Invega Sustenna
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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]
Will AbbVie's Neuroscience Portfolio Continue to Aid Top-line Growth?
ZACKS· 2025-09-04 14:21
Core Insights - AbbVie has developed a strong neuroscience franchise, initially driven by blockbuster drugs like Botox Therapeutic and Vraylar, and has expanded its portfolio with new migraine treatments Qulipta and Ubrelvy, as well as Vyalev for Parkinson's disease [1][2]. Financial Performance - The neuroscience segment contributed over 17% to AbbVie's total sales in the first half of 2025, with revenues growing nearly 21% year over year, primarily due to increased sales of Botox Therapeutic and Vraylar, along with rising uptake of Ubrelvy and Qulipta [2][9]. - The strong performance in the neuroscience segment has helped mitigate the decline in Duodopa sales [2][9]. Product Launches and Acquisitions - AbbVie launched Vyalev in the U.S. earlier this year, and while initial sales have been modest, expectations are for its contribution to total revenues to grow over time [3]. - The company is actively investing in new therapies, including a recent agreement to acquire Gilgamesh Pharmaceuticals' lead pipeline drug for approximately $1.2 billion, which targets major depressive disorder (MDD). This follows a $1.4 billion acquisition of Aliada Therapeutics, which added an investigational antibody for Alzheimer's disease (AD) [4][5]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson. Biogen is diversifying its offerings due to declining revenues in its multiple sclerosis franchise and has partnered with Eisai to market an FDA-approved treatment for Alzheimer's disease [6]. - Johnson & Johnson has a strong neuroscience portfolio, including the antidepressant nasal spray Spravato and the antipsychotic Invega Sustenna, and recently acquired Intra-Cellular Therapies to enhance its offerings [7]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a premium with a price/earnings (P/E) ratio of 15.59, compared to the industry average of 14.84 and above its five-year mean of 12.82 [8][11]. - Earnings per share (EPS) estimates for 2025 and 2026 have seen slight increases in the past 30 days [12].
How Will AbbVie's Neuroscience Franchise Perform in Q2 Earnings?
ZACKS· 2025-07-22 14:35
Core Insights - AbbVie holds a leadership position in the neuroscience space, with significant products including Botox Therapeutic and Vraylar, contributing to over 17% of the company's first-quarter revenues, which grew 16% year over year [1][10]. Neuroscience Franchise Performance - The neuroscience franchise is estimated to generate $2.5 billion in sales for Q2 2025, reflecting a 15% year-over-year growth, driven by higher sales of Botox Therapeutic and Vraylar, along with market share gains for Ubrelvy and Qulipta [2][10]. - Newly launched Vyalev is expected to contribute modest sales in the U.S., with the majority of its revenue coming from international markets [3][10]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson [5]. - Biogen generates over half of its revenue from neuroscience therapies and markets FDA-approved treatments for Alzheimer's disease and postpartum depression [6]. - Johnson & Johnson's neuroscience portfolio includes leading products like Spravato and Invega Sustenna, with recent acquisitions enhancing its offerings [8]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a price/earnings (P/E) ratio of 14.06, slightly below the industry average of 14.60 [9][12]. - EPS estimates for 2025 have decreased from $12.32 to $11.98, while estimates for 2026 have increased from $14.06 to $14.08 over the past month [13].
