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Press Release: Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors
Globenewswire· 2025-03-28 20:07
Core Perspective - Qfitlia (fitusiran) has been approved by the US FDA as the first antithrombin-lowering therapy for the routine prophylaxis of hemophilia A and B, providing a significant advancement in treatment options for patients with or without inhibitors [1][10]. Company Insights - Sanofi emphasizes its commitment to innovation in the treatment of rare blood disorders, highlighting Qfitlia's potential to transform hemophilia care through effective bleed protection and reduced treatment burden [3]. - The company is launching HemAssist alongside Qfitlia to offer comprehensive patient support services, including insurance assistance and educational resources [9]. Industry Impact - Qfitlia's unique mechanism allows for the treatment of all types of hemophilia, including those with inhibitors, addressing significant unmet medical needs in the market [4]. - The ATLAS clinical development program has shown that Qfitlia can achieve a significant reduction in annualized bleeding rates (ABR) by 71% for patients without inhibitors and 73% for patients with inhibitors compared to traditional on-demand treatments [7][12]. Clinical Data - In the ATLAS studies, Qfitlia demonstrated low bleed rates with as few as six injections per year, with nearly half of patients experiencing one or fewer bleeds during the open-label extension study [7][12]. - The FDA has also approved the Siemens Healthineers' INNOVANCE Antithrombin assay as a companion diagnostic for Qfitlia, allowing for AT level measurement at no cost to patients [8].
Trump's tariffs push will hit the U.S. harder than Europe in the short term, Santander chair says
CNBC· 2025-03-27 13:04
watch nowThe White House's protectionist policies could hit the U.S. harder than Europe in the short term, Banco Santander's executive chair told CNBC on Thursday, as tariffs take a toll on domestic consumers."Tariffs [are] a tax. It's a tax on the consumer." Ana Botín said in an interview with CNBC's Karen Tso in Brussels on the sidelines of the 2025 IIF European Summit. "Ultimately, the economy will pay a price. There will be less growth and there will be more inflation, other things equal."President Dona ...
Press Release: Chlamydia vaccine candidate granted fast track designation by the US FDA
Globenewswire· 2025-03-26 06:00
Core Viewpoint - The US FDA has granted fast track designation to Sanofi's mRNA vaccine candidate aimed at preventing chlamydia infection, highlighting its potential to address a significant public health need [1][2]. Group 1: Vaccine Development - The chlamydia vaccine candidate is designed to protect against primary genital tract infection and reinfection by Chlamydia trachomatis, with a phase 1/2 clinical study planned to evaluate its immunogenicity and safety in adults aged 18 to 29 years [2][8]. - The development of this vaccine is part of the Translational Science Hub, a collaboration involving the Queensland Government, Griffith University, and the University of Queensland, connecting researchers in Australia with Sanofi scientists [5]. Group 2: Public Health Impact - Chlamydia is a common bacterial infection with serious long-term health consequences, including infertility and pregnancy complications, affecting 129 million adults globally in 2020, particularly among adolescents and young adults [3][4]. - Over 80% of chlamydia cases are asymptomatic, leading to untreated infections and unintentional transmission, underscoring the urgent need for a vaccine to prevent rising infection rates [4]. Group 3: Company Overview - Sanofi is an innovative global healthcare company focused on improving lives through scientific advancements, providing life-changing treatments and vaccines while emphasizing sustainability and social responsibility [6].
Press Release: Availability of the Q1 2025 Aide mémoire
Globenewswire· 2025-03-24 06:30
Availability of the Q1 2025 Aide mémoire Paris, France – March 24, 2025. Sanofi announced today that its Q1 2025 Aide mémoire is available on the "Investors" page of the company's website: First quarter 2025 (sanofi.com) As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's first quarter ...
Why You Shouldn't Bet Against Banco Santander (SAN) Stock
ZACKS· 2025-03-21 18:30
One stock that might be an intriguing choice for investors right now is Banco Santander (SAN) . This is because this security in the Banks - Foreign space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the Finance spac ...
Press Release: Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline
Globenewswire· 2025-03-20 06:00
Core Viewpoint - Sanofi has agreed to acquire Dren Bio's bispecific myeloid cell engager, DR-0201, which targets deep B-cell depletion, enhancing its immunology pipeline [1][6]. Company Overview - Sanofi is a global healthcare company focused on innovative treatments and vaccines, aiming to improve patient lives through scientific advancements [11]. - Dren Bio is a clinical-stage biopharmaceutical company developing first-in-class antibody therapeutics for cancer and autoimmune diseases [8]. Product Details - DR-0201 is a bispecific antibody that engages myeloid cells to induce deep B-cell depletion, showing promise in treating autoimmune diseases like lupus [2][5]. - The drug is currently undergoing evaluation in two ongoing phase 1 studies, demonstrating robust B-cell depletion in both pre-clinical and clinical settings [5]. Strategic Implications - The acquisition of DR-0201 is part of Sanofi's strategy to strengthen its position in immunology and address significant unmet medical needs in autoimmune diseases [3][4]. - Sanofi's investment includes an upfront payment of $600 million, with potential future payments of $1.3 billion based on development milestones [6][9]. Operational Aspects - Following the acquisition, Dren Bio will continue to operate independently, focusing on its pipeline of antibody therapeutics [7]. - The transaction is expected to close in Q2 2025, pending regulatory approvals [7].
