Florent Cespedes

Luisa Hector

Peter Verdult

David Risinger

Graham Parry

Jo Walton

Richard Vosser

Seamus Fernandez

Simon Baker

Benjamin Jackson

Eric Le Berrigaud

Sarita Kapila

Shirley Chen

Ben Jackson

Colleen Garvey

Emily Field

Emmanuel Papadakis

Gary Steventon

James Quigley

Matthew Weston

Peter Welford

Ricardo Benevides Freitas

Sachin Jain

Steve Scala

Timothy Anderson

Xiaobin Gao

- **Sanofi** will expand its Insulins Valyou Savings Program to offer a **30-day supply of any Sanofi insulin for a fixed price of $35 per month** to all U.S. patients with a valid prescription, effective **January 1, 2026**.  **[1121404_b47b7d89fdef4cd1b49341a440e2f587]** 
- This expansion includes individuals with **commercial insurance and Medicare**, broadening the program beyond its initial scope for uninsured individuals.  **[1121404_b47b7d89fdef4cd1b49341a440e2f587]** 
- The company generates approximately **45% of its total revenue from the United States** and has a market capitalization of about **$109.84 billion**, underscoring the significance of this U.S. market initiative.  **[1121404_b47b7d89fdef4cd1b49341a440e2f587]**

Sanofi Expands $35 Monthly Insulin Program To All US Patients

- Sanofi's **SAR446268** was granted **US Food and Drug Administration (FDA) fast track designation** on **September 23, 2025**, for the treatment of non-congenital myotonic dystrophy type 1 (DM1).  **[1121404_0001193125-25-219016_d29732dex991.htm:0]** 
- This designation aims to **expedite the development and review** of the one-time AAV gene therapy, which addresses a **rare genetic disorder with no currently approved medicines**.  **[1121404_0001193125-25-219016_d29732dex991.htm:0]** 
- The therapy is currently in a **first-in-human, phase 1-2 study**, with the **first patient planned for enrollment in late 2025**.  **[1121404_0001193125-25-219016_d29732dex991.htm:0]**

Sanofi's SAR446268 Earns US Fast Track Designation

- Sanofi's CEO, Paul Hudson, stated that the company's **underlying performance is strong** and they are **growing fast**, aiming for **high single-digit growth** and being one of the fastest-growing big pharmas.  **[1121404_2153478_0]** **[1121404_2153478_3]**  He expects to provide more precision on the year's finish and 2026 approach at Q3.  **[1121404_2153478_0]** 
- The company is advancing its pipeline, with **positive feedback on Brevecumab and Amelior**.  **[1121404_2153478_0]**  Tolibrutinib's PDUFA was extended for further data review  **[1121404_2153478_0]** , and **Rilzabrutinib has launched in ITP** with other indications planned.  **[1121404_2153478_5]** **[1121404_2153478_10]** 
- Sanofi is targeting **$10 billion in new product sales by the end of the decade**.  **[1121404_2153478_12]**  Additionally, the non-mRNA flu-COVID vaccine from the Novavax deal is anticipated for approval in **2027 or 2028**.  **[1121404_2153478_12]** 
- Regarding R&D, the CEO noted that **spend will increase slightly** with a different blend, including pruning less promising life cycle management (LCM) strategies.  **[1121404_2153478_3]**  He acknowledged the R&D journey has been bumpy but is focused on accumulating wins.  **[1121404_2153478_10]**

Sanofi CEO Discusses Strong Performance, Pipeline Progress, and Future Growth Targets at Bank of America Conference

- The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a **positive opinion recommending the approval of Dupixent** (dupilumab) in the EU for the treatment of **chronic spontaneous urticaria (CSU)** in adults and adolescents.  **[1121404_0001193125-25-211134_d36300dex991.htm:1]** 
- This recommendation covers patients aged **12 years and above** with moderate to severe disease, who have had an inadequate response to histamine-1 antihistamines and are naive to anti-immunoglobulin E (IgE) therapy.  **[1121404_0001193125-25-211134_d36300dex991.htm:1]** 
- A **final decision on approval is anticipated in the coming months**.  **[1121404_0001193125-25-211134_d36300dex991.htm:1]** 
- If approved, Dupixent would be the **first targeted medicine in over a decade** indicated for CSU in the EU.  **[1121404_0001193125-25-211134_d36300dex991.htm:1]** 
- Dupixent is already approved for CSU in certain adults and adolescents in countries including **Japan and the US**.  **[1121404_0001193125-25-211134_d36300dex991.htm:1]**

Sanofi and Regeneron's Dupixent receives positive EU regulatory opinion for chronic spontaneous urticaria

