Summary of Key Points Core Viewpoint - The document provides information regarding the total number of voting rights and shares for Sanofi, a French société anonyme, as required by French commercial regulations. Group 1: Voting Rights and Shares - As of August 31, 2025, Sanofi has a total of 1,227,469,992 issued shares [1] - The number of real voting rights, excluding treasury shares, is 1,352,853,696 [1] - The theoretical number of voting rights, including treasury shares, is 1,361,794,887 [1] Group 2: Company Information - Sanofi has a registered share capital of €2,454,937,946 [1] - The company is registered at the Paris Commercial and Companies Registry under number 395 030 844 [1] - The registered office is located at 46, avenue de la Grande Armée, 75017 Paris, France [1]

Core Viewpoint - The U.S. government, led by President Trump, is pressuring major pharmaceutical companies to lower drug prices in the U.S. by adhering to the "most-favored-nation" (MFN) pricing policy, which aims to align U.S. drug prices with the lowest prices in other developed countries [1][2][3] Group 1: Government Actions - President Trump has set a deadline of September 29 for pharmaceutical companies to comply with the MFN policy [2] - Multiple federal departments are being mobilized to support this initiative, indicating a coordinated effort to enforce the price reductions [2][3] Group 2: Pharmaceutical Companies Involved - Major pharmaceutical companies receiving Trump's letter include Eli Lilly (LLY.US), Pfizer (PFE.US), Merck (MRK.US), Gilead (GILD.US), Bristol-Myers Squibb (BMY.US), Johnson & Johnson (JNJ.US), Regeneron (REGN.US), Amgen (AMGN.US), AbbVie (ABBV.US), and several European firms such as Merck KGaA, Sanofi (SNY.US), GlaxoSmithKline (GSK.US), AstraZeneca (AZN.US), Novo Nordisk (NVO.US), Roche (RHHBY.US), and Novartis (NVS.US) [1] Group 3: Implications of High Drug Prices - The long-term high drug prices in the U.S. create significant pressure on both public welfare and government finances, making the MFN policy a direct and quantifiable approach to reduce costs [3] - The lack of price regulation in the U.S. compared to other countries contributes to higher drug prices, as U.S. pharmaceutical companies can raise prices without negotiation [3]

Core Insights - Sanofi's investigational gene therapy SAR402663 received fast track designation from the FDA for treating neovascular (wet) age-related macular degeneration (AMD) [1][6] Group 1: Fast Track Designation Benefits - Fast track designation aims to expedite the development and review of drugs addressing serious conditions and unmet medical needs, allowing for earlier patient access [2] - The designation enables rolling review, allowing Sanofi to submit completed sections of the regulatory filing for SAR402663 as they become available, potentially speeding up the evaluation process [2][6] Group 2: Product Details - SAR402663 is a one-time intravitreal gene therapy targeting vascular endothelial growth factor (VEGF), which is responsible for abnormal blood vessel growth in the eye [5][6] - The therapy aims to reduce treatment burden by eliminating the need for frequent intravitreal injections [5][6] Group 3: Clinical Development - Sanofi is currently conducting a phase I/II study for SAR402663 in patients with neovascular/wet AMD, a severe condition affecting over a million people in the United States [7] Group 4: Competitive Landscape - Key competitors include AbbVie's ABBV-RGX-314, which is also a one-shot gene therapy targeting VEGF and is in pivotal studies for wet AMD, with data expected next year [8] - Another competitor is 4D Molecular Therapeutics' 4D-150, which is also targeting VEGF and is undergoing late-stage studies for wet AMD, with data anticipated in the second half of 2027 [9]

Core Insights - The FDA has granted fast track designation to Sanofi's SAR402663, a one-time intravitreal gene therapy for neovascular age-related macular degeneration (AMD) [1][7] - This designation aims to expedite the development and review of treatments for serious conditions, addressing unmet medical needs [1] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [5] - The company is exploring therapies for various neurological diseases, including AMD, and aims to leverage scientific innovation in ophthalmology for growth [4] Product Details - SAR402663 delivers genetic material that encodes soluble FLT01, designed to inhibit vascular endothelial growth factor (VEGF), addressing the underlying pathology of neovascular AMD [2] - The therapy aims to reduce treatment burden by eliminating the need for frequent intravitreal injections, which is a significant advantage for patients [2][7] Market Context - Neovascular AMD affects over one million people in the US and approximately six million people worldwide, significantly impacting quality of life [3] - The condition is characterized by abnormal blood vessel growth beneath the retina, leading to vision loss and potential blindness [3]

Core Insights - The FDA has granted fast track designation to Sanofi's SAR402663, a one-time intravitreal gene therapy for neovascular age-related macular degeneration (AMD) [1][7] - The fast track designation aims to expedite the development and review of treatments for serious conditions, addressing unmet medical needs [1] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [5] - The company is exploring therapies for various neurological diseases, including AMD, and aims to leverage scientific innovation in ophthalmology for growth [4] Product Details - SAR402663 delivers genetic material designed to inhibit vascular endothelial growth factor (VEGF), addressing the underlying pathology of neovascular AMD by reducing abnormal blood vessel growth and minimizing retina damage [2] - The therapy aims to significantly reduce the treatment burden by eliminating the need for frequent intravitreal injections [2] Market Context - Neovascular AMD affects over one million people in the US and approximately six million people worldwide, leading to significant vision loss and impacting quality of life [3][7] - AMD is a progressive degeneration of the retina that affects around 200 million people globally, highlighting the substantial market potential for effective treatments [3]

