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argenx Meets Primary Endpoint in Phase II Celiac Disease Study
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Key Takeaways
argenx's FB102 met the primary endpoint, significantly improving intestinal tissue measures versus placebo.
FB102 showed consistent results across inflammation, tissue damage and symptoms, with no new safety signals.
argenx plans late-stage development for FB102 and is also evaluating it for vitiligo and alopecia areata.
argenx SE (ARGX - Free Report) announced positive top-line data from a phase II study evaluating FB102, an investigational therapy in adults with celiac disease.
Celiac disease is a chronic autoimmune condition triggered by gluten, a protein found in wheat, barley and rye. The disease damages the small intestine and can cause abdominal pain, bloating, diarrhea and fatigue. Currently, a strict gluten-free diet is the standard treatment, and no medicines are approved specifically for the condition. The FDA previously granted Fast Track designation to FB102 for celiac disease.
Year to date, shares of ARGX have lost 2.7% against the industry’s 2.7% growth.
Image Source: Zacks Investment Research
ARGX’s FB102 Meets Primary Goal in Celiac Disease Study
argenx announced positive topline results from the phase II study evaluating FB102, an investigational CD122 inhibitor, in adults with celiac disease. The results mark the first clinical readout for the candidate since the company acquired Forte Biosciences in August 2026.
The study met its primary endpoint, demonstrating a statistically significant improvement in the ratio of villus height to crypt depth (Vh) at day 78 compared with placebo (p=0.0176). This measure helps assess damage to the lining of the small intestine.
Patients receiving FB102 also showed consistent improvements across other measures, including intestinal inflammation. Importantly, the treatment demonstrated a clinically relevant effect in patients undergoing a controlled gluten challenge. The safety profile was consistent with previous studies, with no new safety signals identified.
argenx plans to provide detailed data from the study at an upcoming medical conference.
Based on the positive data, argenx plans to advance FB102 into late-stage development. The company is also evaluating the candidate in other autoimmune diseases, including vitiligo and alopecia areata.
Despite the positive data readout, the stock declined nearly 12% yesterday, likely in response to another announcement made by the company on the same day. In a separate press release, argenx announced its decision to discontinue the phase III UNITY study evaluating its blockbuster therapy, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), in adults with moderate-to-severe Sjögren’s disease.
Over the past 60 days, loss per share estimates for Amarin have narrowed from 65 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents. AMRN’s shares have lost 14.1% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 62.27%.
Over the past 60 days, earnings per share estimates for Alnylam Pharmaceuticals have decreased from $8.65 to $8.63 for 2026. Over the same period, estimates for 2027 earnings per share have narrowed from $12.13 to $12.04. ALNY’s shares have plunged 43.5% year to date.
Alnylam Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 27.58%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave 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. ALDX’s shares have plunged 81.7% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
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argenx Meets Primary Endpoint in Phase II Celiac Disease Study
Key Takeaways
argenx SE (ARGX - Free Report) announced positive top-line data from a phase II study evaluating FB102, an investigational therapy in adults with celiac disease.
Celiac disease is a chronic autoimmune condition triggered by gluten, a protein found in wheat, barley and rye. The disease damages the small intestine and can cause abdominal pain, bloating, diarrhea and fatigue. Currently, a strict gluten-free diet is the standard treatment, and no medicines are approved specifically for the condition. The FDA previously granted Fast Track designation to FB102 for celiac disease.
Year to date, shares of ARGX have lost 2.7% against the industry’s 2.7% growth.
Image Source: Zacks Investment Research
ARGX’s FB102 Meets Primary Goal in Celiac Disease Study
argenx announced positive topline results from the phase II study evaluating FB102, an investigational CD122 inhibitor, in adults with celiac disease. The results mark the first clinical readout for the candidate since the company acquired Forte Biosciences in August 2026.
The study met its primary endpoint, demonstrating a statistically significant improvement in the ratio of villus height to crypt depth (Vh) at day 78 compared with placebo (p=0.0176). This measure helps assess damage to the lining of the small intestine.
Patients receiving FB102 also showed consistent improvements across other measures, including intestinal inflammation. Importantly, the treatment demonstrated a clinically relevant effect in patients undergoing a controlled gluten challenge. The safety profile was consistent with previous studies, with no new safety signals identified.
argenx plans to provide detailed data from the study at an upcoming medical conference.
Based on the positive data, argenx plans to advance FB102 into late-stage development. The company is also evaluating the candidate in other autoimmune diseases, including vitiligo and alopecia areata.
Despite the positive data readout, the stock declined nearly 12% yesterday, likely in response to another announcement made by the company on the same day. In a separate press release, argenx announced its decision to discontinue the phase III UNITY study evaluating its blockbuster therapy, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), in adults with moderate-to-severe Sjögren’s disease.
AGRX's Zacks Rank & Stocks to Consider
argenx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amarin (AMRN - Free Report) and Alnylam Pharmaceuticals (ALNY - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy) each and Aldeyra Therapeutics (ALDX - Free Report) , 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, loss per share estimates for Amarin have narrowed from 65 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents. AMRN’s shares have lost 14.1% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 62.27%.
Over the past 60 days, earnings per share estimates for Alnylam Pharmaceuticals have decreased from $8.65 to $8.63 for 2026. Over the same period, estimates for 2027 earnings per share have narrowed from $12.13 to $12.04. ALNY’s shares have plunged 43.5% year to date.
Alnylam Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 27.58%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave 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. ALDX’s shares have plunged 81.7% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.