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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]
Press Release: Sanofi accelerates global shipping of Beyfortus to prepare healthcare providers months ahead of 2025-2026 RSV season
Globenewswire· 2025-06-09 05:00
Core Viewpoint - Sanofi is proactively shipping Beyfortus (nirsevimab) to ensure availability ahead of the 2025-2026 RSV season, responding to increasing demand and aiming to support healthcare providers effectively [1][2]. Group 1: Product Availability and Production - Sanofi, in collaboration with AstraZeneca, has tripled production capacity and doubled manufacturing sites since Beyfortus's launch in 2023, with current supply matching last year's total doses distributed [2]. - Advance shipments of Beyfortus are being made to ensure broad availability for the upcoming RSV season, which typically runs from November to March [1]. Group 2: Efficacy and Impact - Beyfortus has shown high, sustained efficacy in protecting infants from RSV, supported by over 40 real-world studies involving 250,000 immunized infants [3]. - The duration of protection for Beyfortus has been extended to six months in the EU, allowing for season-long protection for all infants, including those immunized just before the RSV season [4]. Group 3: Market Context and Health Implications - RSV is highly contagious, infecting two out of three infants in their first year and nearly all children by their second birthday, making it a leading cause of hospitalization among infants worldwide [5]. - Beyfortus is distinguished as the longest-acting monoclonal antibody for RSV prevention, designed to protect all infants regardless of health conditions or timing of birth [6].
金十整理:机构前瞻欧洲央行利率决议——宽松周期尾声渐进,欧央行将何时“收手”?
news flash· 2025-06-05 07:57
Group 1 - Goldman Sachs expects a 25 basis point rate cut, maintaining GDP forecasts for this year while lowering next year's GDP forecast and significantly reducing inflation predictions [1] - UBS anticipates a 25 basis point rate cut, with the last cut expected in July, bringing rates down to 1.75%, and a potential rate hike by the end of 2026 to address inflation risks [1] - Bank of America predicts a 25 basis point rate cut, noting that the market has already priced in the recent ECB rate cut, which is unlikely to have a significant impact on the euro [1] Group 2 - Nomura Securities forecasts a 25 basis point rate cut, with further cuts expected in July and September until rates reach 1.50%, while adjusting GDP and inflation predictions [1][2] - Deutsche Bank expects a 25 basis point rate cut, suggesting that the terminal rate for the easing cycle should remain at 1.50%, with a potential rate hike to 1.75% by the end of 2026 [2] - Pacific Investment Management Company anticipates a 25 basis point rate cut, indicating that the ECB is entering the final phase of its easing cycle, with current market pricing around 1.7% appearing reasonable [3]
Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
Globenewswire· 2025-06-03 12:26
Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]
Press Release: Rilzabrutinib granted orphan drug designation in the US for sickle cell disease
Globenewswire· 2025-06-03 05:00
Core Viewpoint - The FDA has granted orphan drug designation to rilzabrutinib for sickle cell disease, highlighting its potential to address unmet medical needs in rare diseases [1][2]. Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [7]. Product Information - Rilzabrutinib is a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that aims to restore immune balance through multi-immune modulation [5]. - The drug has received multiple orphan drug designations, including for immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), and IgG4-related disease (IgG4-RD) [2][8]. Disease Context - Sickle cell disease affects over 100,000 people in the US, predominantly impacting African American and Hispanic populations, leading to severe pain and reduced life expectancy [6]. - The disease is characterized by misshapen red blood cells that block blood flow, causing various health complications [6]. Regulatory Status - Rilzabrutinib is currently under regulatory review in the US, EU, and China for its potential use in ITP, with a target action date for FDA decision set for August 29, 2025 [3][8].
Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials
Globenewswire· 2025-05-30 05:00
Core Insights - The AERIFY-1 trial demonstrated a statistically significant reduction of 27% in moderate or severe exacerbations in former smokers with COPD compared to placebo at week 52, indicating a clinically meaningful benefit [1][2] - The AERIFY-2 trial did not meet its primary endpoint, although some benefits were observed earlier in the trial [1][3] - Itepekimab was generally well tolerated across both trials, with safety profiles consistent with previous clinical studies [1][5] Trial Details - AERIFY-1 involved 375 patients receiving itepekimab every two weeks, 377 every four weeks, and 375 receiving placebo, while AERIFY-2 included 326 patients every two weeks, 303 every four weeks, and 324 receiving placebo [2][10] - The primary endpoint for both trials was the reduction in the annualized rate of acute moderate or severe COPD exacerbations [12] Efficacy Results - In AERIFY-1, the reduction in exacerbations was 30% at week 24 and 27% at week 52 for the every-two-week group, and 34% at week 24 and 21% at week 52 for the every-four-week group [3] - In AERIFY-2, the reductions were 18% at week 24 and only 2% at week 52 for the every-two-week group, and 21% at week 24 and 12% at week 52 for the every-four-week group [3] Safety Profile - Adverse events (AEs) were comparable between treatment and placebo groups, with AEs reported at 67% and 68% for the every-two-week and every-four-week groups in AERIFY-1, respectively, compared to 68% for placebo [5] - Serious infections occurred in 7% of patients in both itepekimab arms in AERIFY-1, compared to 10% for placebo [5] Future Directions - Regeneron and Sanofi are reviewing the trial data and will discuss next steps with regulatory authorities [1][7] - Itepekimab is also being evaluated in other clinical trials for conditions such as chronic rhinosinusitis and non-cystic fibrosis bronchiectasis [8][15]