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TEVA's TEV '408 Meets Goal in Phase IIa Celiac Disease Study
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Key Takeaways
Teva's TEV '408 met the primary endpoint in a phase IIa study in adults with celiac disease.
TEV '408 reduced gluten-induced intestinal damage, inflammation and gastrointestinal symptoms versus placebo.
TEV '408's celiac and vitiligo programs support its potential as a pipeline-in-a-product opportunity.
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the phase IIa study, which evaluated its investigational anti-interleukin-15 monoclonal antibody, TEV ‘408, in adult patients with celiac disease, has met its primary endpoint.
Data from the study showed that treatment with a single subcutaneous dose of TEV ‘408 led to a statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8.
TEV ‘408 showed a favorable effect on intestinal inflammation and lower gastrointestinal symptom scores versus placebo. Treatment with TEV ‘408 was also generally well-tolerated, with no safety signals reported to date.
The randomized, placebo-controlled phase IIa study enrolled 50 adult patients with celiac disease who were following a gluten-free diet. Teva said additional analyses from the study are currently underway and plans to present further data at a future medical conference.
Currently, there are no approved therapies for treating celiac disease.
TEVA’s Price Performance
Year to date, shares of Teva have rallied 20.1% compared with the industry’s increase of 6.1%.
Image Source: Zacks Investment Research
More on TEVA’s Development Activities With TEV ‘408
Besides celiac disease, TEV-'408 is also being developed for vitiligo.
In July 2026, Teva announced plans to advance its investigational anti-IL-15 antibody TEV-'408 into a phase IIb study for vitiligo in the fourth quarter of 2026 following encouraging phase Ib results.
Designed for once-every-12-week subcutaneous dosing, TEV-'408 targets the IL-15 pathway, a key driver of vitiligo biology, and could provide a convenient treatment option for patients with limited therapeutic alternatives.
Per management, the above-mentioned celiac disease results, together with its vitiligo program, further support TEV ‘408’s potential as a pipeline-in-a-product opportunity in multiple diseases.
Teva also has several key branded pipeline assets in neuroscience and immunology, which it believes represent a multi-billion-dollar commercial opportunity. These include olanzapine LAI, a long-acting subcutaneous injectable for schizophrenia, and ecopipam, which was acquired through Emalex Biosciences and is being developed for pediatric Tourette syndrome. Both candidates are under U.S. regulatory review, with Teva targeting potential launches of olanzapine LAI in the fourth quarter of 2026 and ecopipam in the first half of 2027, subject to approval.
Another key pipeline asset is duvakitug, a late-stage anti-TL1A therapy being developed for inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. Teva believes duvakitug also has pipeline-in-a-product potential.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 5.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share, while estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 124.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents, while estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 67.5% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
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TEVA's TEV '408 Meets Goal in Phase IIa Celiac Disease Study
Key Takeaways
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the phase IIa study, which evaluated its investigational anti-interleukin-15 monoclonal antibody, TEV ‘408, in adult patients with celiac disease, has met its primary endpoint.
Data from the study showed that treatment with a single subcutaneous dose of TEV ‘408 led to a statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8.
TEV ‘408 showed a favorable effect on intestinal inflammation and lower gastrointestinal symptom scores versus placebo. Treatment with TEV ‘408 was also generally well-tolerated, with no safety signals reported to date.
The randomized, placebo-controlled phase IIa study enrolled 50 adult patients with celiac disease who were following a gluten-free diet. Teva said additional analyses from the study are currently underway and plans to present further data at a future medical conference.
Currently, there are no approved therapies for treating celiac disease.
TEVA’s Price Performance
Year to date, shares of Teva have rallied 20.1% compared with the industry’s increase of 6.1%.
Image Source: Zacks Investment Research
More on TEVA’s Development Activities With TEV ‘408
Besides celiac disease, TEV-'408 is also being developed for vitiligo.
In July 2026, Teva announced plans to advance its investigational anti-IL-15 antibody TEV-'408 into a phase IIb study for vitiligo in the fourth quarter of 2026 following encouraging phase Ib results.
Designed for once-every-12-week subcutaneous dosing, TEV-'408 targets the IL-15 pathway, a key driver of vitiligo biology, and could provide a convenient treatment option for patients with limited therapeutic alternatives.
Per management, the above-mentioned celiac disease results, together with its vitiligo program, further support TEV ‘408’s potential as a pipeline-in-a-product opportunity in multiple diseases.
Teva also has several key branded pipeline assets in neuroscience and immunology, which it believes represent a multi-billion-dollar commercial opportunity. These include olanzapine LAI, a long-acting subcutaneous injectable for schizophrenia, and ecopipam, which was acquired through Emalex Biosciences and is being developed for pediatric Tourette syndrome. Both candidates are under U.S. regulatory review, with Teva targeting potential launches of olanzapine LAI in the fourth quarter of 2026 and ecopipam in the first half of 2027, subject to approval.
Another key pipeline asset is duvakitug, a late-stage anti-TL1A therapy being developed for inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. Teva believes duvakitug also has pipeline-in-a-product potential.
TEVA's Zacks Rank & Stocks to Consider
Teva currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 5.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share, while estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 124.3% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents, while estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 67.5% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.