Sanofi(US:SNY) 智通财经网·2025-12-15 11:05Core 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].