Sanofi

Sanofi engages in the research, production, and distribution of pharmaceutical products. It operates through the following business segments: Pharmaceuticals, Consumer Healthcare, and Vaccines. The Pharmaceuticals segment comprises the commercial operations of the following global franchises: specialty care, diabetes and cardiovascular, established prescription products and generics, and research, development, and production activities. The Consumer Healthcare segment includes the commercial operations for its Consumer Healthcare products. The Vaccines segment consists commercial operations of Sanofi Pasteur. The company was founded in 1973 and is headquartered in Paris, France.

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Regeneron Pharmaceuticals

Regeneron Pharmaceuticals and Sanofi have won FDA expanded approval of their blockbuster anti-inflammatory drug Dupixent in chronic obstructive pulmonary disease.

Regeneron, Sanofi Get FDA OK for Dupixent to Treat COPD

The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease commonly known as "smoker's lung", the companies said on Friday.

US FDA approves Sanofi-Regeneron's Dupixent for 'smoker's lung'

Dupixent approved in the US as the first-ever biologic medicine for patients with COPD          Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo Dupixent is the leading biologic medicine for all of its FDA-approved indications in new-to-brand prescriptions, and the most prescribed biologic by pulmonologists in the US Paris and Tarrytown, NY, September 27, 2024. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Press Release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent approved in China as the first-ever biologic medicine for patients with COPD Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function, and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government's Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory and dermatological diseases in China Paris and Tarrytown, New York, Sept. 27, 2024. The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.

Press Release: Dupixent approved in China as the first-ever biologic medicine for patients with COPD

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Are Investors Undervaluing Sanofi (SNY) Right Now?

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Availability of the Q3 2024 Aide mémoire Paris, France – September 26, 2024. Sanofi announced today that its Q3 2024 Aide mémoire is available on the "Investors" page of the company's website: Third quarter 2024 results (sanofi.com) As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results.

Press Release: Availability of the Q3 2024 Aide mémoire

Sanofi has received two separate bids for its consumer health unit, which could be valued at 15 billion euros ($16.74 billion) or more, from private equity firms Clayton Dubilier & Rice and PAI Partners, Bloomberg News reported on Tuesday.

Sanofi gets two bids valuing its consumer health unit at about $17 billion, Bloomberg News reports

Ventyx Biosciences

On Monday, Sanofi SA SNY agreed to make a $27 million strategic investment in Ventyx Biosciences Inc VTYX.

Sanofi Injects $27M In Neurology Drug Developer Ventyx Biosciences

This latest FDA decision marks the first approval for SNY's Sarclisa as a first-line treatment for multiple myeloma patients.

Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma

Sanofi Chief Executive Paul Hudson said on Monday that the company has not made a final decision yet on how it plans to split off its Opella consumer healthcare unit, but that it is interested in keeping a stake in the business after the separation is done.

Sanofi CEO still considering how to split consumer biz, hopes to keep a stake

Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant

Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant

Sanofi won approval for the use of a drug combination with its Sarclisa infusion to treat certain types of newly diagnosed multiple myeloma, where it has previously been used only after standard treatments have failed, the U.S. Food and Drug Administration said on Friday.

Sanofi wins US approval for drug combination to treat multiple myeloma

Sanofi (NASDAQ:SNY ) ECTRIMS 2024 Investor Science Call September 20, 2024 10:00 AM ET Company Participants Thomas Kudsk - IR Jiwon Oh - MD, PhD, St. Michael's Hospital, University of Toronto, Toronto, Canada Robert Fox - MD, Mellen Center for MS, Cleveland Clinic, Cleveland, USA Houman Ashrafian - EVP, Head of Research and Development Erik Wallstroem - Global Senior VP, Head, Neurology Development Conference Call Participants Peter Verdult - Citi Colin Wyatt - Jefferies Luisa Hector - Berenberg Emily Field - Barclays Simon Baker - Atlantic Redburn Richard Vosser - JPMorgan Emmanuel Papadakis - Deutsche Bank Graham Parry - Bank of America Seamus Fernandez - Guggenheim Peter Verdult - Jefferies Eric Berrigaud - Stifel Nicolaus Thomas Kudsk Good afternoon from Copenhagen, and welcome to the Sanofi Investor Science Call from the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis or ECTRIMS 2024. I'm Thomas Kudsk from the Investor Relations team at Sanofi and we are here today for an update on Tolebrutinib, Sanofi's new medicine, intending to benefit patients with certain forms of multiple sclerosis.

Sanofi (SNY) ECTRIMS 2024 Investor Science Call Transcript

Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group Paris and Tarrytown, NY, September 20, 2024. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age.

Press Release: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old

Sanofi said on Friday that its multiple sclerosis drug candidate was shown to delay worsening of a progressive form of the disease by 31%, as the French drugmaker eyes a request for approval later this year.

Sanofi says tolebrutinib drug delayed progressive MS by 31%

Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study

Press Release: Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study

SNY's reasonable valuation, rising estimates, improving top line and positive pipeline progress are good enough reasons to stay invested in the stock.

Sanofi Stock Up Almost 23% in 3 Months: Buy, Sell or Hold?

Sanofi said on Monday the U.S. Food and Drug Administration has approved a manufacturing line for its and partner AstraZeneca's preventive respiratory syncytial virus (RSV) therapy.

US FDA approves manufacturing line for Sanofi's preventive RSV therapy

Company planning for every eligible baby in the US to have access to BEYFORTUS New BEYFORTUS filling line approved by the U.S. Food and Drug Administration (FDA) to expand manufacturing capacity and help meet demand 2 out of 3 babies get respiratory syncytial virus (RSV) disease1 BRIDGEWATER, N.J. , Sept. 16, 2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to help ensure the majority of doses are available ahead of RSV season.

Sanofi shipping BEYFORTUS® in US to help protect babies against RSV disease; new manufacturing line approved by FDA

Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers Paris, France, and Houston, Texas, September 12, 2024. As part of its effort to develop innovative treatments for people living with rare cancers, Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US clinical-stage biotechnology company developing radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) against unmet medical needs in cancer, and Orano Med, a French clinical-stage biotechnology company, subsidiary of the Orano Group, developing lead-212 (212Pb) radioligand therapies (RLTs) against cancer.

Press Release: Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers

This is the second pivotal late-stage study on SNY/REGN's Dupixent in chronic spontaneous urticaria indication to meet primary and key secondary endpoints.

Sanofi, Regeneron's Dupixent Meets Late-Stage Urticaria Study Goals

Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU Confirming the results of CUPID-A, this second pivotal study in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistamines Data will support regulatory resubmission in the US by year-end; if approved, Dupixent would be the first targeted therapy for CSU in a decade Paris and Tarrytown, NY, September 11, 2024. A Dupixent (dupilumab) confirmatory phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines.

Press Release: Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU

Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study Study met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union Paris and Tarrytown, NY, September 11, 2024. A Dupixent (dupilumab) pivotal study (ADEPT) in bullous pemphigoid (BP) met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe disease.

Press Release: Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study

The pharmaceutical-sector mainstay published news about its investigational multiple sclerosis drug. It did well in one trial but was less impressive in two others.

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