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Press Release: Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy
Globenewswire· 2025-06-30 05:00
Core Insights - The Japanese Ministry of Health, Labour and Welfare has granted orphan drug designation to riliprubart for chronic inflammatory demyelinating polyneuropathy (CIDP), highlighting its potential to address significant unmet medical needs in this rare neurological condition [1][5] - Approximately 30% of CIDP patients do not respond to standard therapies, and many who do experience incomplete responses, indicating a substantial market opportunity for riliprubart [3][5] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging a deep understanding of the immune system [4] - The company is currently conducting two phase 3 studies for riliprubart, aiming to establish it as a first-in-class treatment for CIDP [5] Product Development - Riliprubart (SAR445088) is a humanized IgG4 monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway, potentially reducing inflammation and preventing nerve damage in CIDP [3] - Long-term efficacy and safety data from a phase 2 study of riliprubart were presented, suggesting sustained benefits for CIDP patients [2] Market Context - There are approximately 4,000 diagnosed CIDP patients in Japan, with a significant portion experiencing debilitating symptoms despite existing therapies [1][3] - The orphan drug designation in Japan adds to similar recognitions in the US and Europe, reinforcing the global regulatory acknowledgment of riliprubart's potential [5]
Banco Santander (SAN) is a Top Dividend Stock Right Now: Should You Buy?
ZACKS· 2025-06-25 16:51
Group 1: Company Overview - Banco Santander (SAN) is based in Madrid and operates in the Finance sector, with shares experiencing a price change of 81.36% this year [3] - The company currently pays a dividend of $0.09 per share, resulting in a dividend yield of 2.19%, which is lower than the Banks - Foreign industry's yield of 3.4% and the S&P 500's yield of 1.6% [3] Group 2: Dividend Performance - Banco Santander's annualized dividend of $0.18 has increased by 20% from the previous year, with an average annual increase of 17.90% over the last 5 years [4] - The current payout ratio is 18%, indicating that the company paid out 18% of its trailing 12-month earnings per share as dividends [4] Group 3: Earnings Growth - The Zacks Consensus Estimate for Banco Santander's earnings in 2025 is $0.97 per share, with an expected increase of 16.87% from the previous year [5] Group 4: Investment Considerations - Dividends are favored by investors for various reasons, including tax advantages and risk reduction, although not all companies provide quarterly payouts [6] - Banco Santander is considered a compelling investment opportunity due to its strong dividend performance and current Zacks Rank of 3 (Hold) [7]
Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Globenewswire· 2025-06-25 05:00
Core Insights - The FDA has granted orphan drug designation to riliprubart for treating antibody-mediated rejection (AMR) in solid organ transplantation, highlighting a significant unmet need in transplant medicine [1][2] - Riliprubart is a first-in-class IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway [3] - Sanofi is conducting multiple clinical studies for riliprubart, including a phase 2 study for kidney transplant recipients and two phase 3 studies for chronic inflammatory demyelinating polyneuropathy [2][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging deep understanding of the immune system [5] - The company is committed to addressing urgent healthcare challenges and has a robust pipeline aimed at high unmet medical needs [5] Industry Context - Antibody-mediated rejection is a serious complication post-organ transplantation, where the recipient's immune system attacks the transplanted organ, leading to potential organ failure if untreated [4] - The orphan drug designation reflects the rarity of the condition, affecting fewer than 200,000 people in the US, and underscores the importance of developing targeted therapies in this area [1][4]
3 International Bank Stocks With Strong Dividends
MarketBeat· 2025-06-24 12:33
Core Viewpoint - The U.S. stock market is facing challenges near all-time highs, leading investors to consider international banking stocks as a viable option for capital preservation and income generation amidst weakening economic data and global conflicts [1][5]. Group 1: Investment Landscape - U.S. investors have historically benefited from a domestic bias, but recent performance indicates that European stocks have outperformed U.S. stocks since the end of the 2022 bear market [2][3]. - The S&P 500 has been one of the worst-performing indices in the developed world since the start of 2025, prompting a reevaluation of investment strategies [3]. Group 2: Reasons for Shifting Investment Attitudes - Differing macroeconomic environments are influencing investment decisions, with the Federal Reserve maintaining rates while the European Central Bank is cutting rates, potentially leading to stifled growth in the U.S. [8]. - The U.S. dollar is losing its status as a safe haven, as evidenced by its depreciation during market turmoil, which benefits international banks with foreign currency revenue [8]. - Attractive valuations of international banks compared to U.S. peers are drawing investor interest, as the S&P 500 trades at around 23 times 2025 earnings, while European and Canadian banks are trading at lower multiples [8]. Group 3: International Bank Stocks - **Royal Bank of Canada (RY)**: Reported a 42% year-over-year EPS growth and record net income of $5.1 billion, driven by the acquisition of HSBC Bank Canada, with a dividend yield of 3.52% and a P/E ratio of 14.13 [11][12]. - **Banco Santander (SAN)**: Achieved record profits with a 19% increase in income and a 26% increase in EPS year-over-year, trading at a P/E ratio of 9.20 and a dividend yield of 2.25% [13][14]. - **NatWest Group (NWG)**: Increased income by nearly 16% year-over-year, with a dividend yield of 5.65% and a P/E ratio of 9.14, supported by strategic acquisitions and partnerships to enhance market share and efficiency [17][18].
