Teva's TEV-'749 New Drug Application Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 20 2026
0mins
Should l Buy TEVA?
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Medincell announced that the U.S. Food and Drug Administration has accepted its New Drug Applicationfor olanzapine extended-release injectable suspension for the treatment of schizophrenia in adults. "TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia. Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy, which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring," the company stated.
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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: 33.860
Low
29.00
Averages
35.71
High
40.00
Current: 33.860
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 Pharmaceutical Stock Doubles, Strong Outlook Ahead
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- Strategic Shift: Teva is pivoting from generic drugs to specialty pharmaceuticals, with strong sales from branded drugs like Austedo, Ajovy, and Uzedy offsetting flat generic sales, and these products are expected to comprise a larger share of revenue, enhancing overall profitability.
- Future Growth Potential: Management anticipates that the drug candidate duvakitug could achieve peak annual sales of $2 billion to $5 billion, and with other pipeline candidates, the total sales potential exceeds $10 billion, showcasing Teva's strong competitive position in the future market.
- Attractive Valuation: Currently trading at around 12.5 times forward earnings, Teva is positioned in the middle to lower end of the pharmaceutical valuation range, providing long-term investors an opportunity to enter before potential price appreciation, especially if the stock price dips.
See More
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- Risky Business Transformation: Teva is not only focusing on generics but also developing original drugs, which presents opportunities for success but also exposes the company to significant competition from more experienced firms, increasing business uncertainty.
- Financial Performance Overview: With a market cap of $39 billion and a current stock price of $33.85, Teva's gross margin stands at 51.82%, indicating profitability in the generics market, yet market confidence in its future growth remains low.
- Cautious Investor Sentiment: While Teva's business model attracts some investors, conservative investors may be wary of the risks associated with its transformation, particularly in the highly competitive pharmaceutical sector.
See More
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- Business Model Transition Risks: Teva is not only focusing on complex generics but also developing its own drugs, which presents potential success opportunities but also comes with fierce competition from more experienced companies, increasing investment risks.
- Cautious Investor Sentiment: Due to the risks associated with Teva's business model changes, conservative investors may adopt a cautious stance regarding its future performance, especially in the highly competitive pharmaceutical sector.
- Lack of Market Recommendations: Despite Teva's strong performance in generics, it was not included in the current list of top investment stocks by analysts, indicating market concerns about its future growth potential.
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Teva's New Drug Application Accepted by FDA for Schizophrenia Treatment
- NDA Progress: Teva Pharmaceuticals announced that its New Drug Application for TEV-‘749, an extended-release injectable for schizophrenia, has been accepted by the FDA, marking a significant milestone in the mental health sector aimed at improving patient adherence to treatment.
- Clinical Trial Results: In the Phase 3 SOLARIS trial, TEV-‘749 demonstrated an efficacy and safety profile comparable to existing formulations, administered as a once-monthly subcutaneous injection, eliminating the need for post-injection monitoring, showcasing its clinical advantages.
- Market Potential: Teva's other schizophrenia drug, Uzedy, generated $191 million in revenue for fiscal 2025, reflecting a 63% increase and exceeding management expectations, indicating strong performance and growth potential in the mental health drug market.
- Stock Performance Analysis: Although Teva's stock fell 1.37% to $33.75 in premarket trading, it has risen 12.4% over the past 12 months, indicating relative strength in the market, with analysts maintaining an optimistic outlook and an average price target of $34.09.
See More
Teva Pharmaceutical Stock Doubles, Strong Outlook Ahead
- Earnings Beat: Teva Pharmaceutical reported fourth-quarter revenue of $4.7 billion for 2025, an 11% year-over-year increase, with adjusted EPS at $0.96, significantly surpassing the analyst forecast of $0.64, indicating robust financial performance and market demand.
- Strategic Shift: Teva is pivoting from generic drugs to specialty pharmaceuticals, with strong sales from branded drugs like Austedo, Ajovy, and Uzedy offsetting flat generic sales, and these products are expected to comprise a larger share of revenue, enhancing overall profitability.
- Future Growth Potential: Management anticipates that the drug candidate duvakitug could achieve peak annual sales of $2 billion to $5 billion, and with other pipeline candidates, the total sales potential exceeds $10 billion, showcasing Teva's strong competitive position in the future market.
- Attractive Valuation: Currently trading at around 12.5 times forward earnings, Teva is positioned in the middle to lower end of the pharmaceutical valuation range, providing long-term investors an opportunity to enter before potential price appreciation, especially if the stock price dips.
