Study Results - The IRAKLIA phase 3 study demonstrated that the subcutaneous (SC) formulation of Sarclisa, administered via an on-body delivery system (OBDS) in combination with pomalidomide and dexamethasone (Pd), met its co-primary endpoints of non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous (IV) Sarclisa in patients with relapsed or refractory multiple myeloma (R/R MM) [1] - Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion reactions, and C trough at cycle 2, were also achieved [1] - The study enrolled 531 patients across 252 global sites, with patients randomized to receive either SC or IV Sarclisa in combination with Pd for 28-day cycles until disease progression or other discontinuation criteria were met [4] Subcutaneous Formulation and OBDS - The SC formulation of Sarclisa, delivered via the enFuse OBDS, represents a potential new administration option for patients, offering comparable efficacy and safety to the IV formulation [2] - The enFuse OBDS, developed by Enable Injections, is designed to administer high-volume medicines subcutaneously through an automated drug delivery technology, featuring a hidden and retractable needle that is thinner than commonly used SC injection needles [2][7] - The IRAKLIA study is the first global phase 3 study to evaluate the SC administration of a cancer treatment via an OBDS, aiming to improve the patient experience and reduce time spent in healthcare facilities [5] Regulatory and Clinical Development - Regulatory submissions for the SC formulation of Sarclisa are planned in the US and EU during the first half of 2025 [3] - Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing, with the safety and efficacy of the SC formulation and enFuse device yet to be evaluated by regulatory authorities outside of their approved indications [3][8] About Sarclisa - Sarclisa (isatuximab) is a CD38 monoclonal antibody that targets MM cells through multiple mechanisms of action, including apoptosis and immunomodulatory activity [8] - Currently approved in more than 50 countries, Sarclisa is indicated for the treatment of R/R MM in combination with Pd or carfilzomib and dexamethasone, and as a front-line treatment option for newly diagnosed MM in combination with VRd [8] Sanofi's Strategic Focus - Sanofi is committed to advancing oncology innovation, with a focus on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas, as well as gastrointestinal and lung cancers [9] - The company continues to advance Sarclisa as part of a patient-centric clinical development program, with several phase 2 and phase 3 studies across the MM treatment continuum [8][9]

Duvakitug positive phase 2b results demonstrate best-in-class potential in ulcerative colitis and Crohn’s disease Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibodySanofi and Teva plan to initiate phase 3 development in IBD, pending regulatory discussionsProgram underscores Sanofi's Immunology leadership ambitio ...

Availability of the Q4 2024 Aide-mémoire Paris, France – December 17, 2024. Sanofi announced today that its Q4 2024 Aide-mémoire is available on the "Investors" page of the company's website: Fourth quarter & full year 2024 results (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. ...

Santander’s fully digital bank, Openbank, launched in Mexico on Tuesday (Nov. 19).The Openbank Mexico website and app are now operating, promising a fully digital bank, no minimum balances, no fees and competitive interest rates, Openbank said in a Tuesday press release.Customers can also access 24/7 telephone support and all 10,000 Santander Mexico ATMs, according to the release.“Openbank Mexico is now a reality for all Mexicans who want to manage their finances quickly, easily, 100% digitally, and with th ...

I recommend holding Santander Brasil (NYSE: BSBR ) shares after the release of its 3Q24 results. This article is a continuation of my thesis covering the bank's shares, which is the 3rd largest private bank in Brazil.More than 5 years of experience in equity analysis in LatAm. We provide our clients with in-depth research and insights to help them make informed investment decisions.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans ...

Long-only investment, evaluating companies from an operational, buy-and-hold perspective.Quipus Capital does not focus on market-driven dynamics and future price action. Instead, our articles focus on operational aspects, understanding the long-term earnings power of companies, the competitive dynamics of the industries where they participate, and buying companies that we would like to hold independently of how the price moves in the future. Most QC calls will be holds, and that is by design. Only a very sm ...

Banco Santander, S.A. (NYSE:SAN) Q3 2024 Earnings Conference Call October 29, 2024 5:00 AM ET Company Participants Begona Morenes - Global Head of Investor Relations Jose Garcia Cantera - Senior Executive Vice-President, Chief Financial Officer Hector Grisi Checa - Chief Executive Officer, Executive Director Conference Call Participants Ignacio Ulargui - BNP Paribas Francisco Riquel - Alantra Alvaro Serrano - Morgan Stanley Antonio Reale - Bank of America Marta Sanchez Romero - Citi Carlos Peixoto - CaixaB ...

It's time for me to provide my quarterly update for Banco Santander, S.A. (NYSE: SAN ). Since I last wrote about the bank, we're only up around 3%, with the S&P 500 up around 5%. But I look at the return sinceAnalyst’s Disclosure: I/we have a beneficial long position in the shares of SAN either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relati ...

Santander’s digital banking platform, Openbank, is now officially live in the United States.According to a Monday (Oct. 21) press release, the launch marks a significant expansion of Santander’s U.S. consumer banking operations beyond the Northeast, enabling the bank to serve customers nationwide.Openbank features an onboarding process that can be completed in as little as five minutes via the Openbank app or website, per the release.Built on proprietary technology, Openbank integrates core banking infrastr ...

FORM 6-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of September, 2024 Commission File Number: 001-12518 Banco Santander, S.A. (Exact name of registrant as specified in its charter) Ciudad Grupo Santander 28660 Boadilla del Monte (Madrid) Spain (Address of principal executive of ice) Indicate by check mark whether the registrant files or will file annual reports under cover of Form ...