Belgian biotech argenx advances promising coeliac disease drug to final testing phase

2026-10-08 biotech

Ghent, Thursday 8 October 2026
Belgian biotech argenx has reported positive Phase 2 results for its coeliac disease drug candidate, FB102, which successfully prevented gluten-induced intestinal damage and will now advance to Phase 3 trials.

Clinical Trial Success of FB102 in Celiac Disease

The Ghent-headquartered immunology pioneer announced positive topline results on Thursday, 8 October 2026, marking the first clinical readout of FB102 since argenx acquired the therapeutic candidate through its acquisition of Forte Biosciences in August 2026 [1][3]. The randomized, double-blind, placebo-controlled Phase 2 trial, known as FB102-301, evaluated the first-in-class CD122 inhibitor in 126 adult patients with confirmed celiac disease who had been symptom-free on a strict gluten-free diet for at least 12 months [1]. During the clinical study, participants underwent a controlled eight-week oral gluten challenge while receiving either intravenous infusions of FB102 or a placebo [1].

Detailed Results and Phase 3 Transition

The Phase 2 trial successfully met its primary endpoint, demonstrating a statistically significant change from baseline in the ratio of villus height-to-crypt depth (Vh:Cd) at day 78 compared to the placebo group, yielding a p-value of 0.0176 [1][4]. According to KBC Securities analyst Mathijs Geerts Danau, this low p-value indicates a high probability of a real therapeutic effect, suggesting that FB102 can effectively protect the intestine from gluten-induced damage [4]. Backed by these consistent histologic, inflammatory, and clinical efficacy measures, argenx management has officially decided to advance FB102 into Phase 3 clinical development, validating the strategic acquisition of Forte Biosciences and reducing overall development risks [1][4].

A Mixed Day of Clinical Outcomes

Despite the clinical milestone achieved in celiac disease, the positive news was heavily overshadowed by a major setback in argenx’s broader pipeline [6]. The company announced the early termination of its Phase 3 UNITY trial evaluating subcutaneous efgartigimod (Vyvgart) in adults with moderate-to-severe Sjögren’s syndrome [4][5]. This decision followed a recommendation from an independent data monitoring committee (IDMC), which conducted an interim analysis of data from over 500 patients and concluded that the trial was highly unlikely to meet its primary objective [4][6]. The primary endpoint aimed to measure the change from baseline in systemic disease activity at week 48 [5][6].

Corporate Disappointment and Pipeline Impact

Luc Truyen, Chief Medical Officer at argenx, expressed deep disappointment over the UNITY trial results, particularly for patients living with Sjögren’s syndrome who are still waiting for treatments that fundamentally alter the course of their disease [5]. While efgartigimod maintained its favourable safety and tolerability profile with no new safety signals identified, the trial’s failure represents a significant commercial setback [4][6]. The UNITY study was highly anticipated as a key expansion opportunity for efgartigimod into the rheumatology space, where the drug had previously shown initial promise [6].

Market Reaction and Valuation Adjustments

The contrasting clinical updates triggered a sharp sell-off in argenx shares on Thursday, 8 October 2026 [3][6]. The company’s stock plummeted by 15.7% to trade at €707.4, dragging the share price down toward the lower half of its 52-week range of €568.4 to €925.0 [6]. This sharp decline represents a drop of -23.524% from its 52-week high. Analysts quickly adjusted their models to reflect the news [4]. KBC Securities removed the Sjögren’s syndrome indication entirely from its sum-of-the-parts valuation model, resulting in an estimated negative impact of approximately €112 per share and prompting a reduction in the price-to-earnings multiple applied to 2027 profit forecasts from 32x to 30x [4].

Sources & Ecosystem Partners

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