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Positive Phase 3 Data Demonstrate Potential for ENTYVIO® (vedolizumab) to Address Treatment Gap for Children and Adolescents with Moderate to Severe Ulcerative Colitis
Financialpost· 2026-02-19 17:22
Article contentFor the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, othe ...
Patients with Crohn's disease maintained steroid-free remission for three years with Lilly's Omvoh (mirikizumab-mrkz)
Prnewswire· 2026-02-19 17:15
Core Insights - Eli Lilly's Omvoh (mirikizumab-mrkz) demonstrated durable efficacy in maintaining steroid-free remission in over 90% of patients with Crohn's disease for three years, as per the VIVID-2 study results [1][2] - The treatment also showed significantly low rates of hospitalizations and surgeries in patients with both Crohn's disease and ulcerative colitis, indicating its potential to alter disease progression [1][2] - Omvoh is the only IL-23p19 inhibitor to exhibit strong and sustained efficacy over four years in ulcerative colitis and three years in Crohn's disease, with consistent monthly dosing [1][2] Efficacy and Remission - In the VIVID-2 study, 92.4% of patients maintained clinical remission, and 91.2% achieved corticosteroid-free clinical remission after three years of treatment [1][2] - Improvements in bowel urgency were noted, with 82.1% of patients experiencing a 3-point reduction on the Urgency Numeric Rating Scale (UNRS) [1][2] - Sustained improvement in inflammation was observed, with a continued decrease in inflammatory biomarkers over three years [1][2] Safety and Complications - The long-term safety profile of Omvoh remained consistent with known safety data, with common adverse events including upper respiratory tract infections and arthralgia [1][2][3] - Omvoh reduced Crohn's disease-related hospitalizations and surgeries by nearly 50% in the first 12 weeks compared to placebo, and by nearly 70% during weeks 12 to 52 [1][2] - In the LUCENT-3 study for ulcerative colitis, only one hospitalization and no surgeries were reported during the three-year extension [1][2] Regulatory and Clinical Development - Omvoh has received regulatory approvals for treating moderately to severely active ulcerative colitis and Crohn's disease in adults across 47 countries [2] - Ongoing studies are exploring combination therapies with mirikizumab to enhance treatment efficacy while maintaining long-term safety [2] - Pediatric trials for Omvoh in ulcerative colitis and Crohn's disease are also in progress [2]
Corcept Therapeutics Stock Plunges As Court Clears Teva Generic
Benzinga· 2026-02-19 16:48
Corcept Therapeutics shares are approaching critical lows. What’s pressuring CORT?Appeals Court Upholds Ruling Against CorceptCorcept had argued that Teva's label for its generic version of Korlym, a drug used to treat Cushing's syndrome, would induce doctors to follow patented dosing methods involving mifepristone and strong CYP3A inhibitors such as ketoconazole. The appeals court agreed with the lower court that there was no proof doctors had used, or were likely to use, those specific regimens, especiall ...
Catalyst Pharmaceuticals: Clear Path Forward For Growth In 2 FDA-Approved Drugs
Seeking Alpha· 2026-02-19 16:39
Core Viewpoint - Catalyst Pharmaceuticals, Inc. (CPRX) has a solid business model that is driving growth, particularly in the healthcare sector, as highlighted in the recent analysis [1]. Group 1: Company Overview - Catalyst Pharmaceuticals has been the focus of research for approximately five years, emphasizing its potential in the healthcare market [1]. Group 2: Investment Perspective - The article reflects on the learning process of investing, where both successes and failures contribute to valuable lessons [1].
Cosmos Health Highlights Approximately $15 Million Fair Market Value of Real Estate Assets, Exceeding Current Market Capitalization; Evaluates Monetization Options to Address Significant Discount to Book Value
Globenewswire· 2026-02-19 16:30
CHICAGO, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today highlighted the intrinsic value of its wholly owned real estate portfolio and announced that it is evaluating strategic monetization options to unlock shareholder value. Based on independent valuation reports, recent market data, and comparable transactions, management estimates the combined fair market value of the Company’s Cana ...
