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 reported **Q3 2025 sales growth of 7.0% at constant exchange rates (CER)** and **business earnings per share (EPS) of €2.91**, representing a 13.2% increase at CER.  **[1121404_3651034ab44a4c2099936f40f58e9d68_0]** 
- Sales were significantly driven by **Dupixent, which grew by 26.2% to €4.2 billion**, and **Pharma launches, which increased sales by 57.1% to €1.0 billion**.  **[1121404_3651034ab44a4c2099936f40f58e9d68_0]** 
- The company made pipeline progress with **two regulatory approvals** (Wayrilz in the US and Tzield in China) and **two positive phase 3 readouts** for amlitelimab and Fluzone HD.  **[1121404_3651034ab44a4c2099936f40f58e9d68_0]** **[1121404_3651034ab44a4c2099936f40f58e9d68_1]** 
- Sanofi completed the **Vigil Neuroscience acquisition** and is on track to complete its **€5 billion share buyback program in 2025**, with **86.1% executed to date**.  **[1121404_3651034ab44a4c2099936f40f58e9d68_0]** **[1121404_3651034ab44a4c2099936f40f58e9d68_1]** 
- The company **reiterated its 2025 guidance**, expecting high single-digit sales growth and low double-digit business EPS growth at CER.  **[1121404_3651034ab44a4c2099936f40f58e9d68_0]** **[1121404_3651034ab44a4c2099936f40f58e9d68_1]**

Sanofi Reports Strong Q3 2025 Sales and EPS Growth

- Electra Therapeutics, a clinical-stage biotechnology company, announced an **oversubscribed $183 million Series C financing** round.  **[1121404_52e674a34f664fbcb67fc1d20b7961b4_0]** 
- The financing was **co-led by Nextech and EQT Life Sciences**, with new investors including **Sanofi**, HBM Healthcare Investments, and Mubadala Capital.  **[1121404_52e674a34f664fbcb67fc1d20b7961b4_0]** 
- Proceeds will fund a global pivotal Phase 2/3 study of **ELA026** for secondary hemophagocytic lymphohistiocytosis (sHLH) and support its expansion into hematologic cancers.  **[1121404_52e674a34f664fbcb67fc1d20b7961b4_0]** 
- The funding will also advance **ELA822**, Electra's second SIRP-targeted program, into clinical trials for immunology and inflammation.  **[1121404_52e674a34f664fbcb67fc1d20b7961b4_0]** 
- **Thomas Geninatti, PhD from Nextech**, will join Electra’s board of directors, and **Christoph Broja from EQT Life Sciences** will join as a board observer.  **[1121404_52e674a34f664fbcb67fc1d20b7961b4_1]**

Electra Therapeutics Announces $183 Million Series C Financing

- Sanofi's efdoralprin alfa met **all primary and key secondary endpoints** in the **ElevAATe phase 2 study** for alpha-1 antitrypsin deficiency (AATD) emphysema.  **[1121404_35ca3cc385ce453399819b6e80f15119_0]** **[1121404_35ca3cc385ce453399819b6e80f15119_1]** 
- The investigational therapy demonstrated **superiority** over a standard of care plasma-derived therapy by achieving a statistically significant greater mean increase in functional AAT levels.  **[1121404_35ca3cc385ce453399819b6e80f15119_0]** **[1121404_35ca3cc385ce453399819b6e80f15119_1]** 
- Efdoralprin alfa supports **less frequent dosing (every three or four weeks)**, offering a potentially significant improvement in convenience compared to weekly plasma-derived therapy.  **[1121404_35ca3cc385ce453399819b6e80f15119_0]** **[1121404_35ca3cc385ce453399819b6e80f15119_1]** 
- The drug was **well tolerated** with a similar adverse event profile to plasma-derived therapy and has received **Fast Track and Orphan Drug designation** from the FDA for AATD emphysema.  **[1121404_35ca3cc385ce453399819b6e80f15119_1]** **[1121404_35ca3cc385ce453399819b6e80f15119_2]**

Sanofi announces positive Phase 2 results for efdoralprin alfa

- Sanofi's Efluelda/Fluzone High-Dose influenza vaccine demonstrated **superior protection** against hospitalization in adults 65 years and over compared to standard-dose vaccines, according to new data from the FLUNITY-HD study published on **October 17, 2025**.  **[1121404_f9c5f0418f5f40009f50ff674b0bae99_0]** 
- The study, published in The Lancet, found a **31.9% additional reduction** in laboratory-confirmed influenza hospitalizations and **8.8% additional protection** against pneumonia/influenza hospitalizations.  **[1121404_f9c5f0418f5f40009f50ff674b0bae99_0]** 
- The high-dose vaccine also provided **2.2% additional protection** against all-cause hospitalizations, meaning one additional hospitalization could be averted for every **515 individuals** vaccinated with Efluelda instead of standard-dose.  **[1121404_f9c5f0418f5f40009f50ff674b0bae99_0]** **[1121404_f9c5f0418f5f40009f50ff674b0bae99_1]** 
- This marks the **first time a vaccine has demonstrated superior protection** against both influenza infection and hospitalizations in individually randomized studies for older adults.  **[1121404_f9c5f0418f5f40009f50ff674b0bae99_0]**

