argenx: FB102 Phase 2 Win in Celiac, But UNITY Sjögren's Study Fails
ARGX sits 20% above its 52-week low of $661.85.
Summary
argenx announced positive Phase 2 topline results for FB102 in celiac disease (primary endpoint met, p=0.0176) and the discontinuation of the Phase 3 UNITY study of efgartigimod SC in Sjögren's disease for futility.
Updates
· Seeking Alpha — Argenx shares fell more than 14% in premarket trading after the discontinuation announcement.
Key Events · Product Development and Regulatory · ARGX
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FB102 Phase 2 Celiac Study Meets Primary Endpoint
FB102 demonstrated statistically significant improvement in villus height-to-crypt depth ratio vs placebo (p=0.0176) in 126 adults with celiac disease undergoing gluten challenge. First Phase 2 evidence that CD122 blockade prevents gluten-induced intestinal damage.
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FB102 Advances to Phase 3
argenx plans to advance FB102 into Phase 3 development for celiac disease, where no approved therapies exist. FB102 also being evaluated in vitiligo and alopecia areata.
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UNITY Phase 3 Study Discontinued for Futility
Independent Data Monitoring Committee recommended stopping the Phase 3 UNITY study of efgartigimod SC in Sjögren's disease after interim analysis showed inability to meet primary endpoint. No new safety signals identified.
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Forte Acquisition Validated
Positive FB102 results represent first clinical readout following argenx's $2.2B acquisition of Forte Biosciences completed August 27, 2026.
Analysis · ARGX · Life Sciences
argenx delivered a split clinical update. The positive Phase 2 FB102 result in celiac disease validates the $2.2B Forte Biosciences acquisition and supports advancing to Phase 3, while the UNITY futility stop removes a potential label expansion for efgartigimod SC in Sjögren's disease. The FB102 win is the more consequential event: it de-risks a major pipeline asset and opens a large market with no approved therapies. The UNITY failure is a setback but does not threaten the core VYVGART franchise.
How filings like this one have moved
In the 30 days to Oct 8, 2026, 36.4% of the 1096 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was -0.63%. These are measured outcomes after filings of this importance, not a forecast for this one.
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At the time of this filing, ARGX was trading at $791.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $59B. The 52-week trading range was $661.85 to $1,072.75. This filing was assessed with neutral market sentiment and an importance score of 8 out of 10.