Core Viewpoint - Sanofi's tolebrutinib, an investigational treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS), has received a complete response letter (CRL) from the FDA, indicating a significant setback in its regulatory submission process [1][3]. Regulatory Update - The FDA's review of tolebrutinib is expected to extend beyond the previously set target action date of December 28, 2025, with further guidance anticipated by the end of Q1 2026 [2]. - Sanofi has submitted an expanded access protocol for tolebrutinib in response to an FDA request [2]. Company Response - Sanofi expressed disappointment regarding the FDA's decision, emphasizing the unmet medical need for addressing disability progression in MS and the previous breakthrough therapy designation awarded to tolebrutinib [3]. - The company remains committed to collaborating with the FDA to find a path forward for tolebrutinib [3]. Product Information - Tolebrutinib is designed as an oral, brain-penetrant Bruton's tyrosine kinase inhibitor targeting neuroinflammation, which is a key factor in disability progression in MS [6]. - The drug was provisionally approved in the UAE in July 2025 for treating nrSPMS and is under review in the EU and other regions [4]. Financial Considerations - Sanofi is conducting an impairment test on the intangible asset value of tolebrutinib, with results expected to be reported alongside Q4 and FY 2025 results in January 2026 [5]. - The outcome of this test will not affect the company's net income or earnings per share, and there is no change to the financial guidance for 2025 [5]. Commitment to Innovation - Tolebrutinib reflects Sanofi's dedication to developing innovative treatments for neurological diseases, aiming to transform the treatment landscape for conditions like MS and other neurodegenerative disorders [7].

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITPApproval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptomsITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life Paris, December 23, 2025 – The European Commission ...

Core Viewpoint - Sanofi and Regeneron's Dupixent has received approval in Japan for treating bronchial asthma in children aged 6 to 11 years, expanding its previous approval for patients aged 12 and older [1][4]. Group 1: Approval and Clinical Data - The approval is based on data from the VOYAGE global phase 3 study, which showed that Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo [2][8]. - Additional support for the approval came from the EXCURSION study, which included a sub-study of Japanese pediatric patients, demonstrating improved lung function and a low rate of severe exacerbations over one year [2][8]. Group 2: Asthma in Children - Asthma is a prevalent chronic disease in children, often leading to serious symptoms and impaired lung function, which can have long-lasting effects if not treated early [3]. - Uncontrolled asthma can disrupt daily activities such as sleeping, attending school, and playing sports [3]. Group 3: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation [6][8]. - The drug is available in Japan as a 200 mg or 300 mg pre-filled syringe or pen, administered subcutaneously every two or four weeks based on weight [5]. Group 4: Broader Indications and Global Reach - In addition to asthma, Dupixent is approved for various conditions in Japan, including atopic dermatitis and chronic rhinosinusitis with nasal polyposis [4]. - Dupixent has received regulatory approvals in over 60 countries and is currently being used to treat more than 1.3 million patients globally [7].

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofia French société anonyme with a registered share capital of €2,438,854,192Registered office : 46, avenue de la Grande Armée - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under nu ...

Core Insights - The Trump administration has signed drug-pricing agreements with several large-cap drugmakers to lower drug prices in the U.S. [1] - The agreements require drugmakers to reduce prescription drug prices to match those in comparable developed countries, supporting the Most Favored Nation (MFN) pricing proposal [2] - Drugmakers will receive a three-year exemption from import tariffs on pharmaceutical ingredients in exchange for expanding domestic manufacturing operations [3] - Some companies will donate active pharmaceutical ingredients (APIs) to a government stockpile to ensure supply chain resilience during emergencies [4] - The Trump administration has now reached deals with 14 out of 17 targeted drug manufacturers, with three companies still in discussions [5] Industry Impact - The agreements address major concerns regarding drug pricing and tariffs, improving investor outlook for the pharmaceutical sector [6] - The deals are seen as a turning point that could alleviate regulatory and pricing pressures on the industry [7] - The latest agreements involve nine major drugmakers, joining others like Pfizer and AstraZeneca who signed similar deals earlier [8]

Ah, the markets. A bastion of rationality, predictability, and calm, right? Not when Donald J. Trump is in the driver’s seat, or even just tweeting from the back. The year 2025 has proven to be yet another masterclass in market volatility, where a single pronouncement can send trillions soaring or plummeting, often with the same dizzying speed as a Truth Social post going viral. Investors, bless their hearts, have spent the better part of the year clutching their pearls and portfolios, trying to decipher wh ...

Ah, the stock market. A bastion of rational thought, predictable trends, and calm, measured reactions. Or, if you’ve been paying attention to the last few years, a chaotic pinball machine where the flippers are controlled by presidential tweets and the ball bounces wildly between “historic deals” and “massive tariffs.” Welcome back to the exhilarating, if slightly whiplash-inducing, world of the Trump economy, where policy pronouncements often serve as the opening bell for a fresh round of market gymnastics ...

Group 1: Drug Price Cuts and Pharmaceutical Stocks - President Trump announced significant drug price cuts in collaboration with nine major pharmaceutical companies, aiming to align U.S. drug costs with those in other developed nations [2] - Despite the announcement of price cuts, shares of involved drugmakers like GSK, Merck, Amgen, Novartis, Sanofi, and Roche rose by approximately 1% to 3%, as the deals removed the immediate threat of punitive tariffs for three years [3] - Analysts noted that the deals serve more as a public relations strategy rather than a substantial change in company economics, with Medicaid already benefiting from significant discounts [4] Group 2: Market Reactions to Health Insurers - Major health insurers such as Cigna, CVS Health, Elevance Health, and UnitedHealth Group experienced an initial dip of about 1% following Trump's comments but quickly recovered, indicating a market accustomed to Trump's policy announcements [5] Group 3: Merger of Trump Media & Technology Group and TAE Technologies - Trump Media & Technology Group announced a merger with TAE Technologies, valuing the combined entity at $6 billion, which led to a 42% surge in DJT shares, closing at $14.86 [7] - The merger has drawn mixed reactions, with some analysts viewing it as a significant move towards creating a public nuclear fusion company, while others criticized it as a questionable venture [9] Group 4: Tariff Threats and Market Volatility - Throughout 2025, Trump's threats and impositions of tariffs, particularly against China, have caused significant market volatility, including a $5 trillion market wipeout following an April tariff announcement [11] - The S&P 500 and Nasdaq Composite experienced substantial declines during tariff threats, but the market has shown resilience, often recovering to new highs [12] Group 5: Overall Market Environment - As 2025 concludes, the financial markets continue to be influenced by Trump's unpredictable policies, creating a landscape where traditional analysis is often overshadowed by political developments [13]

本文源自：金融界AI电报 赛诺菲(SNY.O)：协议不会影响三年期内的主导增长战略或财务展望。 ...

Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation Agreement delivers on President Trump’s four requests, establishing a framework for lower prices for patients in the US and a tariff-free accord for SanofiShowcases commitment to US manufacturing, innovation, and economic growth Paris, December 19, 2025. Sanofi today announced an agreement with President Donald J. Trump's Administration to help ensure American patients have access to more affordable medici ...