CLEVELAND, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Mohamad Tabrizi, M.S., M.B.A., as Senior Vice President, Chief Business Officer (CBO). In this role, Mr. Tabrizi will lead the Company’s corporate strategy and business development functions, as well as drive operating efficiency for the Company. “Mohamad brings a wealth of experience in strategic planning and business development,” said Vish Seshadri, Chief Executive Officer of Abeona. “W ...

December 12, 2025 05:02 AM GMT Biopharma | North America 2026 Outlook: Policy in the rearview, fundamentals in the driver's seat As we head into 2026 we expect many of the policy overhangs that dominated the Biopharma conversation to wane, bringing the focus back to fundamentals, where the balance lies with new products+pipelines+M&A vs. LOE's. Policy overhangs (specifically most-favored nation (MFN) drug pricing dynamics) were front and center throughout the majority of 2025. In our opinion that overhang h ...

Core Insights - The rise of artificial intelligence (AI) has significantly impacted the stock market, benefiting technology companies and growth-oriented investments while putting pressure on dividend-focused funds like the Schwab U.S. Dividend Equity ETF (SCHD) [2][4] Group 1: ETF Overview - The Schwab U.S. Dividend Equity ETF tracks the Dow Jones U.S. Dividend 100 Index, focusing on high-quality U.S. firms with consistent dividend payments and strong financial ratios [3] - The ETF currently offers a trailing yield of approximately 3.8%, which is higher than the S&P 500's payout, and has a low expense ratio of 0.06% [3] Group 2: Performance Analysis - The SCHD has underperformed during the AI boom, with year-to-date total returns being near flat or slightly positive, while tech-focused funds like the Invesco QQQ Trust have seen stronger gains [7][8] - The ETF's portfolio is heavily weighted towards stable dividend payers in sectors such as energy (19%), consumer discretionary (18%), and healthcare (16%), with limited exposure to high-growth AI leaders [6][8] Group 3: Market Dynamics - The AI surge has concentrated market gains among a few mega-cap tech stocks, which prioritize reinvesting profits into growth rather than paying dividends, thus limiting their representation in SCHD's portfolio [5] - The equity risk premium has approached zero in 2025, indicating potential overvaluation reminiscent of the dot-com era [8]

Core Insights - The FDA has approved Amgen's UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive, marking it as the first and only CD19-Targeted B-Cell therapy for this condition [1][2] - UPLIZNA offers a new treatment option with the potential for long-term disease control, requiring only two doses per year after initial loading doses, which is a significant improvement over other therapies that require more frequent administration [1][6] Treatment Background - UPLIZNA is already FDA-approved for neuromyelitis optica spectrum disorder (NMOSD) and IgG4-related disease (IgG4-RD), showcasing its effectiveness in B cell depletion for immune-mediated disorders [2][5] - The approval reflects a growing body of evidence supporting B cell-driven autoimmune mechanisms in myasthenia gravis, positioning UPLIZNA as a strong therapeutic candidate [2][11] Clinical Impact - Clinical trials for UPLIZNA in gMG demonstrated significant improvements in MG-ADL and QMG functional scores, reduced frequency and severity of exacerbations, and early onset of sustained benefits [8][9] - The safety profile of UPLIZNA is consistent with prior indications, providing reassurance for its use in treating gMG [8][11] Research and Development - The Muscular Dystrophy Association (MDA) has invested over $57 million in myasthenia gravis research since its founding, with recent investments exceeding $400,000 from 2020 to 2025 [12] - MDA's commitment includes supporting active research grants and providing comprehensive patient support through a network of over 150 Care Centers [12] Community and Advocacy - The MDA Care Center Network plays a crucial role in clinical trials, multidisciplinary care, and patient support across the United States, enhancing access to the latest clinical information and treatment options [3][12] - The approval of UPLIZNA is seen as a significant advancement for the gMG community, providing renewed hope and more choices for patients and families [4][11]

