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Press release: Availability of the Q4 2025 Aide memoire
Globenewswire· 2025-12-17 06:30
Core Insights - Sanofi has made its Q4 2025 Aide memoire available on its website to assist in financial modeling of the Group's quarterly results [1] - The document includes reminders on non-comparable items, foreign currency impact, and share count [1] - Sanofi's Q4 and full year 2025 results are scheduled for publication on January 29, 2026 [1] Company Overview - Sanofi is an R&D driven, AI-powered biopharma company focused on improving lives and delivering growth [2] - The company leverages its understanding of the immune system to develop medicines and vaccines for millions globally [2] - Sanofi aims to address urgent healthcare, environmental, and societal challenges through its innovative pipeline [2] Stock Information - Sanofi is listed on EURONEXT under the ticker SAN and on NASDAQ under the ticker SNY [3]
Press Release: Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema
Globenewswire· 2025-12-17 06:00
Core Insights - The European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa for the treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema, addressing a significant unmet medical need in a rare respiratory condition [1][2][3] Group 1: Efdoralprin Alfa Overview - Efdoralprin alfa (SAR447537, formerly INBRX-101) is an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein aimed at treating AATD emphysema [1][4] - The drug has shown superiority over standard plasma-derived therapy in adults with AATD in the global phase 2 ElevAATe study, meeting all primary and key secondary endpoints [2][4] - Efdoralprin alfa has also received fast track and orphan drug designations from the US FDA, indicating its potential significance in treating AATD [3][4] Group 2: Alpha-1 Antitrypsin Deficiency (AATD) - AATD is a rare inherited disorder characterized by low or absent levels of AAT, leading to progressive lung and liver tissue damage [5] - Approximately 235,000 individuals globally are affected by AATD, with nearly 100,000 in the US, and about 90% of these cases remain undiagnosed [5] Group 3: Sanofi's Commitment - Sanofi is dedicated to developing treatments for rare diseases, as evidenced by the recent orphan designation for efdoralprin alfa [7] - The company emphasizes its commitment to improving lives through innovative research and development in the biopharma sector [6]
一日豪掷200亿!除了Dupixent,赛诺菲还剩什么?
Xin Lang Cai Jing· 2025-12-17 04:30
来源:市场资讯 (来源:求实药社) 2025年12月15日,赛诺菲在一天之内按下了两次巨额交易的确认键。 这家法国制药巨头先是宣布与韩国ADEL达成10.4亿美元合作,引进一款处于临床早期的阿尔茨海默病 (AD)抗体;随即又以最高17亿美元的金额深化与美国Dren Bio的合作,加码自身免疫平台。 单日27.4亿美元(约合人民币近200亿)的投入,在资本寒冬尚未完全消退的当下显得尤为刺眼。然 而,这并非一场轻松的"庆功宴",更像是一次不得不为的高风险资产置换。 在刚刚剥离了现金流稳定的消费者健康业务(Opella)之后,赛诺菲正急于向市场证明,其激进的"纯 创新药"战略能够跑通。这27亿美元的押注,折射出的是一家MNC在专利悬崖与研发困境夹击下的破局 渴望与深层焦虑。 一、 神经科学的"补课":Tolebrutinib阴影下的对冲 在AD这个被称为"研发黑洞"的领域,赛诺菲不仅是一个后来者,更是一个面临巨大压力的追赶者。 目前的AD市场,卫材与礼来的Aβ(β-淀粉样蛋白)抗体已经抢占了第一波商业化高地。赛诺菲避开了 拥挤的Aβ赛道,转而选择靶向乙酰化Tau蛋白(acK280)的差异化路线。从科学机制上看,AD ...
SNY Stock Down on Double Trouble With Multiple Sclerosis Drug
ZACKS· 2025-12-16 16:46
Key Takeaways SNY stock fell nearly 2% after two setbacks tied to Sanofi's investigational MS drug tolebrutinib.The FDA pushed its decision on tolebrutinib for nrSPMS to the first quarter of 2026 after new submissions.SNY said tolebrutinib failed the primary endpoint in a phase III PPMS study, ending development in that use.Shares of Sanofi (SNY) fell nearly 2% on Monday after the company reported two setbacks in connection with its investigational multiple sclerosis (MS) drug, tolebrutinib.FDA Delays Decis ...
Sanofi (NasdaqGS:SNY) Earnings Call Presentation
2025-12-16 16:15
R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]
界面新闻揭晓2025年度跨国公司中国区CEO榜单:巴斯夫、菲婷丝、赛诺菲等10位大中华区/中国区CEO上榜
Xin Lang Cai Jing· 2025-12-16 08:08
智通财经记者 | 史国伟 智通财经连续第9年推出超级CEO系列榜单。该系列榜单关注各行业中带领企业稳步向强,不断取得财 务成长,为长短期股东带来回报,并兼顾个人声誉的优秀管理者。除「年度超级CEO」主榜单外,今年 的系列子榜单包括「年度金融行业CEO」、「年度新能源行业CEO」、「年度汽车行业CEO」、「年度 医疗健康行业CEO」、「年度科技行业CEO」、「年度女性CEO」以及「年度跨国公司中国区CEO」。 商务部发布的《中国外资统计公报2025》显示,2024年中国实际利用外资1162.4亿美元,同比下降 28.8%,这已是该数字于2022年触顶之后连续两年下降。但2024年中国实际利用外资规模仍居全球第4 位,且连续第33年居发展中国家首位,占当年全球FDI(外国直接投资)总量的7.7%。 中国实际使用外资规模下降,是全球宏观环境、各国政策调整、国内经济转型以及国际竞争格局变化共 同作用的结果。首先是全球投资环境低迷,全球FDI总量因全球经济复苏乏力、地缘政治等因素而持续 萎缩,形成"蛋糕变小"的局面。同时,全球贸易保护主义盛行,投资审查与投资限制增多,美国、欧盟 等经济体普遍强化外商投资审查,特别针对高 ...
South Korea's ADEL signs up to $1.04 billion Alzheimer's drug development deal with Sanofi
Reuters· 2025-12-15 23:57
South Korea-based ADEL said late on Monday that it has entered a $1.04 billion partnership with French drugmaker Sanofi to develop and sell the biotech company's experimental Alzheimer's disease treat... ...
Sanofi: Today's Tolebrutinib Setback Shouldn't Worry Shareholders - This Is Why
Seeking Alpha· 2025-12-15 19:51
If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...
Sanofi Expands Dren Bio Partnership With Potential $1.7 Billion Autoimmune Disease Collaboration
Benzinga· 2025-12-15 18:10
Dren Bio, a privately held, clinical-stage biotechnology company, has a new collaboration with Sanofi SA (NASDAQ:SNY) . The new agreement is built on the existing relationship between the two companies, following Sanofi’s acquisition earlier this year of Dren Bio’s DR-0201 program for deep B-cell depletion. • Sanofi shares are experiencing downward pressure. Why are SNY shares declining?The collaboration covers the discovery and development of a next-generation B-cell depleting therapy for the treatment of ...
Dren Bio to collaborate with Sanofi to develop autoimmune disease therapies for up to $1.7 billion
Reuters· 2025-12-15 13:21
Core Insights - Dren Bio has entered into a strategic collaboration with Sanofi to develop therapies for autoimmune diseases, with a deal valued at up to $1.7 billion [1] Company Summary - Dren Bio is a private biotech company focused on developing therapies for autoimmune diseases [1] - Sanofi is a global healthcare leader collaborating with Dren Bio for the development of these therapies [1] Financial Summary - The collaboration deal is worth up to $1.7 billion, indicating significant financial commitment from both companies [1]