Santander says 750 jobs at risk as it pursues UK branch closures
CNBC· 2025-03-19 08:28
The British unit of Spanish lender Banco Santander on Wednesday said 750 of its staff were at risk of redundancy as it targets 95 branch closures in the U.K.The decision is part of the bank's broader plans to update its presence from June 2025 and will bring Santander UK's network to 349 branches, including 290 that are full-service, 36 operating with reduced hours and 18 that are counter-free and five Work Cafes."Closing a branch is always a very difficult decision and we spend a great deal of time assessi ...
Press Release: Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD
Globenewswire· 2025-03-08 18:00
Core Insights - Dupixent (dupilumab) has shown positive results in a pivotal phase 2/3 study for treating moderate-to-severe bullous pemphigoid (BP), a chronic skin disease characterized by intense itch and blisters [2][3][6] - The study demonstrated that Dupixent significantly improved disease remission rates and reduced disease severity compared to placebo [6][7] Study Details - The ADEPT study enrolled 106 adults with moderate-to-severe BP, randomized to receive Dupixent 300 mg every two weeks or placebo, alongside standard-of-care oral corticosteroids [3][9] - Sustained disease remission was defined as complete clinical remission with no relapse and no rescue therapy use during the 36-week treatment period [10] Efficacy Results - 20% of Dupixent-treated patients achieved sustained disease remission at 36 weeks compared to 4% in the placebo group (p=0.0114) [7] - 40% of patients on Dupixent experienced a ≥90% reduction in disease severity compared to 10% for placebo (p=0.0003) [7] - Dupixent also led to a significant reduction in oral corticosteroid use, with an average reduction of 1678 mg in cumulative exposure (p=0.0220) [7] Safety Profile - Adverse event rates were similar between Dupixent (96%) and placebo (96%) groups, with no deaths reported in the Dupixent group [4] - Common adverse events associated with Dupixent included peripheral edema, arthralgia, and blurred vision [4] Regulatory Status - The FDA has accepted a supplemental biologics license application for Dupixent to treat BP, with a decision expected by June 20, 2025 [4][6] - Dupixent has received orphan drug designation for BP, indicating its potential as a treatment for a rare disease affecting fewer than 200,000 people in the US [4] Background on Bullous Pemphigoid - BP is a chronic, debilitating skin disease primarily affecting the elderly, characterized by intense itch and painful lesions [8] - Approximately 27,000 adults in the US suffer from uncontrolled BP despite systemic corticosteroid treatment [8] About Dupixent - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling pathways, targeting type 2 inflammation [11] - It has received regulatory approvals in over 60 countries for various indications, with more than one million patients treated globally [12]
Press release: Sanofi successfully prices EUR 1.5 billion of bond issue
Globenewswire· 2025-03-05 17:10
Sanofi successfully prices EUR 1.5 billion of bond issue Paris, March 5, 2025. Sanofi announces that it has successfully priced its offering of EUR 1.5 billion of notes across 2 tranches: €850 million floating rate notes, due March 2027, bearing interest at 3-month Euribor plus 0.300%€650 million fixed rate notes, due March 2031, bearing interest at an annual rate of 2.750%. The notes are being issued off the company's Euro Medium Term Note Program. Sanofi intends to use the net proceeds of the offering f ...
Banco Santander (Brasil) S.A.: NOTICE TO THE MARKET
Prnewswire· 2025-02-28 22:00
Group 1 - Banco Santander (Brasil) S.A. filed its Annual Report on Form 20-F for the year 2024 with the U.S. SEC and the Brazilian CVM on February 28, 2025 [1] - The 20-F report includes certifications under the U.S. Sarbanes-Oxley Act, confirming the effectiveness of Santander Brasil's internal controls and procedures [2] - Independent auditors PricewaterhouseCoopers Auditores Independentes Ltda. provided an audit opinion on the financial statements and internal controls as of December 31, 2024 [2] Group 2 - Shareholders of Santander Brasil can request a hard copy of the 20-F document, which includes complete audited financial statements, free of charge [3]