By Gwendolyn Wu | September 22, 2026
In a significant advancement for the treatment of autoimmune disorders, Amgen announced on Tuesday that its experimental drug, dazodalibep, has successfully met its primary endpoints in the first of two pivotal late-stage clinical trials. The drug, which was inherited by the biopharmaceutical giant through its massive $27.8 billion acquisition of Horizon Therapeutics, is being evaluated for its potential to alter the course of Sjögren’s disease, a chronic and debilitating condition that has historically eluded effective pharmacological intervention.
The positive topline results represent a critical turning point for the therapy, which has navigated a complex corporate history to reach its current position as a centerpiece of Amgen’s immunology pipeline. As the company prepares for a second pivotal data readout later this year, the industry is closely watching to see if dazodalibep can secure a foothold in a competitive landscape currently dominated by a lack of disease-modifying therapies.
The Challenge of Sjögren’s: A Historical Clinical Barrier
Sjögren’s disease remains one of the most challenging targets in modern immunology. Characterized by a systemic attack where the immune system destroys the body’s moisture-producing glands, the disorder leads to severe, chronic dry eyes and mouth, debilitating joint pain, systemic inflammation, and profound fatigue. Beyond these symptoms, patients face a significantly elevated risk of developing lymphoma, a form of blood cancer.
For decades, the standard of care for Sjögren’s has been limited to palliative measures—treatments that mask symptoms rather than addressing the underlying pathology. There are currently no FDA-approved therapies capable of modifying the disease’s progression. Because of this, the medical community has long sought a "holy grail" treatment that can stabilize the immune system and prevent the long-term tissue damage that defines the syndrome.
Mechanism of Action: Disrupting the CD40-CD40L Pathway
The scientific promise of dazodalibep lies in its specific design as a modulator of the immune system’s communication network. The drug is engineered to target and block the CD40-CD40L pathway, a critical signaling conduit between immune cells.
By obstructing this pathway, dazodalibep is designed to blunt the hyperactive immune response that triggers the formation of autoantibodies—the proteins that mistakenly attack the body’s own healthy tissue. By suppressing this cellular crosstalk, the drug aims to reduce systemic inflammation and prevent the progressive destruction of glandular tissue. Earlier Phase 2 data provided the proof-of-concept, showing that participants experienced a meaningful reduction in both patient-reported symptoms and objective markers of disease activity, setting the stage for the current, more rigorous Phase 3 evaluation.
A Complex Corporate Odyssey: From AstraZeneca to Amgen
The trajectory of dazodalibep is as complex as the biological pathway it seeks to inhibit. The molecule was originally discovered by AstraZeneca, which subsequently spun it off into an independent startup, Viela Bio. Viela’s focus on autoimmune conditions caught the attention of Horizon Therapeutics, which acquired the company in 2021 to bolster its rare disease portfolio.
The final chapter of this corporate journey occurred in 2023, when Amgen finalized its acquisition of Horizon Therapeutics, an $27.8 billion deal that was heavily scrutinized by the Federal Trade Commission. By absorbing Horizon, Amgen inherited a broad array of promising assets, with dazodalibep quickly rising to the top of the list as a potential blockbuster in the immunology space. The success in this first Phase 3 trial serves as early validation of the investment, justifying the integration of the Horizon pipeline into Amgen’s broader strategic objectives.
Official Responses and Clinical Perspectives
The lead investigator for the study, Ghaith Noaiseh, a professor of immunology at the University of Kansas Medical Center, hailed the results as a major step forward. "These topline results provide further support for dazodalibep as an emerging treatment for improving systemic disease activity and represent an important advance for the field," Noaiseh stated.
Amgen executives have remained cautious but optimistic, emphasizing that the data confirms the drug’s mechanism of action is consistent across different clinical settings. The company has noted that the full data set will be presented at an upcoming medical congress, where experts will be able to evaluate the drug’s safety profile and the magnitude of its clinical impact against existing benchmarks.
The Competitive Landscape: A Three-Way Race
While Amgen celebrates this victory, the market for Sjögren’s therapies is heating up. Amgen is not the only player with a horse in this race; several major pharmaceutical firms are racing to be the first to gain regulatory approval for a disease-modifying Sjögren’s treatment.
Novartis is currently seen as the most immediate competitor, with its experimental therapy, ianalumab. Industry observers suggest that ianalumab could potentially be cleared by regulators as early as the current quarter. Meanwhile, Bristol Myers Squibb is also in the fray, currently testing its marketed psoriasis drug, Sotyktu, in a Phase 3 study for Sjögren’s.
Analysts at Leerink Partners, led by David Risinger, suggest that the specific data Amgen releases in the coming months will be the deciding factor in how the drug is positioned against the Novartis offering. "The study specifics Amgen eventually presents will help inform positioning against ianalumab," Risinger wrote in a note to clients. Interestingly, the market has expressed skepticism regarding the Bristol Myers Squibb trial, with analysts noting "very low expectations" for the outcome of that particular study.
Implications for Amgen’s Future Pipeline
For Amgen, the stakes extend beyond the immediate revenue potential of a single drug. Success with dazodalibep would solidify the company’s pivot toward high-value, specialized immunology, a sector that offers higher margins and longer patent protections than traditional small-molecule drugs.
However, analysts remain grounded in the reality of clinical development. William Blair analyst Matt Phipps noted that while he was "encouraged" by the announcement—especially given that his firm had previously viewed the program as a "relatively high-risk" endeavor—the path to market remains fraught with hurdles.
"Amgen’s two Phase 3 trials involve distinct patient populations," Phipps cautioned. "The company will need to secure victories in both studies to satisfy regulators and win final approval."
Looking Ahead: The Fourth Quarter and Beyond
The next major milestone for the program is the data readout from the second Phase 3 study, which focuses on patients with a "high symptom burden." This group represents the most critical demographic—those whose quality of life is most severely impacted by the disease. Data from this second trial is expected in the fourth quarter of 2026.
Should the second trial yield positive results, Amgen will likely move to file a Biologics License Application (BLA) with the FDA. If successful, dazodalibep would not only represent a significant financial win for the company but would fundamentally transform the standard of care for millions of patients living with the daily pain and uncertainty of Sjögren’s disease.
As the industry waits for the final data, the message from the recent announcement is clear: after years of being a "tricky target," Sjögren’s is finally seeing the kind of rigorous, large-scale clinical attention that has long been overdue. For Amgen, the success of dazodalibep is the first step in proving that its acquisition strategy was not just about scale, but about capturing the next generation of life-altering medical breakthroughs.
About the Author
