Fabhalta (iptacopan)

Search documents
Buy These 5 Low-Leverage Stocks Amid Fresh Iran-Israel War
ZACKS· 2025-06-16 13:56
Market Overview - All three major U.S. stock market indices fell by more than 1% on June 13 due to missile strikes between Israel and Iran, impacting global stock markets negatively [1] - Investors are concerned that these geopolitical tensions could lead to increased oil prices and upward pressure on global commodity prices [1] Investment Recommendations - Suggested low-leverage stocks for safeguarding portfolios during market turmoil include Novartis (NVS), The Ensign Group (ENSG), MasTec (MTZ), Bilibili (BILI), and Sterling Infrastructure, Inc. (STRL) [2][10] - These stocks are characterized by low leverage, making them potentially safer options for investors [2][10] Understanding Leverage - Leverage refers to the practice of borrowing capital for operations and expansion, typically through debt financing [4] - Excessive debt financing can lead to significant losses, hence the importance of selecting companies with low debt levels [5][6] Debt-to-Equity Ratio Analysis - The debt-to-equity ratio is a key metric indicating a company's financial risk, with a lower ratio reflecting better solvency [7] - High debt-to-equity ratios can turn favorable earnings into losses during economic downturns [8] Stock Selection Strategy - A prudent investment strategy involves choosing stocks with low debt-to-equity ratios to ensure steady returns [9] - Additional screening criteria include being less leveraged than industry peers, trading at a minimum price of $10, having substantial trading volume, and showing positive earnings growth expectations [12][13] Company Highlights - **Novartis (NVS)**: Reported a 7.1% improvement in 2025 sales estimates and has a long-term earnings growth rate of 7.9%, currently holding a Zacks Rank 2 [15][16] - **The Ensign Group (ENSG)**: Anticipates a 15% year-over-year sales improvement in 2025, with a long-term earnings growth rate of 15% and a Zacks Rank 2 [17][18] - **MasTec (MTZ)**: Achieved a 6% year-over-year revenue increase and expects an 11% sales improvement in 2025, with a significant earnings growth estimate of 53.7% [19] - **Bilibili (BILI)**: Experienced a 24% revenue increase year-over-year and anticipates an 11.3% sales improvement in 2025, with a Zacks Rank 2 [20] - **Sterling Infrastructure (STRL)**: Reported a 7% revenue increase and a 29% surge in adjusted earnings per share, with a long-term earnings growth rate of 15% [21][22]
Novartis' Fabhalta Delivers Hemoglobin Gains, Reduces Fatigue In Patients With Rare Blood Disorder
Benzinga· 2025-06-12 18:25
Core Insights - Novartis AG has released results from the APPULSE-PNH Phase 3B study, evaluating the efficacy and safety of Fabhalta (iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who switched from anti-C5 therapies [1][3] Group 1: Study Results - The study showed that after 24 weeks of treatment with Fabhalta, the average hemoglobin (Hb) level improved by 2.01 g/dL, with most patients achieving normal or near-normal levels [3][4] - 92.7% of patients achieved Hb levels ≥12g/dL, and no patients required transfusions during the study [4][5] - Patients reported clinically meaningful improvements in fatigue, reaching levels similar to the general population [4][5] Group 2: Treatment Context - PNH is a rare blood disorder characterized by the destruction of red blood cells (RBCs) due to an acquired mutation in hematopoietic stem cells [2][6] - Current anti-C5 therapies require intravenous infusions every two to eight weeks, which can take approximately four to five hours for treatment visits [6] Group 3: Future Presentations - Data from the APPULSE-PNH study will be presented at the European Hematology Association (EHA) Congress 2025, alongside longer-term data from the APPLY-PNH and APPOINT-PNH Phase 3 studies [5]
Novartis Fabhalta® shows statistically significant and clinically meaningful improvements in hemoglobin in new population of patients with PNH
Globenewswire· 2025-06-12 06:00
Core Insights - Novartis announced positive results from the APPULSE-PNH Phase IIIB study, demonstrating the efficacy and safety of Fabhalta (iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who switched from anti-C5 therapies [1][4][9] - The study showed an average improvement in hemoglobin (Hb) levels of 2.01 g/dL after 24 weeks of treatment, with 92.7% of patients achieving Hb levels ≥12 g/dL [1][2][7] - Fabhalta is the first and only oral monotherapy available for PNH treatment, providing a significant alternative to existing intravenous therapies [4][8][14] Group 1: Study Results - The APPULSE-PNH study involved 52 participants who received Fabhalta for 24 weeks, with no patients requiring transfusions or experiencing breakthrough hemolysis [9][10] - Patients reported clinically meaningful improvements in fatigue, with average FACIT-Fatigue score improvements of 4.88 points at Day 84 and 4.29 points at Day 168 [2][7] - The treatment maintained intravascular hemolysis control and resolved extravascular hemolysis, as indicated by lactate dehydrogenase levels and a reduction in absolute reticulocyte count [3] Group 2: Clinical Context - PNH is a rare, chronic blood disorder affecting approximately 10-20 people per million worldwide, often diagnosed in individuals aged 30-40 [5][6] - Current anti-C5 therapies, such as eculizumab and ravulizumab, do not fully address the needs of all PNH patients, leaving many anemic and dependent on blood transfusions [8] - The introduction of Fabhalta addresses these unmet needs by offering an oral treatment option that can improve hemoglobin levels without the need for transfusions [2][4][8] Group 3: Company Commitment - Novartis is committed to advancing research and innovation to improve the lives of patients with PNH, as highlighted by the positive data from the APPULSE-PNH study [4][18] - The company plans to present longer-term data from related Phase III studies at the European Hematology Association Congress 2025, reinforcing the efficacy and safety profile of Fabhalta [4][1] - Fabhalta has received regulatory approvals in the US and Europe for the treatment of adults with PNH, further establishing Novartis's position in the rare disease market [14][18]