Group 1 - The core message emphasizes the strategic importance of the Höchst Industrial Park as a hub for Chinese companies to integrate into the European industrial ecosystem, showcasing Germany's leading position in the chemical and pharmaceutical industries [1][2] - The Höchst Industrial Park has a history of 150 years and is home to over 90 top global chemical and pharmaceutical companies, making it one of the largest research and production bases in Europe [2] - Sinopec, Shanghai Electric, and Huawei expressed strong intentions to enhance cooperation in emerging fields such as research and development centers, new energy, biomedicine, and digital technology [2] Group 2 - The park features significant infrastructure, including an independent power plant, hydrogen station, and port facilities, providing comprehensive support services such as energy and raw material supply, waste treatment, logistics, and vocational training [1] - Sanofi is set to invest €1.3 billion to expand the world's largest insulin production base in the park by 2024, while startups are establishing new lithium battery electrolyte factories and plastic degradation laboratories [2]

Accessibility StatementSkip Navigation MORRISTOWN, N.J., Sept. 10, 2025 /PRNewswire/ -- Sanofi is partnering with celebrity moms who chose to immunize their babies with BEYFORTUSÂ (nirsevimab-alip) to help educate families about the importance of RSV infant protection. BEYFORTUS is the first long-acting monoclonal antibody approved to prevent a serious RSV lung infection in newborns and infants entering their first RSV season, as well as in children up to 24 months of age who remain at risk for severe RSV t ...

Core Viewpoint - Tzield (teplizumab) has been approved in China as the first disease-modifying therapy for stage 2 type 1 diabetes (T1D), aimed at delaying the onset of stage 3 T1D in both adult and pediatric patients aged eight years and older [1][3] Group 1: Approval and Study Results - The approval by the Chinese National Medical Products Administration (NMPA) was based on positive results from the TN-10 phase 2 study, which showed that Tzield delayed the median onset of stage 3 T1D by 48.4 months compared to 24.4 months in the placebo group [2][6] - Tzield is already approved in several countries including the US, UK, Canada, Israel, Saudi Arabia, UAE, and Kuwait for the same indication, with ongoing regulatory reviews in the EU and other regions [4][5] Group 2: Significance and Impact - The approval signifies a new era of care for stage 2 T1D patients in China, focusing on Tzield's unique ability to preserve beta-cell function, potentially reducing the treatment burden for patients [3][5] - Recent expert consensus guidelines in China emphasize the importance of protecting beta-cell function in managing autoimmune T1D, validating Tzield's therapeutic value in addressing significant clinical needs [3][6] Group 3: About Tzield and T1D - Tzield is a CD3-directed monoclonal antibody and the first disease-modifying therapy for autoimmune T1D, initially approved in the US in November 2022 [5][6] - T1D is characterized by the autoimmune destruction of insulin-producing beta cells, progressing through four stages, with stage 2 marked by abnormal blood sugar levels due to beta-cell loss [6][7]

Group 1 - The company anticipates a placeholder of around 15% for U.S. tariffs by 2025, indicating a manageable impact on operations [1] - There is no specific guidance provided for the year 2026 regarding tariffs, suggesting ongoing assessment of the situation [1] - The company has conducted scenario analysis to prepare for potential tariff impacts, indicating a proactive approach to risk management [1]

Company Overview - Granada Gold Mine Inc. has appointed Heidi Gutte as the new Chief Financial Officer, effective immediately, replacing Remantra Sheopaul [1] - Heidi Gutte brings nearly 15 years of experience in corporate finance, IFRS financial reporting, audit preparation, tax optimization, and corporate compliance within the mineral exploration and junior mining sector [2] - The company expresses gratitude to Mr. Sheopaul for his contributions and wishes him well in future endeavors [3] Mining Operations - Granada Gold Mine Inc. is actively developing and exploring its 100% owned Granada Gold Property located near Rouyn-Noranda, Quebec, which is adjacent to the Cadillac Break [5] - The company owns 14.73 square kilometers of land, consisting of mining leases and claims, and is currently conducting a large drill program with 20,000 meters completed out of a planned 120,000 meters [5] - Drilling operations are currently paused to allow the technical team to evaluate existing data and await improved market conditions [5] Historical Production - The Granada Shear Zone and the South Shear Zone contain up to twenty-two mineralized structures trending east-west over five and a half kilometers, with historical underground grades ranging from 8 to 10 grams per tonne gold [6] - The former Granada Gold underground mine produced over 50,000 ounces of gold at a grade of 10 grams per tonne in the 1930s before a fire destroyed surface buildings [7] - In the 1990s, Granada Resources extracted a bulk sample of 87,311 tonnes grading 5.17 grams per tonne gold from Pit 1 and 22,095 tonnes grading 3.46 grams per tonne gold from Pit 2 [7]