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 ...

Market Movements - US stock index futures are all up, with Dow futures rising by 0.47%, S&P 500 futures up by 0.50%, and Nasdaq futures also increasing by 0.50% [1] - European indices are also showing positive movements, with Germany's DAX up by 0.44%, UK's FTSE 100 up by 0.94%, France's CAC40 up by 1.13%, and the Euro Stoxx 50 up by 0.74% [1] Commodity Prices - WTI crude oil has decreased by 0.42%, trading at $57.00 per barrel, while Brent crude oil has fallen by 0.41%, priced at $60.87 per barrel [2] Economic News - The market is focused on the potential candidates to succeed Jerome Powell as the next Federal Reserve Chair, with President Trump suggesting Kevin Hassett or Kevin Warsh [3] - Key economic data, including the November employment report and CPI data, are set to be released this week, following a recent 25 basis point rate cut by the Fed [3][4] - The bond market is engaged in intense discussions regarding the Fed's future rate cuts, with expectations of two rate cuts next year despite persistent inflation [4] Company News - iRobot has filed for Chapter 11 bankruptcy protection, indicating that existing common stockholders will not receive any equity in the restructured company [6][7] - STMicroelectronics is expected to deliver over 5 billion Starlink chips in the next two years, reflecting the growing demand in the commercial space sector [7] - Sanofi's multiple sclerosis drug tolebrutinib faces delays in FDA approval and has failed in a late-stage trial, potentially threatening its projected $1.7 billion annual sales peak [8] - Argenx has terminated its trial for a thyroid eye disease drug based on recommendations from an independent data monitoring committee, impacting its treatment goals [8] - Rocket Lab has successfully executed its first dedicated launch mission for JAXA, marking a significant milestone for the company in the commercial space sector [9]

盘前市场动向 1. 12月15日(周一)美股盘前，美股三大股指期货齐涨。截至发稿，道指期货涨0.47%，标普500指数期货涨0.50%，纳指期货涨 0.50%。 | = US 30 | 48,683.70 | 48,691.50 | 48,414.10 | +225.60 | +0.47% | | --- | --- | --- | --- | --- | --- | | = US 500 | 6,861.60 | 6,862.70 | 6,816.80 | +34.20 | +0.50% | | = US Tech 100 | 25,323.00 | 25,332.50 | 25,123.40 | +126.30 | +0.50% | 2. 截至发稿，德国DAX指数涨0.44%，英国富时100指数涨0.94%，法国CAC40指数涨1.13%，欧洲斯托克50指数涨0.74%。 | 德国DAX30 | 24,318.56 | 24,338.06 | 24,237.56 | +107.19 | +0.44% | | --- | --- | --- | --- | --- | --- | | 瑞 英国富时100 | ...

Cleveland Fed President Beth Hammack said on Friday that she would prefer interest rates to be somewhat more restrictive to continue putting pressure on inflation, which remains too high. “Right now, we’ve got policy that’s right around neutral,” Hammack said. Also, Kansas City Fed President Jeffrey Schmid said he dissented against the latest FOMC’s decision to cut interest rates because inflation remains “too high” and policy should stay modestly restrictive to contain it. At the same time, Chicago Fed Pre ...

Core Viewpoint - Sanofi's experimental multiple sclerosis drug tolebrutinib faces dual setbacks with regulatory delays in the U.S. and a failed late-stage clinical trial, impacting its potential annual sales peak of $1.7 billion [1][2]. Group 1: Regulatory Delays - The FDA's approval decision for tolebrutinib may be delayed, with further guidance expected by the end of Q1 [1]. - The review process was previously postponed by three months in September [2]. Group 2: Clinical Trial Results - In a late-stage trial for primary progressive multiple sclerosis, tolebrutinib failed to delay the progression of disability in patients [2]. - Sanofi will not seek regulatory approval for this indication, which accounts for approximately 10% of total patients [3]. Group 3: Market Impact - Sanofi's stock price fell by 6.4% in early trading, marking the largest drop in over three months, and has declined 15% year-to-date, underperforming its peers [1][3]. - Analysts express cautious optimism about the drug's approval potential despite current setbacks, citing unmet medical needs and ongoing data submissions for expanded access [2]. Group 4: Financial Implications - The company is conducting an asset impairment test related to tolebrutinib and will provide updates in January, with no impact expected on its main profit indicators or 2025 earnings guidance [2].

Core Viewpoint - Shares of French pharmaceutical group Sanofi experienced a significant decline following the announcement of another delay in the US regulatory decision for its experimental multiple sclerosis drug tolebrutinib [1] Group 1 - Sanofi's stock price fell sharply on Monday due to the regulatory delay [1] - The delay pertains to the US regulatory decision regarding the multiple sclerosis drug tolebrutinib [1]

赛诺菲(SNY.US)盘前跌超4%，报46.65美元。消息面上，赛诺菲预计，tolebrutinib用于非复发性继发进 展型多发性硬化症(nrSPMS)的美国监管审查过程将超出此前沟通的2025年12月28日的目标行动日期， 并预计将在2026年第一季度末之前收到来自FDA的进一步指导。(格隆汇) ...

Core Viewpoint - The U.S. Food and Drug Administration's decision on Sanofi's investigative drug for multiple sclerosis is expected to be delayed until the first quarter of 2026, moving from the previously communicated date of December 28 [1] Company Summary - Sanofi is a French pharmaceutical group that is currently awaiting a decision from the U.S. FDA regarding its drug for treating multiple sclerosis [1]

A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn’t hit its main goal. https://t.co/xkDbc3jwYF ...

A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn't hit its main goal. ...