Sanofi (SNY) announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).The candidate is being developed in separate mid-stage studies for treating wAIHA and IgG4-RD, two rare diseases.Currently, there are no approved therapies for treating wAIHA and IgG4-RD. Both diseases have a significant unmet medical need.The FDA grants orphan drug designation to support ...

The U.S. Food and Drug Administration (FDA) on Thursday granted orphan drug designation to Sanofi SA‘s SNY rilzabrutinib.The treatment is an investigational, novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).The FDA grants orphan drug designation to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the US.Rilzabrutinib ...

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related diseaseRilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia  Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK) in ...

Sanofi (SNY) announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults. The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.The FDA filing is supported by data from three late-stage studies — one ( ...

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 set 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 prevalent bacterial infection with 129 million cases reported globally in 2020 among adults aged 15-49, particularly affecting 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 [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].

Sanofi (SNY) announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults. The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.The FDA filing is supported by data from three late-stage studies — one ( ...

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activityTolebrutinib has the potential to be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in MSTolebrutinib was granted breakthrough t ...

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 ...

据悉，这74.5亿欧元债务发行包括54.5亿欧元的欧元和美元杠杆贷款，以及20亿欧元的债券。而根据此 前的报道，还有12亿欧元的循环信贷安排也是此次融资支持的一部分，这将使融资总额达到86.5亿欧 元。 当去年CD&R宣布以约150亿欧元收购Opella的股份时，银行渴望重新为杠杆收购提供资金，因为此类交 易是金融领域最赚钱的交易之一，而Opella收购案是去年欧洲为数不多规模最大的交易之一。不过，这 笔交易如今来到了一个"有趣的"时刻，美国总统特朗普的贸易战引发了大西洋两岸的动荡和经济不确定 性。近几天来，不少欧洲和美国企业都搁置了进军贷款市场风险最高领域的计划。 高盛(GS.US)、花旗(C.US)等银行启动74.5亿欧元债 务发行 为CD&R收购赛诺菲(SNY.US)子公司融资 知情人士透露，此次融资的全球协调人包括高盛、花旗、法国巴黎银行、摩根士丹利、巴克莱、汇丰控 股和法国兴业银行。另外，据此前报道，欧元部分的目标定价比Euribor高350个基点，美元部分的目标 定价比SOFR高325个基点。 智通财经APP获悉，包括高盛(GS.US)和花旗(C.US)在内的银行已经启动了74.5亿欧元(约合81 ...

Sanofi (SNY) announced that it signed an agreement with California-based privately held biopharmaceutical company Dren Bio to acquire the latter’s investigational bispecific antibody DR-0201.DR-0201 is a CD20-directed bispecific myeloid cell engager designed to induce deep B-cell depletion. Dren Bio is currently evaluating the drug in two ongoing early-stage studies — B-cell non-Hodgkin lymphoma and autoimmune diseases.Sanofi believes that DR-0201 has the potential to reset the immune system, which can lead ...