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
Globenewswire· 2025-06-23 05:00
Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sarclisa in combination with VRd for the treatment of transplant-eligible newly diagnosed multiple myeloma (NDMM) patients, indicating significant progress in addressing unmet patient needs in this area [1][2]. Group 1: Study and Approval Details - The positive CHMP opinion is based on results from the GMMG-HD7 study, which demonstrated a deep and rapid response in transplant-eligible NDMM patients using an anti-CD38-based induction regimen [2][3]. - GMMG-HD7 is the first phase 3 study to show a higher proportion of patients achieving minimal residual disease (MRD) negativity and significant progression-free survival (PFS) benefits post-induction [3][4]. - The study enrolled 662 patients across 67 sites in Germany, with participants receiving three 42-day cycles of VRd, and Sarclisa added to one arm of the study [6][7]. Group 2: Clinical Evidence and Outcomes - The results indicated the highest post-induction and post-transplant MRD negativity rates for any CD38 monoclonal antibody using VRd as a backbone in transplant-eligible NDMM [4][8]. - The primary endpoints of the study included MRD negativity following induction therapy and PFS after post-transplant randomization, with the latter expected to be available later [8][9]. - Secondary endpoints included rates of complete response after induction, overall survival, and safety, with MRD negativity assessed by next-generation flow cytometry [9]. Group 3: Current Approvals and Future Potential - Sarclisa is currently approved in the EU for three indications across different lines of therapy for adult patients with relapsed and/or refractory multiple myeloma and NDMM who are not eligible for transplant [5][10]. - If approved, the new regimen would represent the fourth indication in the EU and the second in the front-line setting globally, enhancing treatment options for transplant-eligible patients [8][10].
Press Release: Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
Globenewswire· 2025-06-20 05:00
Core Viewpoint - Dupixent (dupilumab) has been approved by the US FDA as the only targeted treatment for adult patients with bullous pemphigoid (BP), a chronic skin disease primarily affecting the elderly [1][4][5]. Group 1: Disease Overview - Bullous pemphigoid primarily affects elderly patients and is characterized by intense itching, painful blisters, and skin lesions, leading to increased infection risk and impaired daily functioning [2][3]. - Current treatment options for BP are limited and often involve immunosuppressive therapies that can exacerbate the disease burden [2][3]. Group 2: Dupixent Approval and Efficacy - The FDA approval of Dupixent is based on the pivotal ADEPT phase 2/3 study, which demonstrated significant improvements in sustained disease remission and itch reduction compared to placebo [4][6][8]. - In the study, 18.3% of patients on Dupixent achieved sustained disease remission at 36 weeks compared to 6.1% for placebo, with a 12.2% difference [6][9]. - Additionally, 38.3% of patients on Dupixent experienced clinically meaningful itch reduction compared to 10.5% for placebo [6]. Group 3: Treatment Protocol and Safety - Dupixent is administered as a subcutaneous injection at a dosage of 300 mg every two weeks after an initial loading dose, in conjunction with a tapering course of oral corticosteroids [10][11]. - The most common adverse events (≥2%) observed in patients treated with Dupixent included arthralgia, conjunctivitis, and herpes viral infections [4][6]. Group 4: Broader Implications and Future Directions - Dupixent is now approved for treating eight distinct diseases associated with type 2 inflammation, indicating its potential to transform treatment paradigms for various conditions [5][7]. - The approval reinforces Dupixent's safety profile across a broad age range, with ongoing regulatory applications in other regions, including the EU, Japan, and China [7][13].
