Independent monitors pulled the plug on Argenx’s UNITY trial for Sjögren's disease after a mid-study review. The Phase 3 study, testing subcutaneous Vyvgart, failed to show enough promise to keep going. The committee’s futility verdict landed on October 8, 2026, and Argenx moved fast to halt the trial, as confirmed by a Reuters report.
Wall Street didn’t wait to react. Argenx’s American depositary receipts tumbled over 14% before the bell and closed down more than 16%. Investors had pinned hopes on the efgartigimod alfa platform, which here used Halozyme's Enhanze tech for subcutaneous delivery. The abrupt stop left a hole in Argenx’s late-stage autoimmune pipeline and rattled confidence in the company’s clinical momentum.
The UNITY trial's primary endpoint was the change from baseline in systemic disease activity at week 48, measured by the EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI), rather than just subjective symptoms or isolated laboratory markers.
UNITY trial ends with no new safety concerns
UNITY enrolled adults with moderate-to-severe Sjögren's disease, aiming to prove that efgartigimod SC could move the needle on disease activity. Argenx said the interim review turned up no new safety issues. The tolerability profile matched earlier studies. The company will run a full analysis after database lock to dig deeper into the data and guide future Sjögren's research. Still, the lack of efficacy forced Argenx to walk away from the trial.
FB102 delivers positive signal in celiac disease
On a different front, Argenx reported that its CD122 inhibitor FB102 hit the mark in a Phase 2 celiac disease study. The FB102-301 trial enrolled 126 adults and tracked the 78-day change in villus height to crypt depth ratio—a key gut tissue marker—against placebo. Fierce Biotech noted the result was statistically significant (p=0.0176). A composite marker (VCIEL) that blends histology and inflammation also backed up the main finding.
FB102’s safety profile lined up with earlier data. This marks the first clinical readout since Argenx bought Forte Biosciences for $2.2 billion in August. With UNITY off the table, Argenx now puts FB102’s next-stage development at the top of its agenda.
The interim analysis of the UNITY trial did not identify any new safety signals, and the tolerability of subcutaneous efgartigimod was consistent with its established profile. Argenx plans a full data analysis after database lock to extract further insights for future Sjögren's disease research.
UNITY’s failure leaves Argenx with fewer late-stage autoimmune shots. FB102’s celiac data now carries more weight as the company tries to keep its pipeline moving and steady investor nerves. The next steps for FB102 will shape Argenx’s position in the autoimmune drug race.
