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TEVA Gets FDA Nod for Weltruza as Once-Monthly LAI in Schizophrenia
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Key Takeaways
Teva's Weltruza gets FDA nod as the first once-monthly subcutaneous olanzapine LAI for schizophrenia in adults
Weltruza offers three dosage strengths without loading doses, oral supplementation or post-injection check.
Weltruza's weight gain and metabolic changes align with oral olanzapine's known safety profile.
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the FDA has approved Weltruza (olanzapine) extended-release injectable suspension for the treatment of schizophrenia in adults.
Following the nod, Weltruza became the first and only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine approved for adults with schizophrenia.
Shares of Teva were up 4.7% following the announcement on Oct. 9.
Weltruza will be launched in the United States in the coming weeks. The product will be available in three dosage strengths — 318 mg, 425 mg and 531 mg — corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively. Per management, the treatment requires no loading doses, oral supplementation or post-injection monitoring.
Weltruza offers an alternative to daily oral olanzapine, a widely prescribed atypical antipsychotic for schizophrenia. Weltruza is designed to help address treatment adherence challenges associated with daily medications by providing a once-monthly injection.
TEVA Price Performance
Year to date, shares of Teva have rallied 31.7% compared with the industry’s 9.2% rise.
Image Source: Zacks Investment Research
More on TEVA’s Weltruza FDA Nod
The latest FDA approval for Weltruza was based on results from the pivotal phase III SOLARIS study, which demonstrated improvements in schizophrenia symptoms, significant reduction in illness severity, and improvement in personal and social functioning.
The three Weltruza doses showed similar tolerability profiles. The most common adverse events included weight gain, somnolence, headache, constipation and injection-site reactions. Weight gain and metabolic changes were consistent with the known safety profile of oral olanzapine.
In December 2025, Teva submitted the new drug application (NDA) to the FDA seeking approval for Weltruza for treating adults with schizophrenia.
Teva’s marketing authorization application, seeking approval for olanzapine long-acting injectable (TEV-‘749) for treating adults with schizophrenia, is currently under review in Europe.
TEVA Seeks 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 six months of 2026, Uzedy’s sales surged 51% year over year to $140 million, mainly driven by volume growth. TEVA anticipates Uzedy sales to be in the range of $270-$290 million in 2026.
Management believes Uzedy has substantial long-term potential because long-acting injectable antipsychotics are increasingly being adopted in psychiatric care.
Also, the FDA nod to Weltruza should help Teva diversify and address a broader schizophrenia patient population.
Meanwhile, 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 (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.
Teva plans to begin other studies for duvakitug in two additional indications — hidradenitis suppurativa and fibrostenotic CD. The company believes duvakitug has pipeline-in-a-product potential.
Over the past 60 days, estimates for Actuate Therapeutics’ 2026 loss per share have narrowed from 86 cents to 73 cents, while loss per share estimates for 2027 have declined from 78 cents to 59 cents during the same time. ACTU’s shares have plunged 90% year to date.
Actuate Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 8.21%.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have narrowed from $4.53 to $4.47, while loss per share estimates for 2027 have declined from $3.63 to $3.61 during the same time. CRSP’s shares have risen 1.9% year to date.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average negative surprise being 1.38%.
View the Zacks #1 Rank List
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TEVA Gets FDA Nod for Weltruza as Once-Monthly LAI in Schizophrenia
Key Takeaways
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that the FDA has approved Weltruza (olanzapine) extended-release injectable suspension for the treatment of schizophrenia in adults.
Following the nod, Weltruza became the first and only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine approved for adults with schizophrenia.
Shares of Teva were up 4.7% following the announcement on Oct. 9.
Weltruza will be launched in the United States in the coming weeks. The product will be available in three dosage strengths — 318 mg, 425 mg and 531 mg — corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively. Per management, the treatment requires no loading doses, oral supplementation or post-injection monitoring.
Weltruza offers an alternative to daily oral olanzapine, a widely prescribed atypical antipsychotic for schizophrenia. Weltruza is designed to help address treatment adherence challenges associated with daily medications by providing a once-monthly injection.
TEVA Price Performance
Year to date, shares of Teva have rallied 31.7% compared with the industry’s 9.2% rise.
Image Source: Zacks Investment Research
More on TEVA’s Weltruza FDA Nod
The latest FDA approval for Weltruza was based on results from the pivotal phase III SOLARIS study, which demonstrated improvements in schizophrenia symptoms, significant reduction in illness severity, and improvement in personal and social functioning.
The three Weltruza doses showed similar tolerability profiles. The most common adverse events included weight gain, somnolence, headache, constipation and injection-site reactions. Weight gain and metabolic changes were consistent with the known safety profile of oral olanzapine.
In December 2025, Teva submitted the new drug application (NDA) to the FDA seeking approval for Weltruza for treating adults with schizophrenia.
Teva’s marketing authorization application, seeking approval for olanzapine long-acting injectable (TEV-‘749) for treating adults with schizophrenia, is currently under review in Europe.
TEVA Seeks 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 six months of 2026, Uzedy’s sales surged 51% year over year to $140 million, mainly driven by volume growth. TEVA anticipates Uzedy sales to be in the range of $270-$290 million in 2026.
Management believes Uzedy has substantial long-term potential because long-acting injectable antipsychotics are increasingly being adopted in psychiatric care.
Also, the FDA nod to Weltruza should help Teva diversify and address a broader schizophrenia patient population.
Meanwhile, 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 (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.
Teva plans to begin other studies for duvakitug in two additional indications — hidradenitis suppurativa and fibrostenotic CD. The company believes duvakitug has pipeline-in-a-product potential.
Teva Pharmaceutical Industries Ltd. Price
Teva Pharmaceutical Industries Ltd. price | Teva Pharmaceutical Industries Ltd. Quote
TEVA's Zacks Rank & Stocks to Consider
Teva currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Actuate Therapeutics, Inc. (ACTU - Free Report) and CRISPR Therapeutics (CRSP - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Actuate Therapeutics’ 2026 loss per share have narrowed from 86 cents to 73 cents, while loss per share estimates for 2027 have declined from 78 cents to 59 cents during the same time. ACTU’s shares have plunged 90% year to date.
Actuate Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 8.21%.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have narrowed from $4.53 to $4.47, while loss per share estimates for 2027 have declined from $3.63 to $3.61 during the same time. CRSP’s shares have risen 1.9% year to date.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average negative surprise being 1.38%.