Core Insights - Novartis' ianalumab received Breakthrough Therapy designation from the FDA for treating adult patients with Sjogren's disease, a chronic autoimmune disorder [1][6] - Ianalumab is a monoclonal antibody that targets the BAFF receptor to deplete B-cells and inhibit their activation and survival [1] - The Breakthrough Therapy designation is based on positive results from phase III NEPTUNUS-1 and NEPTUNUS-2 studies, which showed significant improvements in disease activity compared to placebo [2][6] Clinical Data - The NEPTUNUS studies demonstrated clinically meaningful reductions in ESSDAI scores, a measure of systemic disease activity in Sjogren's syndrome [2] - Ianalumab exhibited a favorable safety profile, with tolerable side effects reported [3] - If approved, ianalumab would be the first targeted therapy for Sjogren's disease [3] Regulatory and Market Outlook - Novartis plans to submit regulatory applications for ianalumab to global health authorities, including the FDA, starting in early 2026 [3][6] - Over the past year, Novartis shares have increased by 48%, outperforming the industry average rise of 24.1% [3] Pipeline Expansion - Ianalumab is also being investigated for other B-cell-driven autoimmune diseases, including immune thrombocytopenia, systemic lupus erythematosus, and lupus nephritis [8] - Positive results from the phase III VAYHIT2 study indicated that ianalumab combined with eltrombopag extended disease control in ITP patients by 45% [9] - In the VAYHIT2 study, 62% of patients treated with ianalumab achieved sustained platelet response compared to 39% in the placebo group [10]

Core Insights - HUTCHMED (China) Limited announced positive data from the Phase 3 registration part of the ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) [1][4] Clinical Trial Results - The ESLIM-02 trial met its primary endpoint of durable hemoglobin response rate between weeks 5 to 24 of treatment [2] - The overall response rate was 43.8% in the first 8 weeks and 66.7% during the 24 weeks of treatment, compared to 0% in the placebo group [4] - The study included patients who had relapsed or were refractory to at least one prior line of standard treatment [3] Disease Prevalence and Impact - The incidence of autoimmune hemolytic anemia (AIHA) is estimated at 0.8-3.0 per 100,000 adults annually, with a prevalence of 17 per 100,000 adults and a death rate of 8-11% [2] - wAIHA accounts for approximately 75-80% of all adult AIHA cases [2] Regulatory Plans - HUTCHMED plans to submit a New Drug Application for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026 [4] Competitive Landscape - Novartis AG reported results from the VAYHIT2 Phase 3 trial showing that ianalumab plus eltrombopag had a median time to treatment failure 2.8 times longer than placebo plus eltrombopag [6] - CRISPR Therapeutics AG initiated a Phase 1 trial of its allogeneic CAR T therapy in ITP and wAIHA [6] Other Developments - HUTCHMED initiated the Phase 3 part of a trial for a combination treatment for metastatic pancreatic ductal adenocarcinoma [7] - HUTCHMED shares increased by 5.09% to $14.45 during premarket trading [7]

Core Viewpoint - The article discusses the most profitable NYSE stocks to buy currently, emphasizing the importance of earnings estimates over traditional valuation methods in stock selection [1][2][4]. Group 1: Market Outlook - Daniel McCormack from Macquarie Asset Management predicts a solid growth year in 2026, estimating global growth at 3.5%, aligning with long-term averages [3]. - The US economy is expected to remain strong, with gradual recoveries in Europe and the UK, contributing to a constructive environment for asset prices [4]. Group 2: Methodology - The list of profitable NYSE stocks was created using stock screeners, focusing on those with the highest trailing twelve months (TTM) net income and net income margins [6]. - The final selection included 11 stocks with the highest number of hedge fund holders as of Q3 2025, sourced from Insider Monkey's database [6][7]. Group 3: Company Highlights - **Novartis AG (NYSE:NVS)**: - TTM Net Income: $14.39 billion, Net Income Margin: 25.53%, Hedge Fund Holders: 33 [9]. - HSBC raised the price target to $112 from $106 while maintaining a Reduce rating, indicating a positive outlook for the pharma sector [10]. - Novartis announced positive Phase III trial results for ianalumab, showing a 45% extension in disease control for patients with primary immune thrombocytopenia [10][11]. - **BlackRock, Inc. (NYSE:BLK)**: - TTM Net Income: $6.1 billion, Net Income Margin: 26.64%, Hedge Fund Holders: 63 [12]. - Barclays reduced its price target to $1,340 from $1,360 but maintained an Overweight rating, reflecting a constructive market outlook for 2026 [13]. - BofA raised the price target to $1,464 from $1,456, reaffirming a Buy rating, favoring alternative asset managers due to a stronger macro backdrop [15].

Core Insights - Novartis AG announced results from the VAYHIT2 Phase 3 trial of ianalumab plus eltrombopag for patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids [1][5] Group 1: Trial Results - Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, with a median time to treatment failure of 13.0 months compared to 4.7 months for placebo plus eltrombopag [2] - The sustained platelet count improvement rate at six months was significantly higher for ianalumab plus eltrombopag at 62% versus 39% for placebo plus eltrombopag [4] - Fatigue improvement was also noted, with a mean reduction of 7.7 points for ianalumab plus eltrombopag compared to 3.6 points for placebo plus eltrombopag [4] Group 2: Additional Insights - The estimated probability of being free from treatment failure at 12 months was 54% in the 9-mg group, 51% in the 3-mg group, and 30% in the placebo group [5] - Ianalumab is under investigation for other B-cell-driven autoimmune diseases, with ongoing Phase 3 trials in first-line ITP and in second and later lines of warm autoimmune hemolytic anemia, with results expected in 2026 [5] - Novartis stock increased by 1.46% to $132.07 at the time of publication [5]

Core Insights - Novartis announced positive results from the VAYHIT2 Phase III trial, showing that ianalumab plus eltrombopag significantly improved disease control in patients with primary immune thrombocytopenia (ITP) compared to placebo [1][6][8] Group 1: Trial Results - Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, with a median time to treatment failure of 13.0 months compared to 4.7 months for placebo plus eltrombopag [1][6] - 62% of patients receiving ianalumab plus eltrombopag achieved sustained platelet count improvement at six months, compared to 39% for placebo plus eltrombopag [3][5] - The trial demonstrated a mean reduction in fatigue of 7.7 points with ianalumab plus eltrombopag versus 3.6 points with placebo plus eltrombopag [3] Group 2: Mechanism and Administration - Ianalumab targets B cells through a dual mechanism, depleting B cells while blocking survival signals, which is crucial for managing ITP [4][9] - The treatment regimen consists of four once-monthly intravenous doses, potentially reducing the need for chronic therapy [6][8] Group 3: Safety and Tolerability - Ianalumab was well tolerated, with adverse events comparable to placebo, the most common being headache and infusion-related reactions [7] - Neutropenia occurred more frequently in the ianalumab groups but most cases resolved without treatment [7] Group 4: Future Plans - Novartis plans to submit VAYHIT2 data along with results from the ongoing first-line ITP trial, VAYHIT1, to health authorities in 2027 [6][8]