Core Viewpoint - Amgen's drug Uplizna has received FDA approval for treating generalized myasthenia gravis (gMG) in adults with specific antibody profiles, marking a significant advancement in the treatment landscape for this rare disease [1][10]. Group 1: Drug Approval and Efficacy - Uplizna is the first CD19-targeted B-cell therapy approved for gMG, providing a twice-yearly dosing option, which is a notable advantage over existing therapies that require more frequent administration [2][10]. - The FDA's approval is based on data from the phase III MINT study, demonstrating strong efficacy in gMG patients [3][10]. - This approval represents the second for Uplizna in 2023 and its third overall in the U.S., following approvals for immunoglobulin G4-related disease and neuromyelitis optica spectrum disorder [4][10]. Group 2: Market Position and Competition - Uplizna enters a competitive market for gMG therapies, competing with argenx's Vyvgart/Vyvgart Hytrulo, J&J's Imaavy, and UCB's Rystiggo [6][10]. - While Uplizna, Vyvgart/Vyvgart Hytrulo, and Rystiggo are approved for adults, Imaavy has a broader age eligibility, being approved for patients aged 12 years and older [8]. Group 3: Financial Performance and Valuation - Amgen's shares have outperformed the industry year to date, indicating strong market performance [9][10]. - The company is currently trading at a price/earnings (P/E) ratio of 14.67, which is below the industry average of 16.59, suggesting a potential undervaluation [12]. - Earnings per share (EPS) estimates for 2025 and 2026 have increased in the past 30 days, reflecting positive market sentiment [13].

Core Insights - Amgen has received FDA approval for UPLIZNA (inebilizumab-cdon) as the first CD19-targeted B cell therapy for treating generalized myasthenia gravis (gMG) in adults who are positive for anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibodies, offering a new treatment option with the potential for long-term disease control through biannual dosing after initial loading doses [1][7][20] Group 1: Treatment Efficacy and Approval - The approval is based on the Myasthenia Gravis Inebilizumab Trial (MINT), which is the largest Phase 3 study for gMG, demonstrating significant efficacy in reducing symptoms and steroid dependency among patients [4][5] - At Week 26, UPLIZNA showed a 1.9-point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared to placebo, with a statistically significant p-value of <0.0001 [6][11] - The trial included 238 adults, with 87.4% of UPLIZNA patients reducing their steroid dose to 5 mg or less per day by Week 26, indicating a reduction in steroid dependency [4][14] Group 2: Patient Impact and Market Potential - UPLIZNA offers a convenient dosing schedule of twice a year, which is expected to improve patient adherence and quality of life by providing six months of treatment-free time between doses [2][7] - The prevalence of gMG in the U.S. is estimated to be between 80,000 and 100,000 patients, with a growing global incidence, highlighting a significant market opportunity for UPLIZNA [3][17] - This approval marks the third indication for UPLIZNA, previously approved for anti-AQP4 antibody positive neuromyelitis optica spectrum disorder (NMOSD) and Immunoglobulin G4-related disease (IgG4-RD), showcasing the drug's versatility [7][20] Group 3: Safety and Adverse Reactions - Common adverse reactions reported in gMG patients include headache and infusion-related reactions, with a noted incidence of 10.1% during the clinical trials [8][30] - Amgen emphasizes its commitment to patient support and access to UPLIZNA, indicating a proactive approach to managing treatment-related challenges [8][39]

