SE is discontinuing its Phase 3 UNITY study evaluating subcutaneous efgartigimod in adults with moderate-to-severe Sjogren's disease. The decision follows an interim analysis where an Independent Data Monitoring Committee recommended stopping the trial for futility because it was unable to meet its primary endpoint. Safety findings remained consistent with the established profile of the drug, and no new safety signals appeared during the evaluation. Meanwhile, separate open-label extension data indicates that long-term intravenous efgartimod therapy maintains a safe profile for adults suffering from the condition.
Why it matters
The discontinuation marks a setback for pipeline therapies targeting Sjogren's disease, an autoimmune condition historically lacking approved treatments. Amgen previously advanced its own pipeline with positive Phase 3 results for dazodalibep, a fusion protein secured through its acquisition of Horizon Therapeutics. While other treatments like intravenous efgartimod show stable safety profiles in extended settings, the failure of the subcutaneous UNITY study highlights the difficulties of meeting primary clinical endpoints in this therapeutic space.
What is confirmed
- Argenx SE announced it will discontinue the Phase 3 UNITY study of efgartigimod subcutaneous in adults with moderate-to-severe Sjogren's disease.
- An Independent Data Monitoring Committee recommended stopping the study for futility after concluding it is unable to meet its primary endpoint.
- Safety was consistent with the established profile of efgartigimod and no new safety signals were identified in the trial.
- Long-term intravenous efgartimod therapy is safe in adults with Sjogren disease based on open-label extension findings.
What to watch next
- Detailed efficacy and safety data releases from the discontinued UNITY study
- Further clinical updates regarding intravenous efgartimod in Sjogren's disease
confidence 100%Sources used for this update (4)
- www.marketscreener.com — Amgen Inc.: Official Announcements - Stock Market News
- www.rheumatologyadvisor.com — Efgartimod Maintains Safety Profile in Open-Label Extension ...
- crweworld.com — argenx Provides Update on Phase 3 UNITY Study of Efgartigimod ...
- www.compuserve.com — argenx Provides Update on Phase 3 UNITY Study of Efgartigimod ...
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Amgen’s Dazodalibep Scores Phase 3 Win in Sjögren's Disease
Amgen announced positive topline results from the Phase 3 OASIZ 301 trial evaluating dazodalibep in systemic Sjögren's disease. The fusion protein, obtained through the $27.8 billion acquisition of Horizon Therapeutics, successfully targets an autoimmune condition that currently lacks approved treatments. The trial success has driven renewed market attention toward Amgen and strengthened its broader immunology pipeline. Share performance shows strong multi-month gains alongside the pipeline advancement, as researchers and clinicians review evolving treatment approaches for the systemic autoimmune disorder.
Why it matters
Sjögren's disease is a chronic autoimmune condition characterized by high costs and diagnostic delays for patients. The successful trial positions dazodalibep among targeted pipeline therapies advancing toward potential regulatory review. This outcome highlights the early payoff from Amgen's major corporate acquisition strategy within the autoimmune disease space.
What is confirmed
- Amgen reported positive topline Phase 3 data from the OASIZ 301 trial of dazodalibep in Sjögren's disease.
- Dazodalibep is a fusion protein that blocks immune cell crosstalk and was acquired through Amgen's purchase of Horizon Therapeutics.
- Amgen's acquisition of Horizon Therapeutics was valued at $27.8 billion.
Still unconfirmed
- The acquisition cost was separately cited in market commentary as a $28 billion transaction.
What to watch next
- Detailed efficacy and safety data releases from the OASIZ 301 trial
- Subsequent regulatory filing timelines for dazodalibep
confidence 95%Sources used for this update (7)
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- rheumnow.com — Sjogrens - RheumNow
- guavy.com — Amgen's Dazodalibep Wins Phase 3 Trial in Unserved Sjögren's ...
- finance.yahoo.com — Amgen (AMGN), What Is Behind The Fresh Attention?
- biotechmorning.com — Amgen's $28 Billion Bet on Horizon Just Got a Whole Lot ...
- simplywall.st — Is Amgen (AMGN) Undervalued Following Its Phase 3 Sjögren's ...
- www.ajmc.com — Pipeline Advances in Sjögren Disease Bring Targeted Therapies ...
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Amgen's dazodalibep eases Sjögren's severity in Phase 3 trial
Amgen's dazodalibep, a fusion protein acquired through its purchase of Horizon, succeeded in a Phase 3 trial for moderate-to-severe systemic Sjögren's disease, demonstrating a statistically significant improvement in systemic disease activity. The drug met the primary endpoint, easing disease severity. Amgen shares rallied 4.3% following the announcement.
Why it matters
Sjögren's disease is a chronic autoimmune condition with limited treatment options. The trial's success provides Amgen with a potential new growth opportunity. Dazodalibep's mechanism of action and efficacy could help address the unmet needs of patients with Sjögren's disease.
What is confirmed
- Dazodalibep met the primary endpoint in a Phase 3 study, demonstrating a statistically significant improvement in systemic disease activity in people with moderate-to-severe systemic Sjögren's disease.
- Amgen shares rallied 4.3% following the announcement of positive topline Phase 3 results for dazodalibep.
- The fusion protein dazodalibep was acquired through Amgen's purchase of Horizon.
What to watch next
- Future regulatory decisions on dazodalibep's approval
- Details on the drug's safety profile and side effects
- Potential market launch and pricing strategy for dazodalibep
confidence 85%Sources used for this update (5)
- www.finanznachrichten.de — AMGEN INC CDR
- www.europeanpharmaceuticalreview.com — Amgen reports positive topline Phase 3 Sjögren’s results
- www.chemdiv.com — First of Amgen’s Phase III Sjögren’s disease trials succeeds ...
- guavy.com — Amgen's Dazodalibep Scores Big Win in Sjogren's Study
- el7.ai — Amgen Reports Positive Phase 3 Results for… | EL7.AI
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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
confidence 100%Sources used for this update (6)
- Fierce Biotech — Amgen’s Horizon-acquired fusion protein eases Sjögren's severity in ph. 3 win
- Reuters — Amgen's autoimmune drug succeeds in late-stage trial
- Endpoints News — Amgen’s Phase 3 Sjögren’s win; Novartis’ $900M radioligand deal
- PR Newswire — AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR DAZODALIBEP IN MODERATE-TO-SEVERE SYSTEMIC SJÖGREN'S DISEASE
- Investor's Business Daily — Amgen Boasts Success In Sjogren's; Shares Bound Higher
- GuruFocus — Is Amgen Inc (AMGN) Overvalued After 4.3% Rally? GF Value Says O
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