Cosmos Health Highlights Approximately $15 Million Fair Market Value of Real Estate Assets, Exceeding Current Market Capitalization; Evaluates Monetization Options to Address Significant Discount to Book Value
Globenewswire· 2026-02-19 16:30
CHICAGO, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today highlighted the intrinsic value of its wholly owned real estate portfolio and announced that it is evaluating strategic monetization options to unlock shareholder value. Based on independent valuation reports, recent market data, and comparable transactions, management estimates the combined fair market value of the Company’s Cana ...
Bristol-Myers Squibb: Oncology Franchise Remains A Core Strength (NYSE:BMY)
Seeking Alpha· 2026-02-19 16:28
Bristol-Myers Squibb Company ( BMY ) shares have risen 27.7% since my last article , "Why Bristol-Myers Squibb Remains Undervalued In 2025," in mid-November. They have outperformed the S&P 500 [3.6% return] ( SPY ) during that time.With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, techno ...
Bristol-Myers Squibb: Oncology Franchise Remains A Core Strength
Seeking Alpha· 2026-02-19 16:28
Bristol-Myers Squibb Company ( BMY ) shares have risen 27.7% since my last article , "Why Bristol-Myers Squibb Remains Undervalued In 2025," in mid-November. They have outperformed the S&P 500 [3.6% return] ( SPY ) during that time.With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, techno ...
Pfizer Targets Long-Term Oncology Growth Amid Competitive Pressure
ZACKS· 2026-02-19 16:15
Core Insights - Pfizer is a leading player in the oncology market with a diverse portfolio of approved cancer medicines and a strong pipeline focused on various modalities [1][9] Oncology Sales Performance - Oncology sales account for approximately 27% of Pfizer's total revenues, with an 8% growth in 2025 driven by key drugs such as Xtandi, Lorbrena, Braftovi-Mektovi combination, and Padcev [2][11] - Xtandi generated alliance revenues of $2.19 billion in 2025, up 8% year over year, while Lorbrena sales increased by 40% to $1.02 billion [3] - Padcev sales rose 22% to $1.94 billion, supported by strong demand trends, while Ibrance revenues declined by 6% to $4.1 billion [4][11] Pipeline and Future Growth - Pfizer is investing in Padcev, which has received FDA approval for a combination treatment with Merck's Keytruda for muscle-invasive bladder cancer, potentially expanding its patient population [5][9] - The oncology biosimilars segment contributed $1.3 billion in sales, reflecting a 26% year-over-year increase [6] - Pfizer's late-stage pipeline includes candidates like atirmociclib and sigvotatug vedotin, with expectations of having eight or more blockbuster oncology medicines by 2030 [7][11] Competitive Landscape - Pfizer competes with major players in the oncology space, including AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers [10] - AstraZeneca's oncology sales rose 14% in 2025, while Merck's Keytruda accounted for over 50% of its pharmaceutical sales, reaching $31.7 billion [12][13] Stock Performance and Valuation - Pfizer's stock has increased by 5.7% over the past year, compared to a 17.3% rise in the industry [18] - The company's shares are trading at a forward price/earnings ratio of 9.28, lower than the industry average of 18.86 and its own 5-year mean of 10.22 [20]
What Analyst Projections for Key Metrics Reveal About Jazz (JAZZ) Q4 Earnings
ZACKS· 2026-02-19 15:16
Wall Street analysts forecast that Jazz Pharmaceuticals (JAZZ) will report quarterly earnings of $6.62 per share in its upcoming release, pointing to a year-over-year increase of 0.3%. It is anticipated that revenues will amount to $1.18 billion, exhibiting an increase of 8.4% compared to the year-ago quarter.The consensus EPS estimate for the quarter has undergone a downward revision of 13% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have re ...