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New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed
Globenewswire· 2025-09-21 02:15
Core Insights - Teva Pharmaceuticals presented new data on its schizophrenia treatment portfolio, including long-term safety results from the SOLARIS Phase 3 trial for olanzapine LAI (TEV-'749), which showed no incidence of post-injection delirium/sedation syndrome (PDSS) [1][4] - The data also highlighted UZEDY, an extended-release injectable suspension of risperidone, which was associated with shorter hospitalization compared to Invega Sustenna, although no direct comparisons on efficacy or safety were made [1][9] Olanzapine LAI (TEV-'749) Data - The SOLARIS trial involved 675 participants aged 18-64, with a randomized double-blind placebo-controlled period followed by an open-label safety period [3][17] - No PDSS events were reported across 3,470 total injections, indicating a favorable safety profile consistent with other olanzapine formulations [4][5] - Long-term effectiveness data showed significant symptom improvement, with a mean change of -7.2 in PANSS total scores and a 4.6-point increase in PSP scores from baseline [7][8] UZEDY Data - A retrospective study indicated that UZEDY led to a 2.89-day shorter length of hospital stay compared to Invega Sustenna, translating to estimated direct cost savings of $3,200 per hospitalization [9] - UZEDY was preferred by healthcare professionals for its ease of administration and dosing characteristics, with 45% favoring it over Invega Sustenna [9][10] Company Commitment - Teva is dedicated to developing innovative treatments for complex neurological conditions, aiming to address unmet needs in mental health care [5][14] - The company plans to submit a New Drug Application (NDA) for olanzapine LAI (TEV-'749) in the second half of 2025 [13][15]
Teva to Host Conference Call to Discuss Data from the Completed Phase 3 SOLARIS Trial For Olanzapine LAI (TEV-‘749) on September 22, 2025 After Presentations at the Psych Congress Annual meeting
Globenewswire· 2025-09-16 20:30
Core Insights - Teva Pharmaceutical Industries Ltd. plans to present data from the completed phase 3 SOLARIS trial at the 2025 Psych Congress Annual Meeting in San Diego, California, from September 17 to 21, 2025 [1] - A conference call for analysts and investors will be held on September 22, 2025, at 11:00 a.m. ET to discuss the trial data [1] Company Overview - Teva is a leading innovative biopharmaceutical company with a strong generics business, committed to addressing patients' needs for over 120 years [3] - The company focuses on innovation in neuroscience and immunology, as well as providing complex generic medicines, biosimilars, and pharmacy brands globally [3]
Teva Pharmaceutical Industries (TEVA) Attains FDA’s Fast Track Designation for Emrusolmin
Yahoo Finance· 2025-09-16 18:58
Group 1: Company Overview - Teva Pharmaceutical Industries Limited (NYSE:TEVA) is recognized as one of the best drug stocks to buy currently [1] - The company develops, produces, and sells medicines across various segments including specialty, generics, and over-the-counter (OTC) products [4] Group 2: Product Development - Teva announced on September 9 that it received Fast Track designation from the U.S. FDA for emrusolmin, an investigational treatment for Multiple System Atrophy (MSA) currently in Phase 2 development [1] - Emrusolmin is part of a strategic collaboration with MODAG GmbH and is being evaluated in a Phase 2 trial to assess its efficacy and safety, targeting the alpha synuclein protein involved in MSA pathogenesis [3] - The U.S. FDA granted Orphan Drug designation to emrusolmin for MSA in 2022, highlighting the urgent need for new therapeutic options for this rare neurodegenerative disorder [2][3]
Tuesday's ETF with Unusual Volume: EFG
Nasdaq· 2025-09-16 16:25
Group 1 - The iShares MSCI EAFE Growth ETF is experiencing unusually high trading volume, with over 10.5 million shares traded compared to a three-month average of approximately 647,000 shares [1] - The ETF's shares are down about 0.5% on the day [1] Group 2 - The components of the ETF with the highest trading volume include Grab Holdings, which is down about 2.2% with over 39.6 million shares traded, and Teva Pharmaceutical, down about 0.7% with over 4.2 million shares changing hands [2] - WIX.COM is performing the best among the components, up about 3.5% on the day, while Futu Holdings is lagging, down about 2.9% [2]
Teva Pharmaceutical Industries Limited (TEVA)’s Emrusolmin Gains FDA Fast Track for Multiple System Atrophy
Yahoo Finance· 2025-09-16 13:26
Core Insights - Teva Pharmaceutical Industries Limited is transitioning from a generics-focused firm to a biopharmaceutical leader, with a strong emphasis on specialty products and biopharmaceutical innovation [1][2]. Group 1: Growth Strategy - Teva's growth strategy includes key products such as Austedo, which is expected to surpass $2.5 billion in sales by 2027, and Uzedy, projected to reach $200 million in 2025 [2]. - The company plans to launch five new biosimilars by 2027 and aims for a 30% operating margin within the same timeframe [2]. Group 2: Innovative Pipeline - Teva's investigational drug emrusolmin (TEV-56286) received FDA Fast Track designation for the treatment of Multiple System Atrophy (MSA), highlighting the company's commitment to developing high-value therapies for serious conditions [3].
