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TEVA Files NDA With FDA for Olanzapine LAI for Schizophrenia
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Key Takeaways
TEVA filed an NDA seeking FDA approval for olanzapine LAI in adults with schizophrenia.
The NDA includes phase III SOLARIS data plus week 56 results on efficacy, safety and tolerability.
A potential approval would broaden TEVA's schizophrenia franchise and support long-term revenue goals.
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval for olanzapine, a long-acting subcutaneous injectable (LAI) for treating adults with schizophrenia.
The NDA is supported by data from the phase III SOLARIS study, which evaluated olanzapine extended-release injectable suspension for the treatment of schizophrenia in adults. The filing also included week 56 data studying olanzapine LAI’s efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.
Olanzapine is a prescription atypical antipsychotic medication used primarily to treat schizophrenia and bipolar disorder.
If approved, olanzapine LAI has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation while addressing a critical treatment gap for people living with schizophrenia.
In the SOLARIS study, olanzapine LAI showed similar efficacy and safety to existing oral olanzapine products.
TEVA’s Price Performance
Year to date, shares of Teva have rallied 29.6% compared with the industry’s 27.9% rise.
Image Source: Zacks Investment Research
FDA Nod Could Broaden Teva’s 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 the company’s revenues.
In the first nine months of 2025, Uzedy’s sales surged 82% year over year to $136 million, with total sales expected to be between $190 million and $200 million in 2025.
A potential FDA nod to olanzapine LAI will help Teva diversify and address a broader schizophrenia patient population. The company expects its long-acting franchise in schizophrenia, comprising Uzedy and olanzapine LAI, to generate $1.5- $2.0 billion in peak sales.
TEVA’s New Branded Drugs Aid Top-Line Growth
Teva has been witnessing continued market share growth of its newest branded drugs, including Uzedy, Austedo and Ajovy.
Austedo sales rose 33% in the first nine months of 2025. Teva expects Austedo annual revenues to be more than $2.5 billion by 2027 and exceed $3 billion by 2030. Ajovy sales rose 27% in the first nine months of 2025.
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 (UC) and Crohn’s disease (CD).
Teva 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. Sanofi recently initiated phase III studies on duvakitug for both UC and CD indications.
Teva anticipates generating more than $5 billion in revenues from its branded products by 2030.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. EPS estimates for 2026 have moved up from $7.79 to $8.15 during the same period. ANIP stock has surged 47.8% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 65 cents to 23 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $2.10 to $1.42. Year to date, shares of CSTL have rallied 43.6%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.
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TEVA Files NDA With FDA for Olanzapine LAI for Schizophrenia
Key Takeaways
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval for olanzapine, a long-acting subcutaneous injectable (LAI) for treating adults with schizophrenia.
The NDA is supported by data from the phase III SOLARIS study, which evaluated olanzapine extended-release injectable suspension for the treatment of schizophrenia in adults. The filing also included week 56 data studying olanzapine LAI’s efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.
Olanzapine is a prescription atypical antipsychotic medication used primarily to treat schizophrenia and bipolar disorder.
If approved, olanzapine LAI has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation while addressing a critical treatment gap for people living with schizophrenia.
In the SOLARIS study, olanzapine LAI showed similar efficacy and safety to existing oral olanzapine products.
TEVA’s Price Performance
Year to date, shares of Teva have rallied 29.6% compared with the industry’s 27.9% rise.
Image Source: Zacks Investment Research
FDA Nod Could Broaden Teva’s 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 the company’s revenues.
In the first nine months of 2025, Uzedy’s sales surged 82% year over year to $136 million, with total sales expected to be between $190 million and $200 million in 2025.
A potential FDA nod to olanzapine LAI will help Teva diversify and address a broader schizophrenia patient population. The company expects its long-acting franchise in schizophrenia, comprising Uzedy and olanzapine LAI, to generate $1.5- $2.0 billion in peak sales.
TEVA’s New Branded Drugs Aid Top-Line Growth
Teva has been witnessing continued market share growth of its newest branded drugs, including Uzedy, Austedo and Ajovy.
Austedo sales rose 33% in the first nine months of 2025. Teva expects Austedo annual revenues to be more than $2.5 billion by 2027 and exceed $3 billion by 2030. Ajovy sales rose 27% in the first nine months of 2025.
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 (UC) and Crohn’s disease (CD).
Teva 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. Sanofi recently initiated phase III studies on duvakitug for both UC and CD indications.
Teva anticipates generating more than $5 billion in revenues from its branded products by 2030.
TEVA's Zacks Rank & Stocks to Consider
Teva currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. EPS estimates for 2026 have moved up from $7.79 to $8.15 during the same period. ANIP stock has surged 47.8% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 65 cents to 23 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $2.10 to $1.42. Year to date, shares of CSTL have rallied 43.6%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.