TEVA Files NDA With FDA for Olanzapine LAI for Schizophrenia

Teva Pharmaceutical Industries Limited TEVA 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 PerformanceYear to date, shares of Teva have rallied 29.6% compared with the industry’s 27.9% rise.Image Source: Zacks Investment ResearchFDA Nod Could Broaden Teva’s Schizophrenia PortfolioTEVA 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 GrowthTeva 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 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 ConsiderTeva currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP and Castle Biosciences CSTL, 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%.Zacks Naming Top 10 Stocks for 2026Want to be tipped off early to our 10 top picks for the entirety of 2026? History suggests their performance could be sensational.From 2012 (when our Director of Research Sheraz Mian assumed responsibility for the portfolio) through November, 2025, the Zacks Top 10 Stocks gained +2,530.8%, more than QUADRUPLING the S&P 500’s +570.3%.Now Sheraz is combing through 4,400 companies to handpick the best 10 tickers to buy and hold in 2026. Don’t miss your chance to get in on these stocks when they’re released on January 5. Be First to New Top 10 Stocks >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Teva Pharmaceutical Industries Ltd. (TEVA): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks