Teva Pharmaceuticals Submits Long-Acting Olanzapine Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 21 2026
0mins
Teva Pharmaceuticals International announced that the European Medicines Agency has accepted the Marketing Authorization Application for olanzapine long-acting injectable for the treatment of schizophrenia in adults. TEV-'749 aims to address treatment adherence in real-world settings and contribute to long-term disease management in people living with schizophrenia. TEV-'749 is not approved by any regulatory authority worldwide at this time. The submission to the EMA is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. Across clinical development, TEV-'749 demonstrated efficacy, a systemic safety profile, and exposure consistent with oral olanzapine. TEV-'749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled, steady, prolonged release of olanzapine.
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Analyst Views on TEVA
Wall Street analysts forecast TEVA stock price to rise
11 Analyst Rating
10 Buy
1 Hold
0 Sell
Strong Buy
Current: 34.520
Low
29.00
Averages
35.71
High
40.00
Current: 34.520
Low
29.00
Averages
35.71
High
40.00
About TEVA
Teva Pharmaceutical Industries Ltd is a Israeli-based pharmaceutical company. The Company operates through three segments: North America, Europe and International Markets. Each business segment manages entire product portfolio in its region, including generics, specialty and over-the-counter (OTC) products. In addition to these three segments, The Company has other activities, primarily the sale of active pharmaceutical ingredients (API) to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Teva and Medincell Submit Drug Application for Schizophrenia Treatment
- Drug Application Progress: Teva Pharmaceuticals International GmbH and Medincell announced that the European Medicines Agency has accepted their Marketing Authorization Application for the long-acting injectable olanzapine (TEV-'749), marking a significant advancement in the treatment of schizophrenia in adults.
- Technological Innovation: TEV-'749 utilizes Medincell's proprietary SteadyTeq copolymer technology, which enables controlled, steady, and prolonged release of olanzapine, expected to significantly enhance patient adherence and treatment outcomes.
- Clinical Support: The submission is backed by an extensive clinical development program, including the Phase 3 SOLARIS study, indicating that the drug has demonstrated good safety and efficacy in clinical trials.
- Market Dynamics: Although TEV-'749 has not yet been approved by any regulatory authority worldwide, Medincell's shares were trading at 26.62 euros, down 1.19% at the last close, reflecting market caution regarding the drug's future prospects.
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- Clinical Research Backing: The application for TEV-749 is supported by an extensive clinical development program, including the Phase 3 SOLARIS study, which demonstrated efficacy and safety profiles consistent with oral olanzapine, indicating its potential to transform schizophrenia treatment in real-world settings.
- Strong Market Demand: With schizophrenia affecting 0.3% to 1.5% of the population in Europe, patients often face challenges such as social isolation and reduced quality of life; the introduction of TEV-749 is expected to provide a more convenient treatment option, thereby improving their quality of life and social functioning.
- Strategic Growth Focus: As Teva advances TEV-749, it emphasizes its
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- Positive Market Response: This initiative may generate widespread attention in the pharmaceutical industry, especially regarding drug price transparency and affordability, potentially driving increased consumer demand for generics.
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- Debt Rating Improvement: Teva's senior unsecured debt and credit facilities ratings have also been raised to BBB-, reflecting the company's sustained progress in financial robustness and cash flow generation, which is expected to further support its operating margin improvement.
- Innovation-Driven Growth: Fitch anticipates continued growth in Teva's innovative revenues, primarily driven by products like AUSTEDO® and AJOVY®, along with upcoming launches such as olanzapine LAI, highlighting the company's strategic shift towards a higher-margin product portfolio.
- Enhanced Financial Flexibility: The ongoing cash flow generation and balance sheet strengthening will enhance Teva's financial flexibility, providing support for future investments and product development, thereby solidifying its leadership position in the biopharmaceutical sector.
See More
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- Future Potential: Teva's biosimilars segment is expected to deliver $800 million in revenue by 2027, further stabilizing and growing the company's legacy business, enhancing its competitive position in the market.
- Drug Pipeline Outlook: Teva plans to launch multiple new drugs between 2026 and 2030, potentially adding up to $7 billion in annual sales, showcasing the company's strong potential in drug development and market appeal.
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- Analyst Ratings Positive: In a survey by S&P Global, 12 out of 13 analysts rated Teva as a 'buy' or 'strong buy', indicating recognition of its potential 11% upside in the market.
- Significant Sales Growth: Teva's Austedo drug saw first-quarter sales jump 41% year-over-year to $578 million, driving overall performance improvements and further boosting market confidence.
- Improved Financial Health: As of March 31, 2026, Teva's financial leverage dropped to 67%, and the company expects to realize approximately $470 million in net savings from transformation initiatives, demonstrating proactive efforts in cost-cutting and financial health improvement.
See More
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- Drug Application Progress: Teva Pharmaceuticals International GmbH and Medincell announced that the European Medicines Agency has accepted their Marketing Authorization Application for the long-acting injectable olanzapine (TEV-'749), marking a significant advancement in the treatment of schizophrenia in adults.
- Technological Innovation: TEV-'749 utilizes Medincell's proprietary SteadyTeq copolymer technology, which enables controlled, steady, and prolonged release of olanzapine, expected to significantly enhance patient adherence and treatment outcomes.
- Clinical Support: The submission is backed by an extensive clinical development program, including the Phase 3 SOLARIS study, indicating that the drug has demonstrated good safety and efficacy in clinical trials.
- Market Dynamics: Although TEV-'749 has not yet been approved by any regulatory authority worldwide, Medincell's shares were trading at 26.62 euros, down 1.19% at the last close, reflecting market caution regarding the drug's future prospects.
See More
Teva Launches Long-Acting Injectable TEV-749 for Schizophrenia
- Regulatory Approval: Teva and Medincell announced that the European Medicines Agency has accepted the Marketing Authorization Application for TEV-749, designed to provide a long-acting treatment for schizophrenia every four weeks, addressing a significant gap in current treatment options and expected to greatly enhance patient adherence.
- Clinical Research Backing: The application for TEV-749 is supported by an extensive clinical development program, including the Phase 3 SOLARIS study, which demonstrated efficacy and safety profiles consistent with oral olanzapine, indicating its potential to transform schizophrenia treatment in real-world settings.
- Strong Market Demand: With schizophrenia affecting 0.3% to 1.5% of the population in Europe, patients often face challenges such as social isolation and reduced quality of life; the introduction of TEV-749 is expected to provide a more convenient treatment option, thereby improving their quality of life and social functioning.
- Strategic Growth Focus: As Teva advances TEV-749, it emphasizes its
See More
Mark Cuban to Join Trump for Generic Drug Announcement
- Pharmacy Collaboration: Mark Cuban's Cost Plus Drugs online pharmacy is set to collaborate with Trump's TrumpRx website to offer a wide range of generic medicines, which is expected to significantly reduce drug costs for consumers, particularly those without insurance.
- Significant Price Advantage: Cost Plus Drugs sells both branded and generic drugs at discounts below insurance-covered prices, with Cuban stating that a 30-day supply of the generic drug Eliquis costs $345, showcasing its competitive edge in the pharmaceutical market.
- Positive Market Response: This initiative may generate widespread attention in the pharmaceutical industry, especially regarding drug price transparency and affordability, potentially driving increased consumer demand for generics.
- Industry-Wide Impact: Cuban's involvement not only enhances the visibility of Cost Plus Drugs but may also compel other pharmaceutical companies to reconsider their pricing strategies, thereby triggering price competition across the industry.
See More
Teva Pharmaceutical's Credit Rating Upgraded to Investment Grade
- Credit Rating Upgrade: Fitch has upgraded Teva's corporate credit rating from BB+ to investment grade BBB-, marking a significant endorsement of the company's successful transformation and growth strategy, which enhances market confidence in its financial flexibility.
- Debt Rating Improvement: Teva's senior unsecured debt and credit facilities ratings have also been raised to BBB-, reflecting the company's sustained progress in financial robustness and cash flow generation, which is expected to further support its operating margin improvement.
- Innovation-Driven Growth: Fitch anticipates continued growth in Teva's innovative revenues, primarily driven by products like AUSTEDO® and AJOVY®, along with upcoming launches such as olanzapine LAI, highlighting the company's strategic shift towards a higher-margin product portfolio.
- Enhanced Financial Flexibility: The ongoing cash flow generation and balance sheet strengthening will enhance Teva's financial flexibility, providing support for future investments and product development, thereby solidifying its leadership position in the biopharmaceutical sector.
See More
Teva Pharmaceuticals Transforms, Poised for Growth
- Debt Reduction: Teva Pharmaceuticals has successfully reduced over $5 billion in debt over recent years, alleviating legal liabilities related to the opioid crisis, thereby improving its financial health and boosting market confidence.
- Branded Drug Growth: Despite a 1% decline in overall sales to $4 billion, the branded drug segment performed strongly, with Austedo generating $578 million in revenue, a 41% year-over-year increase, highlighting the significance of branded products in the company's revenue stream.
- Future Potential: Teva's biosimilars segment is expected to deliver $800 million in revenue by 2027, further stabilizing and growing the company's legacy business, enhancing its competitive position in the market.
- Drug Pipeline Outlook: Teva plans to launch multiple new drugs between 2026 and 2030, potentially adding up to $7 billion in annual sales, showcasing the company's strong potential in drug development and market appeal.
See More
Teva Pharmaceutical Stock Doubles, Analysts Remain Optimistic
- Stock Price Surge: Teva Pharmaceutical's stock has soared over 100% in the past 12 months, reflecting strong market confidence in its recovery, with analysts generally optimistic about its future performance.
- Analyst Ratings Positive: In a survey by S&P Global, 12 out of 13 analysts rated Teva as a 'buy' or 'strong buy', indicating recognition of its potential 11% upside in the market.
- Significant Sales Growth: Teva's Austedo drug saw first-quarter sales jump 41% year-over-year to $578 million, driving overall performance improvements and further boosting market confidence.
- Improved Financial Health: As of March 31, 2026, Teva's financial leverage dropped to 67%, and the company expects to realize approximately $470 million in net savings from transformation initiatives, demonstrating proactive efforts in cost-cutting and financial health improvement.
See More
