Teva shares rise as TEV-408 meets celiac disease Phase 2a endpoint
- Teva shares rose 3.04% to $37.29 on positive Phase 2a data for TEV-408
- TEV-408 met primary endpoint for preventing gluten-induced intestinal damage
- Study showed significant reduction in inflammatory markers vs placebo
- Treatment was well-tolerated with no emerging safety signals
- Company eligible for up to $500 million from Royalty Pharma deal
*this image is generated using AI for illustrative purposes only.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) shares rose 3.04% to $37.29 after the company announced positive topline results from its ongoing Phase 2a study of TEV-408. The investigational anti-interleukin-15 monoclonal antibody met its primary endpoint for adults with celiac disease, approaching its 52-week high of $38.36.
The randomized, placebo-controlled study enrolled 50 adult participants with celiac disease on a gluten-free diet who had minimal intestinal damage at baseline, defined by a villous height-to-crypt depth ratio (Vh:Cd) of ≥2.0. Two weeks after receiving a single subcutaneous dose of TEV-408, participants began a six-week daily gluten challenge. The assessment focused on biopsy-based measures of intestinal damage and inflammation alongside patient-reported symptoms.
Clinical Endpoints and Efficacy
At week 8, the end of the gluten challenge period, TEV-408 showed statistically significant prevention of gluten-induced intestinal damage compared to placebo. The primary endpoint measured the Vh:Cd ratio, with a least squares (LS) mean change from baseline of -0.43 for TEV-408 versus -0.88 for placebo. This represented a treatment difference of 0.45 (95% CI: 0.06, 0.84; p<0.05).
The drug also demonstrated a favorable effect on intestinal inflammation. The LS mean change from baseline in the density of intraepithelial lymphocytes (IELs) was an increase of 27.60 for placebo compared to 0.37 for participants treated with TEV-408. The treatment difference was -27.23 (95% CI: -39.67, -14.79).
Additionally, the study recorded lower gastrointestinal symptom scores for TEV-408 versus placebo, as assessed using the Celiac Disease Symptom Diary (CDSD), a patient-reported outcome. The treatment was well-tolerated with no emerging safety signals observed to date.
Pipeline-in-a-Product Strategy
Teva highlighted that these results, together with its vitiligo program, support TEV-408 as a potential pipeline-in-a-product opportunity across multiple diseases. TEV-408 is also being evaluated in a Phase 1b study for vitiligo, with the company advancing the asset into a Phase 2b study following encouraging early results. By blocking IL-15 activity, the antibody aims to reduce immune-mediated destruction of melanocytes in vitiligo patients.
In January 2026, Teva entered a strategic funding agreement with Royalty Pharma. Under this deal, Teva is eligible to receive up to $500 million to accelerate the clinical development of TEV-408. If approved and launched, Teva will pay a milestone to Royalty Pharma and a royalty on worldwide net sales of TEV-408.
What the Numbers Show
The data indicates a divergence in inflammatory response between the treatment and control groups. While the placebo group saw a substantial increase in IEL density (27.60), the TEV-408 group maintained near-baseline levels (0.37). This suggests the monoclonal antibody effectively suppressed the specific immune-mediated inflammation associated with gluten exposure in this cohort, aligning with the preservation of intestinal architecture seen in the Vh:Cd ratio results.
Next Steps
Teva stated that additional analyses from the ongoing Phase 2a study are underway. The company plans to present further data from the study at a future scientific meeting. An investor call and live webcast were held on September 2, 2026, to discuss these data.
Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva, said, "A strict gluten-free diet has long been the only option for people living with celiac disease. Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage and a significant impact on their daily lives. These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source."
How might the successful Phase 2a results for celiac disease influence the timeline and design of the upcoming Phase 2b study for vitiligo?
What impact could the $500 million Royalty Pharma funding agreement have on Teva's capital allocation strategy and potential dilution risks in future financing rounds?
Given the limited sample size of 50 participants, what specific statistical power or enrollment targets will Teva need to meet in Phase 3 trials to ensure regulatory approval?
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