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TEVA's MAA for Olanzapine LAI in Schizophrenia Accepted in the EU
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Key Takeaways
Teva's MAA for olanzapine long-acting injectable (TEV-'749) in adults with schizophrenia accepted by EMA.
TEVA backed the filing with phase III SOLARIS data showing efficacy similar to oral olanzapine.
TEVA said the once-monthly injection could address the unmet need for long-acting olanzapine options.
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the European Medicines Agency (“EMA”) has accepted its marketing authorization application (“MAA”) seeking approval for olanzapine long-acting injectable (TEV-‘749) for treating adults with schizophrenia.
The filing in Europe is supported by an extensive clinical development program, including data from the phase III SOLARIS study. TEV-‘749 showed similar efficacy and safety to existing oral olanzapine products.
The olanzapine long-acting injectable (TEV-’749) is being developed as a once-monthly subcutaneous injection designed to provide the benefits of olanzapine. Olanzapine is a prescription atypical antipsychotic medication used primarily to treat schizophrenia and bipolar disorder.
Management noted that upon potential approval, TEV-‘749 could address a major unmet need in schizophrenia treatment by addressing the lack of a viable long-acting olanzapine option.
Olanzapine LAI is currently under review in the United States for treating schizophrenia in adults.
TEVA’s Price Performance
Year to date, shares of Teva have rallied 9.4% compared with the industry’s 0.3% rise.
Image Source: Zacks Investment Research
TEVA Eyes Expansion of Schizophrenia Portfolio
TEVA currently markets Uzedy extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, which was approved for the treatment of schizophrenia in the United States in 2023.
Uzedy is one of the key new branded drugs for Teva, contributing meaningfully to its revenues.
In the first quarter of 2026, Uzedy’s sales surged 62% year over year to $63 million, mainly driven by volume growth. TEVA anticipates Uzedy sales to be in the range of $250-$280 million in 2026.
A potential nod to olanzapine long-acting injectable (TEV-‘749) will help Teva diversify and address a broader schizophrenia patient population.
Besides olanzapine LAI, Teva has also made decent progress with its branded pipeline, which includes duvakitug, its anti-TL1A therapy for inflammatory bowel diseases, ulcerative colitis and Crohn’s disease.The company has partnered with Sanofi (SNY - Free Report) for duvakitug to maximize the value of the asset.
Teva and Sanofi will equally share the development costs globally. SNY is conducting phase III studies on duvakitug.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents to earnings of 11 cents. IMCR stock has lost 13.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 79.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
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TEVA's MAA for Olanzapine LAI in Schizophrenia Accepted in the EU
Key Takeaways
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the European Medicines Agency (“EMA”) has accepted its marketing authorization application (“MAA”) seeking approval for olanzapine long-acting injectable (TEV-‘749) for treating adults with schizophrenia.
The filing in Europe is supported by an extensive clinical development program, including data from the phase III SOLARIS study. TEV-‘749 showed similar efficacy and safety to existing oral olanzapine products.
The olanzapine long-acting injectable (TEV-’749) is being developed as a once-monthly subcutaneous injection designed to provide the benefits of olanzapine. Olanzapine is a prescription atypical antipsychotic medication used primarily to treat schizophrenia and bipolar disorder.
Management noted that upon potential approval, TEV-‘749 could address a major unmet need in schizophrenia treatment by addressing the lack of a viable long-acting olanzapine option.
Olanzapine LAI is currently under review in the United States for treating schizophrenia in adults.
TEVA’s Price Performance
Year to date, shares of Teva have rallied 9.4% compared with the industry’s 0.3% rise.
Image Source: Zacks Investment Research
TEVA Eyes Expansion of Schizophrenia Portfolio
TEVA currently markets Uzedy extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, which was approved for the treatment of schizophrenia in the United States in 2023.
Uzedy is one of the key new branded drugs for Teva, contributing meaningfully to its revenues.
In the first quarter of 2026, Uzedy’s sales surged 62% year over year to $63 million, mainly driven by volume growth. TEVA anticipates Uzedy sales to be in the range of $250-$280 million in 2026.
A potential nod to olanzapine long-acting injectable (TEV-‘749) will help Teva diversify and address a broader schizophrenia patient population.
Besides olanzapine LAI, Teva has also made decent progress with its branded pipeline, which includes duvakitug, its anti-TL1A therapy for inflammatory bowel diseases, ulcerative colitis and Crohn’s disease.The company has partnered with Sanofi (SNY - Free Report) for duvakitug to maximize the value of the asset.
Teva and Sanofi will equally share the development costs globally. SNY is conducting phase III studies on duvakitug.
TEVA's Zacks Rank & Stocks to Consider
Teva currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents to earnings of 11 cents. IMCR stock has lost 13.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 79.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.