PresentationThomas LarsenHead of Investor Relations Good afternoon and good morning, depending on where you are, and welcome to the Sanofi's first year-end late-stage pipeline review. I'm Thomas Kudsk Larsen from the Investor Relations team and I'm pleased to see so many people on the call today. Before we get started, I want to thank Alizé in the IR team for leading the work on today's call. I also want to remind everyone that our focus is on the clinical and regulatory aspects of the mid- and late-stage ...

Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Company ParticipantsLouisa Hector - Head of Global Pharma Equity ResearchThomas Kudsk Larsen - Head of Investor RelationsSachin Jain - VPSarita Kapila - Co-Head European Pharmaceuticals Equity ResearchSimon Baker - Head of Global Biopharma ResearchNone - Company RepresentativeJames Quigley - Executive DirectorGraham Parry - Managing Director and Head of European Pharmaceuticals Biotechnology Equity ResearchJean-François Toussaint - Global ...

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 ...

新药和疫苗研发 - 2025年，Sanofi获得三种新药和疫苗的批准，包括首个RNAi抗凝血酶药物和首个重组COVID-19疫苗[12] - Dupixent在慢性自发性荨麻疹中获得美国和欧盟的批准，适用于对H1AH治疗无效的成人和儿童[22] - 2025年，Sanofi在美国、欧盟、日本和中国共提交了311项新药申请，涵盖生物制剂、合成分子等多个领域[10] - 2025年，Sanofi的研发团队进行了多项新药的临床试验，涵盖了多种疾病领域[5] - 2025年，Sanofi的研发领导团队进行了重要的人员调整，以增强研发能力[6] - 2025年，duvakitug的II期研究显示出在UC和CD中，治疗组的有效率均超过安慰剂组，且达到了预设的概率阈值[48] - 单价RSV疫苗在二期临床研究中显示出74.9%的有效性，且与已批准的RSV疫苗相当[80] - 新增七种分子进入一期临床阶段，包括针对阿尔茨海默病的TREM2激动剂[89] 临床试验和研究成果 - Sarclisa在多发性骨髓瘤中达成共同主要终点，显示出良好的临床效果[16] - Fluzone HD在50至64岁人群中显示出积极的安全性和免疫原性[16] - Dupixent在皮肤清除和疾病严重程度方面显示出临床显著改善，且在治疗中未发现新的安全性问题[26] - efdoralprin alfa在AATD肺气肿的II期研究中，所有主要和关键次要终点均达成，且在32周时功能性AAT Ctrough显著优于标准治疗（p<0.0001）[56] - riliprubart在CIDP患者的开放标签II期研究中，显示出35%的NfL水平降低，且大多数患者在第76周时保持稳定或改善[69] - Fluzone HD在FLUNITY-HD研究中，针对老年人群体的流感住院率降低了31.9%[75] - balinatunfib在银屑病和类风湿关节炎的II期研究中显示出名义有效性，RA的深度疾病控制指标表现更为鼓舞人心[46] 市场展望和未来计划 - 预计2026年将有超过15项监管决策和30项监管提交[108] - 计划在2026年和2027年进行超过15项三期数据的读取[108] - 2025年将推出三种新药物和疫苗，包括Qfitlia、Wayrilz和Nuvaxovid[106] - 研发数字化计划旨在将研发周期时间减少超过40%[94] 其他重要信息 - 2025年，Sanofi在高声望期刊上发表了201篇科学论文，显示出其在研发领域的活跃度[10] - 目前正在进行的多项III期研究将进一步评估这些新疗法的长期效果和安全性[66] - 组合疫苗的两个成分均显示出良好的有效性，计划在2026年启动二期研究[83]

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... ...

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 ...

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 ...

The major U.S. index futures are currently pointing to a higher open on Monday, with stocks likely to regain ground following the significant weakness seen last Friday.Traders may look to pick up stocks at somewhat reduced levels after last Friday's pullback, which was led by a sell-off among tech stocks.Overall trading activity may be somewhat subdued, however, as traders look ahead to the release of some key U.S. economic data in the coming days.The monthly jobs report for November along with a report on ...

Dren Bio, a private biotech company, said on Monday it has entered into a strategic collaboration with Sanofi to develop therapies for autoimmune diseases in a deal worth up to $1.7 billion. ...

Under the terms of the agreement, Dren Bio will receive an upfront payment of $100 million and is eligible to receive up to $1.7 billion in development, regulatory, and commercial milestone payments. The companies will collaborate on discovery and preclinical development activities leveraging Dren Bio's proprietary platform. Following development candidate selection, Sanofi will assume subsequent responsibility for development, manufacturing, regulatory, and commercialization efforts. Dren Bio has the optio ...