argenx discontinued the Phase 3 UNITY study of subcutaneous efgartigimod in moderate-to-severe Sjögren's disease after an interim futility review. An independent data monitoring committee concluded that the trial could not meet its primary endpoint, a change in systemic disease activity at week 48.
The decision is a failure of efficacy, not a new safety finding. argenx said safety remained consistent with efgartigimod's established profile and that no new signals emerged. The distinction matters because it removes one potential expansion opportunity without directly undermining approved Vyvgart uses in other autoimmune diseases.
Why the result surprised investors
UNITY data had been expected in the second half of 2027. The early stop arrived after earlier Phase 2 results had shown a larger reduction in disease activity with efgartigimod than with placebo. Shares fell nearly 15% on the day reported by the source, reflecting the abrupt loss of a pipeline option and the gap between encouraging early data and a failed registrational study.
The trial targeted a difficult and heterogeneous disease. Sjögren's can affect glands and multiple organ systems, which makes a single composite endpoint challenging. That context explains uncertainty but does not change the committee's conclusion that the Phase 3 study was unable to meet its primary endpoint.
A separate program moved forward
On the same date, argenx reported that FB102 met the primary endpoint in a 126-patient Phase 2 celiac-disease study. The trial measured the ratio of villus height to crypt depth after a gluten challenge and produced a p-value of 0.0176 versus placebo. argenx acquired FB102 through its approximately $2.2 billion purchase of Forte Biosciences and plans to advance the drug into Phase 3.
The positive celiac result provides counterevidence to a uniformly negative pipeline reading, but it is not yet a substitute for a successful late-stage program. Full efficacy and safety data, the Phase 3 design and development spending will determine how much value FB102 can recover.
For investors, UNITY should be removed from near-term probability-weighted value rather than treated as a temporary delay. The next measurable developments are detailed FB102 data and other late-stage Vyvgart readouts. Those results will show whether argenx's broader pipeline can offset the lost Sjögren's opportunity.