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Press Release: Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
Globenewswire· 2025-10-17 11:05
Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Wayrilz (rilzabrutinib) for treating immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, with a final decision expected soon [1][2] Group 1: Product Information - Wayrilz is the first BTK inhibitor for ITP, addressing the root cause of the disease through multi-immune modulation [5][7] - The drug has already received approval in the US and the UAE, and is under regulatory review in China [3] - Wayrilz has received fast track and orphan drug designations in the US, EU, and Japan for ITP and other rare diseases [3] Group 2: Clinical Study - The positive CHMP opinion is based on the LUNA 3 phase 3 study, which demonstrated that Wayrilz met both primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms [2][4] - The LUNA 3 study involved a randomized, multicenter design, comparing Wayrilz to placebo over a treatment period of 12 to 24 weeks [4] Group 3: Disease Context - Immune thrombocytopenia (ITP) is characterized by low platelet counts (<100,000/μL), leading to various bleeding symptoms and risks, including potentially life-threatening episodes [8] - Patients with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment [8]
Press Release: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease
Globenewswire· 2025-10-17 11:00
Core Viewpoint - Sanofi received a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding the marketing authorization application for Rezurock (belumosudil) for treating chronic graft-versus-host disease (cGVHD) in adults and pediatric patients, and the company plans to seek a re-examination of this opinion [1][3]. Group 1: Product Information - Rezurock is a first-in-class selective ROCK2 inhibitor, currently approved in 20 countries, including the US, UK, and Canada, for patients aged 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy [4][5]. - Since its first approval in the US in July 2021, more than 17,000 patients with cGVHD worldwide have been prescribed Rezurock [4]. Group 2: Clinical Evidence - The efficacy and safety of Rezurock are supported by several clinical studies, including the randomized, multicenter ROCKstar phase 2 study, which demonstrated consistent efficacy and tolerability for patients with cGVHD, as well as durable clinical responses over a period of three years [3][4]. Group 3: Impact of cGVHD - cGVHD is a life-threatening complication affecting up to 50% of patients who undergo stem cell transplants, and it is a major cause of morbidity and late non-relapse mortality following such procedures [2][6].
Santander Merges Openbank With Consumer Finance Unit
PYMNTS.com· 2025-10-15 20:04
Core Insights - Santander's digital consumer banking unit Openbank is merging with its consumer finance business, aiming to enhance its market position in Europe and provide a wider range of products to customers [2][3] Company Overview - The merger will allow Santander to operate its European consumer finance businesses under the Openbank brand, strengthening its presence in key markets such as Germany [2] - Openbank currently operates in Spain, Germany, Portugal, and the Netherlands, with expansions into Mexico and the U.S. [3] - Santander Consumer Finance (SCF) operates in 18 countries, boasting an auto loan volume exceeding €140 billion in Europe [3] Strategic Goals - The merger is expected to create a more efficient and innovative digital-first bank by leveraging Openbank's technology and Santander's consumer finance expertise [3] - The combined entity will provide customers with access to a broader range of products through a unified digital platform, simplifying banking, lending, and payment solutions [4] Business Development - The management of Openbank and SCF has successfully driven new business through retail partnerships with major companies like Apple, Amazon, and Vodafone [4]
Nissan recalls 173K US vehicles over fuel pump issue that could stall engine
New York Post· 2025-10-15 20:04
Core Points - Nissan is recalling over 173,000 vehicles in the US due to a fuel pump issue that can lead to engine stalling and increased crash risk [1][3][4] - The recall affects specific models including the 2013-2021 NV200 Van, 2014-2017 and 2019 NV200 Taxi, and 2015-2018 Chevrolet City Express [1][3] - Approximately 4.7% of the recalled units, equating to about 8,145 vehicles, are estimated to have the defect [1] Technical Details - The issue arises from an incorrectly installed sensor harness that measures the fuel tank temperature, which may contact the fuel pump connector and cause wear [3][4] - This contact can lead to an electrical short, potentially resulting in a blown fuel pump fuse and unexpected engine stalling [4][6] - Drivers may notice an indicator light on the instrument cluster signaling a short circuit [6] Recall Process - Vehicle owners are advised to take their cars to a dealership for repairs, which may involve rerouting the sensor harness or replacing the fuel pump at no cost [8] - Notification letters to vehicle owners are expected to be sent by December 3, 2025 [8]
Santander announces merger of Openbank and Santander Consumer Finance
Yahoo Finance· 2025-10-15 15:16
Core Viewpoint - Banco Santander has announced the merger of Openbank and Santander Consumer Finance into a single legal entity under the Openbank brand, aiming to streamline its European consumer finance operations, starting with Germany [1][5]. Group 1: Merger Details - The merger is intended to simplify operations and provide competitive financing solutions for partners such as auto manufacturers, dealers, and merchants [2]. - Openbank is Santander's flagship brand for digital-first consumer banking, which will carry the endorsement "by Santander" to emphasize its global banking association [2]. - The merger will allow customers of both Openbank and SCF to access a comprehensive range of offerings through a unified digital platform, providing a single entry point for banking, lending, and payment solutions [4]. Group 2: Operational Scope - Santander Consumer Finance operates in 18 countries with a loan volume exceeding €140 billion, supporting around 16,000 new customers daily across Europe [3]. - Openbank currently operates in Spain, Germany, Portugal, the Netherlands, and has expanded to the US and Mexico [2]. - The combined management of Openbank and SCF has established partnerships with major retailers such as Apple, Amazon, and Vodafone [3]. Group 3: Service Offerings - Openbank provides various services, including an automated investment service known as Robo Advisor, which uses AI tools to offer target prices for European and US stocks [4]. - Openbank has recently introduced a cryptocurrency trading service, further diversifying its offerings [5]. Group 4: Strategic Initiatives - Santander is advancing its commitment to a data and AI-centric approach through collaboration with OpenAI, aiming to position itself as an "AI-native" bank [6].