Sanofi's high-dose influenza vaccine demonstrates superior protection against hospitalization in older adults

- **Sanofi** announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a **negative opinion** on the marketing authorization application for **Rezurock (belumosudil)** for the third-line treatment of chronic graft-versus-host disease (cGVHD) in the EU.  **[1121404_296d7a0b6e784c75b5773e0c1f84cc58_0]** 
- Sanofi plans to **seek a re-examination** of the CHMP opinion, expressing confidence in Rezurock's clinical and real-world evidence.  **[1121404_296d7a0b6e784c75b5773e0c1f84cc58_0]** 
- **Rezurock** is currently approved in **20 countries**, including the US, UK, and Canada, and has been prescribed to over **17,000 patients** worldwide since its initial US approval in July 2021.  **[1121404_296d7a0b6e784c75b5773e0c1f84cc58_0]**

Sanofi receives negative EU regulatory opinion for Rezurock

- Sanofi's investigational somatostatin receptor (SSTR)-Targeted Alpha Therapy, **AlphaMedix TM (212Pb-DOTAMTATE)**, achieved all primary efficacy endpoints in its **ALPHAMEDIX-02 phase 2 study**.  **[1121404_0001193125-25-239836_d10882d6k.htm:0]** **[1121404_0001193125-25-239836_d10882dex991.htm:0]** 
- The study demonstrated **clinically meaningful overall response rates** and prolonged clinical benefits in both PRRT-naïve and PRRT-exposed patients with unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs), with a manageable safety profile.  **[1121404_0001193125-25-239836_d10882dex991.htm:0]** 
- These positive results will form the basis of **future discussions with health authorities** for AlphaMedix TM, which received **Breakthrough Therapy Designation from the US FDA** in February 2024.  **[1121404_0001193125-25-239836_d10882dex991.htm:0]**

Sanofi Announces Positive Phase 2 Results for AlphaMedix TM in GEP-NETs

- Regeneron's investigational gene therapy **DB-OTO** for profound genetic hearing loss demonstrated that **11 out of 12 participants experienced clinically meaningful hearing improvements**, with **3 achieving normal hearing levels**.  **[1121404_c14160e24226485d8a531f2eaf3bc50c_0]** 
- **9 participants met the primary endpoint** of hearing improvements at a threshold of ≤70 decibel hearing level (dBHL) at week 24, and **all 3 participants who completed speech assessments showed significant improvement**.  **[1121404_c14160e24226485d8a531f2eaf3bc50c_1]** 
- The treatment was **well tolerated**, with no DB-OTO-related adverse findings reported across all 12 participants.  **[1121404_c14160e24226485d8a531f2eaf3bc50c_1]** 
- A **U.S. regulatory submission for DB-OTO is planned for later this year**, pending discussions with the FDA, and it has received multiple FDA designations including Orphan Drug and Fast Track.  **[1121404_c14160e24226485d8a531f2eaf3bc50c_1]**

Regeneron announces DB-OTO trial results

- The U.S. Food and Drug Administration (FDA) has approved **Regeneron's Libtayo® (cemiplimab-rwlc)** as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.  **[1121404_5682578f3f9f4f88a77e6da52464c4b0_0]** 
- This approval establishes Libtayo as the **first and only immunotherapy** approved in the adjuvant setting for this patient population.  **[1121404_5682578f3f9f4f88a77e6da52464c4b0_1]** **[1121404_5682578f3f9f4f88a77e6da52464c4b0_0]** 
- The FDA approval was based on data from the pivotal Phase 3 C-POST trial, which demonstrated that Libtayo significantly reduced the risk of disease recurrence or death by **68%** compared to placebo.  **[1121404_5682578f3f9f4f88a77e6da52464c4b0_0]** 
- An additional regulatory application for Libtayo in this indication is currently under review in the European Union, with a decision expected by the first half of **2026**.  **[1121404_5682578f3f9f4f88a77e6da52464c4b0_0]**

Regeneron's Libtayo Receives FDA Approval for Adjuvant CSCC Treatment

- **Bioxodes SA** has appointed **Philippe Monteyne, MD, PhD**, as chairman of its Board of Directors.  **[1121404_0734d210054f4d6780daf218d38e3d12_1]** 
- Dr. Monteyne, a former **GSK** and **Sanofi** executive, brings extensive experience in drug development, including leading the development of **Cervarix®**, and a decade of experience as a venture capitalist.  **[1121404_0734d210054f4d6780daf218d38e3d12_0]** **[1121404_0734d210054f4d6780daf218d38e3d12_1]** 
- This appointment strengthens Bioxodes' leadership following encouraging **Phase 2a interim data** for its lead candidate, **BIOX-101**, in intracerebral hemorrhage.  **[1121404_0734d210054f4d6780daf218d38e3d12_0]** **[1121404_0734d210054f4d6780daf218d38e3d12_2]** 
- A **Phase 2b trial** for BIOX-101 is scheduled to begin in **2027**, which could be sufficient for conditional marketing authorization in the U.S. and Europe, with potential commercialization as early as **2030**.  **[1121404_0734d210054f4d6780daf218d38e3d12_0]** **[1121404_0734d210054f4d6780daf218d38e3d12_1]**

Bioxodes Appoints Philippe Monteyne as Chairman

- **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 (SNY)