Core Insights - Zealand Pharma has announced a five-year strategy called "Metabolic Frontier 2030" to enhance its anti-obesity portfolio amid increasing competition in the market [2][3] - The company aims for five drug launches, at least ten clinical pipeline programs, and industry-leading cycle times by 2030 [2] - Zealand's shares have dropped 29% year-to-date, reflecting investor concerns about market fragmentation and competition [2] Company Strategy - The strategy will leverage strategic partnerships, accelerated drug development, and expanded research capabilities to create a valuable metabolic health pipeline [3] - Zealand Pharma is focusing on candidates with greater potential for clinical differentiation, having paused development of a dual agonist due to market saturation [8] Drug Development - One of Zealand's promising drugs, petrelintide, targets the pancreatic amylin hormone and has shown moderate side effects in early-stage trials [4] - Mid-stage data for petrelintide is expected early next year, while data for its dual GLP-1 agonist, survodutide, will be available throughout 2026 [4] Market Dynamics - Novo Nordisk and Eli Lilly currently dominate the weight loss drug market, with analysts predicting the market could reach $150 billion annually by the start of the next decade [5] - Eli Lilly has gained investor favor due to its effective weight loss drugs and diverse portfolio, while Novo Nordisk is experiencing significant stock declines [6][7] Competitive Landscape - Big Pharma companies like AstraZeneca, Amgen, and Pfizer are also entering the obesity drug market, aiming to capture market share from Lilly and Novo [9] - Analysts believe that while Lilly may hold over 50% of the global market share, this will stabilize as competitors launch next-generation drugs [10] Partnerships and Research - Zealand Pharma has entered an agreement with OTR Therapeutics to develop oral small molecule treatments for metabolic diseases, involving an upfront payment of $20 million and potential milestones worth up to $2.5 billion [11] - The company plans to open a new research site in Boston, combining its peptide drug expertise with AI-driven drug discovery [12]

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Core Points - Amgen's Board of Directors declared a dividend of $2.52 per share for Q1 2026, payable on March 6, 2026, to stockholders of record as of February 13, 2026 [1] - Amgen is a leader in biotechnology, focusing on innovative medicines for serious diseases, with a strong pipeline targeting cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [2] - The company has received multiple accolades, including being named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes [3] Company Overview - Amgen has over 40 years of experience in the biotechnology industry and continues to leverage technology and human genetic data for innovation [2] - The company is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, highlighting its significance in the market [3] Contact Information - For further inquiries, Amgen's media contact is Elissa Snook at 609-251-1407, and investor contact is Casey Capparelli at 805-447-1746 [8]

Core Insights - Teva Pharmaceutical Industries Limited's stock has shown bullish momentum, trading above its 50-day and 200-day simple moving averages since late October, with a golden cross achieved in mid-September, indicating potential for a sustained upward trend [1][2][7] Stock Performance and Drivers - The 50-day SMA remains above the 200-day SMA, signaling positive future gains for the stock [2] - A significant factor contributing to Teva's stock performance was the conclusion of pricing negotiations under the Inflation Reduction Act for its key drug, Austedo, which is set for Medicare price setting starting in 2027. Teva raised its 2025 sales expectations for Austedo and maintains a revenue target of over $2.5 billion by 2027, with projections to exceed $3 billion by 2030 [2][6] Product Performance - Teva's newest branded drugs, including Austedo, Ajovy, and Uzedy, have collectively seen a 33% year-over-year sales increase, reaching $800 million in the third quarter [5] - Austedo sales rose 33% in the first nine months of 2025, with expectations for annual revenues exceeding $2.5 billion by 2027 and over $3 billion by 2030. The launch of Austedo XR, a new formulation, is expected to further boost sales [6] - Ajovy sales increased by 27% in the first nine months of 2025, with anticipated growth from patient expansion and international launches [8] - Uzedy, launched in May 2023, achieved sales of approximately $136 million in the first nine months of 2025, with total sales expected between $190 million and $200 million for the year [9] Pipeline and Future Growth - Teva's branded pipeline includes promising products like olanzapine and duvakitug, with ongoing phase III studies for duvakitug in collaboration with Sanofi [10] - The company anticipates generating over $5 billion in revenues from its branded products by 2030 [11] - Teva's generics and biosimilars pipeline is strengthening, with successful launches of several high-value complex generics and biosimilars [12][13] Market Position and Valuation - Teva's U.S. generics/biosimilars business showed a 15% increase in 2024, although sales were nearly flat in the first nine months of 2025 due to competitive pressures [15] - The stock has risen 28.6% year-to-date, outperforming the industry average of 28.2%, and is trading at a forward price/earnings ratio of 10.39, lower than the industry average of 14.37 [20][23] Financial Outlook - The Zacks Consensus Estimate for earnings has increased from $2.55 to $2.61 per share for 2025, with stability at $2.73 for 2026 [26] - Despite headwinds, Teva's newer drugs are driving top-line growth, and the company is focused on cost savings and margin improvements, targeting an adjusted operating margin of 30% by 2027 [29][30]