Banco Santander (Brasil): A Lean Bank Playing It Safe
Seeking Alpha· 2025-10-15 13:40
Core Insights - The article emphasizes the importance of identifying undercovered stocks in Brazil and Latin America, suggesting that these often present the best investment opportunities [1]. Group 1: Company Insights - The analyst holds a long position in the shares of BSBR and ITUB, indicating a positive outlook on these companies [2]. - The analysis is based on personal opinions and does not reflect any business relationships with the mentioned companies [2]. Group 2: Industry Insights - The focus on Brazil and Latin America highlights the potential for growth in these emerging markets, which may be overlooked by mainstream investors [1].
Santander integrates Openbank, Santander Consumer Finance into one entity in Europe
Reuters· 2025-10-15 07:07
Core Insights - Santander is integrating its digital lender Openbank with Santander Consumer Finance (SCF) into a single entity to streamline operations in European consumer finance [1] Group 1 - The integration aims to enhance efficiency and improve customer experience across the European market [1] - This move reflects Santander's strategy to consolidate its digital and consumer finance operations [1] - The new entity will gradually operate under a unified brand, focusing on digital solutions for consumers [1]
KBRA Assigns Preliminary Ratings to Santander Mortgage Asset Receivable Trust 2025-CES1 (SAN 2025-CES1)
Businesswire· 2025-10-14 21:13
Core Insights - KBRA has assigned preliminary ratings to eight classes of mortgage-backed notes from Santander Mortgage Asset Receivable Trust 2025-CES1, a $289.3 million RMBS transaction sponsored by Santander Bank, N.A. and Canyon PS1-25 Holdings, LP [1] - The mortgage pool consists entirely of newly originated closed-end second lien mortgages, with an average seasoning of less than three months and a total of 3,741 loans originated by PennyMac Loan Services, LLC [1] - The collateral is characterized by fully amortizing, fixed-rate mortgages with varying terms: 10-year (0.4%), 15-year (0.6%), 20-year (78.5%), and 30-year (20.5%) [1] Rating Methodology - KBRA's rating approach includes loan-level analysis through its Residential Asset Loss Model (REALM), third-party loan file due diligence, cash flow modeling analysis, and reviews of key transaction parties [2] - The assessment also involves an evaluation of the transaction's legal structure and documentation, as detailed in KBRA's U.S. RMBS Rating Methodology [2]
Jim Cramer Says He Likes Banco Santander Very Much
Yahoo Finance· 2025-10-14 17:31
Group 1 - Banco Santander, S.A. is recognized as a leading bank in Europe, with positive remarks from Jim Cramer, who considers it his "favorite bank in Europe" [2] - The stock has shown significant growth, having doubled since the last meeting with the CEO, indicating strong market performance [1] - Cramer suggests a cautious approach to investing in Banco Santander, recommending to wait for a price drop to $9 before buying, despite its current good yield [2] Group 2 - The company provides a wide range of financial services, including banking, financing, investment, and insurance, catering to individuals, businesses, and public institutions [2] - There is a mention of potential investment opportunities in AI stocks that may offer greater upside potential compared to Banco Santander, highlighting a competitive landscape in the investment market [2]
Sanofi: Information concerning the total number of voting rights and shares - September 2025
Globenewswire· 2025-10-14 16:30
Core Points - The document provides information regarding the total number of voting rights and shares for Sanofi as of September 30, 2025 [1] - Sanofi has a registered share capital of €2,454,937,946 and is registered at the Paris Commercial and Companies Registry [1] Summary by Category - **Total Number of Shares**: As of September 30, 2025, Sanofi has issued a total of 1,227,469,992 shares [1] - **Voting Rights**: The theoretical number of voting rights, including treasury shares, is reported as 1,361,772,559 [1] - **Excluding Treasury Shares**: The number of real voting rights, excluding treasury shares, stands at 1,352,290,790 [1]