argenx ARGX suffered a clinical setback after deciding to discontinue the late-stage UNITY study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren’s disease.
The decision follows a recommendation from an Independent Data Monitoring Committee (“IDMC”) to stop the study for futility after an interim analysis showed that the trial was unable to meet its primary endpoint.
Shares of the company were down 12% following the announcement.
The development is a setback for argenx’s efforts to expand its immunology pipeline into Sjögren’s disease, a chronic systemic autoimmune condition characterized by symptoms such as dry eyes, dry mouth, fatigue and joint pain. The disease can significantly affect patients’ quality of life, and treatment options remain limited.
Year to date, ARGX’s shares have lost 2.7% against the industry’s 0.6% growth.
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More on ARGX’s UNITY Study
The UNITY study was a randomized, double-blind, placebo-controlled phase III trial designed to evaluate the efficacy, safety and tolerability of efgartigimod SC in adults with moderate-to-severe Sjögren’s disease.
Patients received weekly efgartigimod SC or placebo alongside stable background standard-of-care treatment. The primary endpoint was the change from baseline in systemic disease activity, measured using the clinical EULAR Sjögren’s Syndrome Disease Activity Index (clinESSDAI), at week 48.
Key secondary endpoints included the proportion of patients achieving low disease activity, response rates measured using the Sjögren’s Tool for Assessing Response (“STAR”), changes in patient-reported symptoms and safety outcomes.
However, the IDMC concluded that the study could not meet its primary endpoint, prompting ARGX to discontinue the trial.
Following the study’s closure and database lock, argenx plans to conduct a comprehensive analysis of the results to better understand the outcome and identify insights that could inform future research into Sjögren’s disease.
We note that argenx has an established commercial presence with its Vyvgart franchise. Vyvgart (efgartigimod alfa-fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor, reducing circulating IgG autoantibodies.
Vyvgart is approved for generalized myasthenia gravis (gMG), while Vyvgart Hytrulo, its subcutaneous formulation, is approved for gMG and chronic inflammatory demyelinating polyneuropathy. Vyvgart is also approved for immune thrombocytopenia in Japan.
While these approved indications provide an established foundation for the franchise, the discontinuation of the UNITY study represents a setback to its potential expansion into Sjögren’s disease. The decision limits the drug’s prospects in this indication and highlights the clinical risks associated with pipeline expansion.
The company generated $1.5 billion in global product net sales in the second quarter of 2026, representing 17% quarter-over-quarter growth and a year-over-year increase of 60% or $0.6 billion.
The news overshadowed ARGX’s announcement of positive data from another study.
ARGX announced that the phase II study evaluating FB102, a first-in-class CD122 inhibitor, in adults with celiac disease, met its primary endpoint. Patients treated with FB102 demonstrated a statistically significant and clinically relevant treatment effect compared to placebo. The company believes the results support advancing FB102 into phase III development.
ARGX Zacks Rank and Stocks to Consider
argenx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Alnylam Pharmaceuticals ALNY, currently sporting a Zacks Rank #1 (Strong Buy), and CRISPR Therapeutics CRSP and Aldeyra Therapeutics (ALDX), each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Alnylam’s 2026 earnings per share have decreased from $8.65 to $8.63. Over the same period, earnings estimates for 2027 have decreased from $12.13 to $12.04.
Alnylam’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 27.58%.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have decreased to $4.47 from $4.53. Over the same period, earnings estimates for 2027 have decreased to $3.61 from $3.63.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, with the average negative surprise being 1.38%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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This article originally published on Zacks Investment Research (zacks.com).