J.P. Morgan Maintains a Buy on Teva Pharmaceutical (TEVA) With a $23 PT
Yahoo Finance· 2025-09-11 16:49
Group 1 - Teva Pharmaceutical Industries Limited (NYSE:TEVA) is recognized as one of the best growth stocks under $50, with a Buy rating maintained by J.P. Morgan analyst Chris Schott and a price target set at $23.00 [1] - On August 28, Teva announced the FDA approval and U.S. launch of Generic Saxenda, the first-ever generic GLP-1 therapy indicated for weight loss, addressing the increasing demand for such therapies in the U.S. market [2] - The Liraglutide injection is indicated for adults with obesity or overweight who have weight-related medical issues, as well as for pediatric patients aged 12-17 years with obesity, aiming to assist in weight loss and maintenance [3] Group 2 - Teva operates in various geographical segments, including the U.S., Europe, and International Markets, covering a comprehensive product portfolio that includes specialty, generics, and over-the-counter (OTC) products [3] - While Teva shows potential as an investment, there are opinions suggesting that certain AI stocks may offer greater upside potential and carry less downside risk [4]
Here’s Why Sound Shore Fund Added Teva Pharmaceutical Industries Limited (TEVA) in Q2
Yahoo Finance· 2025-09-10 14:18
Sound Shore Management, an investment management firm, has released its investor letter for the second quarter of 2025. A copy of the letter can be downloaded here. The fund’s Investor Class (SSHFX) and Institutional Class (SSHVX) delivered 3.06% and 3.10%, respectively, in the second quarter of 2025 compared to a 3.79% return for the Russell 1000 Value Index (Russell Value) and 10.94% return for the Standard & Poor 500 Index (S&P 500). Sound Shore’s 35-year annualized returns were 14.92% and 15.14% for SSH ...
Teva Pharmaceutical Industries Limited (TEVA) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-09 16:57
Core Insights - The session focuses on Teva and includes an introduction by Richard Francis, the CEO of Teva, discussing the company's current situation and outlook [2] Company Overview - Richard Francis, CEO of Teva, is present to provide insights into the company's status and future prospects [2] Industry Context - The session is part of a broader equity research initiative led by Morgan Stanley, indicating a focus on pharmaceutical industry analysis [1]
Teva Pharmaceutical Industries (NYSE:TEVA) FY Conference Transcript
2025-09-09 13:32
Teva Pharmaceutical Industries FY Conference Summary Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **Date of Conference**: September 09, 2025 - **Key Speaker**: Richard Francis, CEO of Teva Core Industry Insights - **Transition Strategy**: Teva has been executing a "Pivot to Growth" strategy for over two years, transitioning from a pure-play generics company to a biopharmaceutical company, achieving 10 consecutive quarters of growth [2][4] - **Generics Business**: The generics segment is expected to represent 25% of Teva's global generics business after the loss of Revlimid generic revenues next year, indicating a shift in focus towards innovative products [42] Key Financial Metrics - **Growth Metrics**: Despite a 2% decline in the generics business in Q2 2024, Teva reported growth in gross margin, EBITDA, operating margin, and EPS, demonstrating the strength of its innovative portfolio [4] - **Revenue Targets**: Teva aims for Austedo to exceed $3 billion in revenue by 2027, driven by increased patient adherence and optimal dosing [16][17] Product Pipeline and Innovations - **Innovative Pipeline**: Teva's pipeline includes high-quality assets such as olanzapine and Uzedy, with expectations of significant market impact in treating schizophrenia [19][20] - **ICS-SABA Combination**: Teva has a $1 billion target for its dual-action rescue inhaler, with confidence stemming from the large patient population that should be on combination therapy [28][30] Market Dynamics and Competitive Landscape - **Generics Market**: Teva's generics business is positioned for low single-digit growth, supported by a robust pipeline and a transformation in manufacturing capabilities [43] - **Direct-to-Consumer Channels**: Teva is exploring direct-to-consumer cash pay channels, which could enhance value retention and patient access [9] Strategic Focus and Future Outlook - **Execution of Strategy**: Teva is in the acceleration phase of its growth strategy, focusing on innovative assets and maintaining a disciplined approach to capital allocation [51][52] - **Long-term Goals**: Teva aims for a 30% operating margin, 5% CAGR revenue growth, and a net debt/EBITDA ratio of two times by 2027 [52] Additional Considerations - **Regulatory Environment**: Teva is monitoring potential U.S. tariffs on pharmaceuticals, with a strong manufacturing footprint in the U.S. mitigating risks [7][8] - **Partnerships and Collaborations**: Teva has engaged in strategic partnerships to enhance its pipeline without significant capital investment, particularly in the GLP-1 market [48][49] This summary encapsulates the key points discussed during the conference, highlighting Teva's strategic direction, financial performance, and product pipeline developments.
Teva’s Emrusolmin Granted U.S. FDA Fast Track Designation for Treatment of Multiple System Atrophy
Globenewswire· 2025-09-09 12:30
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression.Emrusolmin is a small molecule that targets the alpha synuclein protein, which is believed to be pivotally involved in the pat ...