ETFs to Gain on JNJ's Solid Q1 Earnings & Upbeat Outlook
ZACKS· 2025-07-17 16:01
Core Insights - Johnson & Johnson (JNJ) reported stronger-than-expected second-quarter 2025 results, continuing its streak of earnings beats and exceeding revenue estimates [1][3] - The company raised its revenue guidance for fiscal 2025 and increased its quarterly dividends [5][6] Financial Performance - JNJ's earnings per share (EPS) was $2.77, beating the Zacks Consensus Estimate of $2.66, but declined 1.8% year-over-year [3] - Revenues grew 5.8% year-over-year to $23.74 billion, surpassing the Zacks Consensus Estimate of $22.80 billion [3] - Innovative Medicines sales advanced 4.9%, while MedTech device sales jumped 7.3% [4] - Sales of Darzalex, a blood cancer treatment, increased 23% to $3.5 billion, while Xarelto generated $621 million, up 5.6% year-over-year [4] Guidance and Outlook - JNJ raised its revenue guidance for fiscal 2025 to $93.2-$93.6 billion from $91.0-$91.8 billion, indicating year-over-year growth of 5.1%-5.6% [5] - Adjusted EPS guidance was lifted to $10.80-$10.90 from $10.50-$10.70 due to stronger top-line performance and reduced tariff impact [5] Dividend and Price Target - The quarterly dividend was increased to $1.30 per share from $1.24, marking the 63rd consecutive annual increase [6] - Stifel raised its price target on JNJ to $165.00 from $155.00, citing confidence from multiple new product launches [6] ETFs in Focus - iShares U.S. Pharmaceuticals ETF (IHE) has a 22.7% allocation to JNJ, with $561.2 million in AUM [7] - VanEck Vectors Pharmaceutical ETF (PPH) holds 10.3% of its assets in JNJ, with $534.6 million in AUM [8] - Health Care Select Sector SPDR Fund (XLV) has JNJ at 7.7% of its assets, managing $33.8 billion [9][10] - iShares U.S. Healthcare ETF (IYH) allocates 7.5% to JNJ, with $2.7 billion in AUM [11] - First Trust Nasdaq Pharmaceuticals ETF (FTXH) also has JNJ as the top holding at 7.5% of its assets [12]
ETFs in Focus Post JNJ's Q1 Earnings Beat, Dividend Hike
ZACKS· 2025-04-16 15:00
Core Insights - Johnson & Johnson (JNJ) reported stronger-than-expected first-quarter 2025 results, continuing its streak of earnings beats and exceeding revenue estimates [1][3] - The company raised its revenue guidance for fiscal 2025 amid tariff challenges and increased its quarterly dividends [1][5][6] Financial Performance - JNJ's first-quarter earnings per share were $2.77, beating the Zacks Consensus Estimate of $2.57 and improving 2.2% year-over-year [3] - Revenues grew 2.4% year-over-year to $21.89 billion, surpassing the Zacks Consensus Estimate of $21.62 billion [3] - Innovative Medicines sales advanced 4.2%, while MedTech device sales jumped 4.1% [4] - Sales of Darzalex, a blood cancer treatment, increased 20% to $3.2 billion, and Xarelto sales rose 33% year-over-year to $690 million [4] - However, Stelara sales declined 34% to $1.6 billion due to new biosimilars entering the market, and Invega Sustenna sales dropped 15% to $903 million [4] Revenue Guidance - JNJ raised its revenue guidance for fiscal 2025 to $91.0-$91.8 billion from $89.2-$90.0 billion, indicating year-over-year growth of 2.6%-3.6% [5] - The new guidance reflects the addition of Caplyta following the $14.6 billion acquisition of Intra-Cellular Therapies [5] - The company maintained its adjusted earnings per share guidance in the range of $10.50-$10.70, accounting for tariff costs and dilution from the acquisition [5] Dividend Increase - JNJ increased its quarterly dividend to $1.30 per share from $1.24 per share, marking the 63rd consecutive year of dividend increases [6] - The annual dividend now totals $5.20 per share compared to the previous $4.96 per share [6] ETFs with JNJ Exposure - Investors are encouraged to consider ETFs with significant allocations to JNJ, including iShares U.S. Pharmaceuticals ETF (IHE), iShares U.S. Healthcare ETF (IYH), First Trust Nasdaq Pharmaceuticals ETF (FTXH), Health Care Select Sector SPDR Fund (XLV), and VanEck Vectors Pharmaceutical ETF (PPH) [2] - JNJ accounts for 24.5% of IHE, 7.2% of IYH, 7.8% of FTXH, 7.4% of XLV, and 6.7% of PPH [7][9][12][13][15]