- **Sanofi's Tzield (teplizumab)** received approval from the Chinese National Medical Products Administration (NMPA) on **September 10, 2025**, becoming the **first disease-modifying therapy** in China for adult and pediatric patients aged eight years and older with **stage 2 type 1 diabetes (T1D)**.  **[1121404_0001193125-25-205799_d26807dex991.htm:0]** 
- The approval was based on positive results from the **TN-10 phase 2 study**, which demonstrated Tzield's ability to delay the median onset of stage 3 T1D by **48.4 months** compared to **24.4 months** in the placebo group.  **[1121404_0001193125-25-205799_d26807dex991.htm:0]** 
- This approval signifies a new approach to care for stage 2 T1D patients in China, focusing on preventing disease progression by preserving beta-cell function.  **[1121404_0001193125-25-205799_d26807dex991.htm:0]** 
- Tzield is also approved for the same indication in the **US, UK, Canada, Israel, Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait**, with regulatory reviews ongoing in the EU and other jurisdictions.  **[1121404_0001193125-25-205799_d26807dex991.htm:0]**

Sanofi's Tzield Approved in China

- **Sanofi's WAYRILZ (rilzabrutinib)** received **US approval** in **August 2025** as the **first FDA-approved BTK inhibitor** for treating immune thrombocytopenia.  **[1121404_d7561e5d31f44eafa6c744a374f12e7e_0]** **[1121404_d7561e5d31f44eafa6c744a374f12e7e_1]** **[1121404_d7561e5d31f44eafa6c744a374f12e7e_3]** 
- The immune thrombocytopenic purpura (ITP) market was valued at **USD 3.8 billion** in 2024 across leading markets (US, EU4, UK, and Japan) and is projected to grow at a **CAGR of 1.9%** during the forecast period (2025–2034).  **[1121404_d7561e5d31f44eafa6c744a374f12e7e_0]** **[1121404_d7561e5d31f44eafa6c744a374f12e7e_5]** 
- WAYRILZ is priced at **$17,500 per month** and is anticipated to be a **key growth driver**, benefiting from **14 years of US market exclusivity** due to its orphan drug designations.  **[1121404_d7561e5d31f44eafa6c744a374f12e7e_2]**

Sanofi's WAYRILZ Receives US Approval for Immune Thrombocytopenia

- Sanofi's investigational one-time intravitreal gene therapy, **SAR402663**, has received **Fast Track designation** from the US Food and Drug Administration (FDA) for the treatment of **neovascular age-related macular degeneration (AMD)**.  **[1121404_9d59eda1519c43b19c5d19bcdcccb3f3_0]** **[1121404_9d59eda1519c43b19c5d19bcdcccb3f3_1]** 
- This designation aims to **facilitate the development and expedite the review** of medicines for serious conditions with unmet medical needs.  **[1121404_9d59eda1519c43b19c5d19bcdcccb3f3_1]** 
- SAR402663 is currently being evaluated in a **phase 1/2 clinical study** and is designed to inhibit vascular endothelial growth factor (VEGF) and potentially **reduce treatment burden** for the **more than one million people in the US** affected by neovascular AMD.  **[1121404_9d59eda1519c43b19c5d19bcdcccb3f3_0]** **[1121404_9d59eda1519c43b19c5d19bcdcccb3f3_1]**

Sanofi's SAR402663 Earns US Fast Track Designation

- Sanofi's **Wayrilz** (rilzabrutinib) has received **US Food and Drug Administration (FDA) approval** for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.  **[1121404_0001193125-25-194750_d52080dex991.htm:0]** 
- Wayrilz is the **first Bruton's tyrosine kinase (BTK) inhibitor** approved for ITP, addressing the root causes of the disease through multi-immune modulation.  **[1121404_0001193125-25-194750_d52080dex991.htm:0]** **[1121404_0001193125-25-194750_d52080dex991.htm:2]** 
- The approval, announced on **August 29, 2025**, was based on the pivotal **LUNA 3 phase 3 study**, which demonstrated a positive impact on sustained platelet counts and other ITP symptoms.  **[1121404_0001193125-25-194750_d52080dex991.htm:0]** 
- Wayrilz was also approved in the **United Arab Emirates** in June 2025 and is currently under regulatory review for ITP in the **EU and China**.  **[1121404_0001193125-25-194750_d52080dex991.htm:1]**

Sanofi's Wayrilz Receives US FDA Approval

- Regeneron's investigational **cemdisiran monotherapy** met primary and key secondary endpoints in the Phase 3 NIMBLE trial for adults with generalized myasthenia gravis (gMG).  **[1121404_9df90e83287a423bae613848a2859eb4_0]** 
- Cemdisiran monotherapy demonstrated a **2.3-point placebo-adjusted improvement** in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score.  **[1121404_9df90e83287a423bae613848a2859eb4_0]** 
- The U.S. regulatory submission for cemdisiran monotherapy is planned for the **first quarter of 2026**, pending discussions with the FDA.  **[1121404_9df90e83287a423bae613848a2859eb4_0]** 
- Cemdisiran monotherapy is dosed **subcutaneously every three months** and showed a favorable safety profile, with serious treatment-emergent adverse events occurring in **3%** of patients.  **[1121404_9df90e83287a423bae613848a2859eb4_0]** **[1121404_9df90e83287a423bae613848a2859eb4_2]**

Sanofi (SNY)