See More
Teva Pharmaceutical's Investment Opportunities and Risks
- Increased Market Competition: Teva Pharmaceutical's generics business faces intensifying competition, leading to declining profits; although the company excels in complex generics, it requires more investment and entails higher risks.
- Risky Business Transformation: Teva is not only focusing on generics but also developing original drugs, which presents opportunities for success but also exposes the company to significant competition from more experienced firms, increasing business uncertainty.
- Financial Performance Overview: With a market cap of $39 billion and a current stock price of $33.85, Teva's gross margin stands at 51.82%, indicating profitability in the generics market, yet market confidence in its future growth remains low.
- Cautious Investor Sentiment: While Teva's business model attracts some investors, conservative investors may be wary of the risks associated with its transformation, particularly in the highly competitive pharmaceutical sector.
See More
Teva Pharmaceuticals Faces Competition and Risks in Drug Development
- Increased Market Competition: Teva Pharmaceuticals faces heightened competition in the generics market, leading to declining profits; while it has an edge in complex generics, it requires more investment to maintain its market position.
- Business Model Transition Risks: Teva is not only focusing on complex generics but also developing its own drugs, which presents potential success opportunities but also comes with fierce competition from more experienced companies, increasing investment risks.
- Cautious Investor Sentiment: Due to the risks associated with Teva's business model changes, conservative investors may adopt a cautious stance regarding its future performance, especially in the highly competitive pharmaceutical sector.
- Lack of Market Recommendations: Despite Teva's strong performance in generics, it was not included in the current list of top investment stocks by analysts, indicating market concerns about its future growth potential.
See More
Bridger Management Sells Entire Stake in Bath & Body Works Amid Struggles
- Share Sale Details: Bridger Management disclosed the sale of 300,619 shares of Bath & Body Works in Q4 2026, with an estimated transaction value of $7.74 million, indicating a strategic exit during a challenging market phase.
- Declining Company Performance: As of February 17, 2026, Bath & Body Works shares were priced at $24.67, down 32.3% year-over-year and underperforming the S&P 500 by 38.07 percentage points, highlighting its struggles in a competitive landscape.
- Fund Downsizing: Bridger Management's total assets under management (AUM) shrank by 16% quarter-over-quarter, reflecting a lack of confidence in market recovery, particularly given the poor performance during its holding period of Bath & Body Works.
- Uncertain Market Outlook: Despite a modest rebound in late 2025, Bath & Body Works faces ongoing challenges with stagnant sales and declining appeal among younger consumers, leading analysts to forecast lower sales in 2026, indicating significant long-term hurdles for the company.
See More
Bridger Management Exits BBWI Stake Amid Market Challenges
- Share Sale Details: Bridger Management disclosed to the SEC on February 17, 2026, that it sold 300,619 shares of Bath & Body Works, with an estimated trade value of $7.74 million, reflecting strategic decisions amid market volatility.
- Asset Management Shift: This transaction resulted in a 4.98% change in Bridger's 13F reportable AUM, indicating that the fund no longer holds any shares post-trade, which suggests a lack of confidence in the company's future performance.
- Market Environment Challenges: Bath & Body Works has faced stagnating sales and declining popularity among Gen Z consumers in recent years, and despite a slight rebound in stock price at the end of 2025, Bridger's exit indicates a cautious outlook on future growth.
- Investor Advisory: Following Bridger's exit, analysts advise caution for investors considering Bath & Body Works stock, as the company did not make it onto Motley Fool's list of top 10 stocks, reflecting broader market concerns about its future performance.
See More
Teva's New Drug Application Accepted by FDA for Schizophrenia Treatment
- NDA Progress: Teva Pharmaceuticals announced that its New Drug Application for TEV-‘749, an extended-release injectable for schizophrenia, has been accepted by the FDA, marking a significant milestone in the mental health sector aimed at improving patient adherence to treatment.
- Clinical Trial Results: In the Phase 3 SOLARIS trial, TEV-‘749 demonstrated an efficacy and safety profile comparable to existing formulations, administered as a once-monthly subcutaneous injection, eliminating the need for post-injection monitoring, showcasing its clinical advantages.
- Market Potential: Teva's other schizophrenia drug, Uzedy, generated $191 million in revenue for fiscal 2025, reflecting a 63% increase and exceeding management expectations, indicating strong performance and growth potential in the mental health drug market.
- Stock Performance Analysis: Although Teva's stock fell 1.37% to $33.75 in premarket trading, it has risen 12.4% over the past 12 months, indicating relative strength in the market, with analysts maintaining an optimistic outlook and an average price target of $34.09.
See More
