Key Highlights
- Shares of Amgen rose approximately 4% during premarket hours Tuesday following encouraging Phase 3 data for dazodalibep in treating Sjögren’s disease
- The OASIZ 301 clinical trial achieved its primary goal, demonstrating statistically significant improvements in systemic disease severity at the 48-week mark
- Positive changes in patient outcomes emerged as soon as Week 4 and remained consistent throughout the complete 48-week trial duration
- No FDA-approved medications currently exist for Sjögren’s disease, positioning dazodalibep as a pioneering therapeutic option
- Complete trial findings will be shared at an upcoming medical conference; a companion Phase 3 trial is anticipated to conclude in the fourth quarter of 2026
Amgen (AMGN) shares climbed approximately 4% during premarket hours on Tuesday, reaching $406.02 shortly after market open, following the biotechnology company’s announcement of encouraging topline data from its Phase 3 clinical trial evaluating dazodalibep, an investigational therapy for Sjögren’s disease.
The clinical study, designated OASIZ 301, successfully achieved its primary goal. Participants demonstrated statistically significant improvements in systemic disease severity at the 48-week mark, as assessed using the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
The rally lifted AMGN shares back above their 50-day moving average threshold.
The clinical trial included approximately 621 participants diagnosed with moderate-to-severe systemic Sjögren’s disease. Data revealed meaningful improvements beginning at Week 4, with these benefits maintained throughout the entire 48-week observation period.
Sjögren’s represents a systemic autoimmune disorder characterized by dryness, persistent fatigue, chronic pain symptoms, and potential involvement of vital organs. Currently, no medications have received FDA approval specifically for this condition.
This absence of approved therapies represents a significant market opportunity. Should dazodalibep successfully navigate the regulatory approval process, it would become the inaugural FDA-sanctioned treatment option for Sjögren’s disease.
Mechanism of Action Behind Dazodalibep
Dazodalibep functions as a CD40L antagonist fusion protein. Its mechanism involves blocking the interactions among T cells, B cells, and additional immune system components that perpetuate the disease process.
Jay Bradner, Amgen’s executive vice president of research and development, noted that both the rapid onset and sustained nature of the trial outcomes strengthened the organization’s belief in the therapeutic candidate and its broader Phase 3 development program.
The trial’s most frequently reported adverse events included nasopharyngitis, urinary tract infections, elevated blood pressure, and reactions related to infusion administration. The majority of these events were classified as mild to moderate in severity. Treatment discontinuation rates attributed to adverse effects remained minimal and comparable between the active treatment arm and placebo group.
Market Competition Analysis
Amgen faces competition in this therapeutic area. Novartis (NVS) is advancing ianalumab, an alternative Sjögren’s treatment candidate that employs a distinct mechanism by targeting the BAFF protein pathway.
In clinical testing, ianalumab demonstrated improvements ranging from 1 to 1.3 points versus placebo on a 42-point symptom assessment scale. Leerink Partners analyst David Risinger anticipates regulatory approval for ianalumab within the next several months.
Risinger maintains a market perform rating on AMGN shares.
Amgen intends to share comprehensive data from the OASIZ 301 trial at a forthcoming medical conference. This detailed presentation will enable investors to better evaluate dazodalibep’s comparative profile against ianalumab.
An additional Phase 3 investigation, OASIZ 303, is evaluating dazodalibep in participants with moderate-to-severe symptomatic Sjögren’s disease. This companion study is projected to complete during the fourth quarter of 2026.
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