Press release: Sanofi successfully prices €1.5 billion bond issue
Globenewswire· 2025-06-17 11:40
Core Viewpoint - Sanofi has successfully priced a €1.5 billion bond issue, which will be utilized for general corporate purposes [1]. Group 1: Bond Issue Details - The bond issue consists of two tranches, each amounting to €750 million [7]. - The first tranche is due in June 2029 with an annual interest rate of 2.625% [7]. - The second tranche is due in June 2032 with an annual interest rate of 3.000% [7]. Group 2: Transaction Management - The transaction was led by Citigroup and RBC Capital Markets as Global Coordinators [2]. - Credit Agricole CIB, HSBC, and Societe Generale acted as Joint Lead Managers for the bond issue [2]. Group 3: Company Overview - Sanofi is an R&D driven, AI-powered biopharma company focused on improving lives through innovative medicines and vaccines [3]. - The company aims to address urgent healthcare, environmental, and societal challenges [3]. - Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY [3].
Press Release: EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study
Globenewswire· 2025-06-15 15:22
Core Insights - Dupixent (dupilumab) demonstrated superiority over Xolair (omalizumab) in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in patients with coexisting asthma, as shown in the EVEREST phase 4 study [1][4][6] Group 1: Study Overview - The EVEREST study involved 360 adults with severe, uncontrolled CRSwNP and coexisting asthma, randomized to receive either Dupixent 300 mg every two weeks or omalizumab based on weight and IgE levels [2][6] - The study assessed various primary and secondary endpoints over a 24-week period, with results presented at the EAACI Annual Congress [1][6] Group 2: Efficacy Results - Dupixent showed a 1.60-point superior reduction in nasal polyp size (p<0.0001) and an 8.0-point superior improvement in the ability to identify different smells (p<0.0001) compared to omalizumab [5] - Other significant improvements included a 0.58-point reduction in nasal congestion (p<0.0001), a 1.74-point reduction in symptom severity (p<0.0001), and a 12.7-point difference in health-related quality of life (p<0.0001) [5] Group 3: Safety Profile - The safety profile of Dupixent was consistent with its known profile, with adverse events reported in 64% of Dupixent patients and 67% of omalizumab patients [3][4] - Serious adverse events occurred in 2% of Dupixent patients compared to 4% for omalizumab, indicating a generally similar safety profile [3][4] Group 4: Mechanism of Action - Dupixent targets interleukin-4 (IL-4) and interleukin-13 (IL-13), key drivers of type 2 inflammation, reinforcing its efficacy in treating both upper and lower respiratory diseases [4][8] Group 5: Regulatory Status - Dupixent has received regulatory approvals in over 60 countries for various indications, including CRSwNP, asthma, and other allergic conditions, with more than one million patients treated globally [9][10]
Sanofi: Information concerning the total number of voting rights and shares - May 2025
Globenewswire· 2025-06-09 21:10
Core Points - The document provides information regarding the total number of voting rights and shares for Sanofi as of May 31, 2025 [1] - Sanofi has a registered share capital of €2,452,461,656 and is registered at the Paris Commercial and Companies Registry [1] Summary by Category Voting Rights - Total number of issued shares is 1,227,755,892 [1] - The number of real voting rights, excluding treasury shares, is 1,351,729,644 [1] - The theoretical number of voting rights, including treasury shares, is 1,361,952,180 [1] Company Information - Sanofi is a French société anonyme with its registered office located at 46, avenue de la Grande Armée, 75017 Paris, France [1] - The company is registered under number 395 030 844 [1]
This is Why Banco Santander (SAN) is a Great Dividend Stock
ZACKS· 2025-06-09 16:50
Company Overview - Banco Santander (SAN) is headquartered in Madrid and operates in the Finance sector, with a stock price change of 76.32% since the beginning of the year [3] - The company currently pays a dividend of $0.09 per share, resulting in a dividend yield of 2.25%, which is lower than the Banks - Foreign industry's yield of 3.7% and the S&P 500's yield of 1.53% [3] Dividend Performance - The annualized dividend of Banco Santander is currently $0.18, reflecting a 20% increase from the previous year [4] - Over the past five years, the company has increased its dividend four times on a year-over-year basis, averaging an annual increase of 17.90% [4] - The current payout ratio is 18%, indicating that the company pays out 18% of its trailing 12-month earnings per share as dividends [4] Earnings Growth - The Zacks Consensus Estimate for Banco Santander's earnings per share for 2025 is $0.96, representing a year-over-year growth rate of 15.66% [5] Investment Considerations - Dividends are favored by investors for various reasons, including improving stock investing profits and providing tax advantages [6] - It is noted that tech start-ups and high-growth businesses rarely offer dividends, while larger, established companies are more likely to do so [7] - Banco Santander is considered a compelling investment opportunity due to its strong dividend profile and current Zacks Rank of 3 (Hold) [7]