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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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

Regeneron Pharmaceuticals

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.

Why Sanofi Stock Was Robustly Healthy Today

Since my last article, Sanofi's stock price has continued to rise, thanks in part to strong sales of its immunology and oncology franchises. For example, Dupixent sales were €3.03 billion for the second quarter of 2024, up 28.9% year-on-year. Moreover, I expect demand for Dupixent to continue to grow, partly due to its approval in Europe for the treatment of people with uncontrolled chronic obstructive pulmonary disease.

Sanofi: A Long-Term Cash Cow With High Dividends

Sanofi's HERCULES phase III study on tolebrutinib meets primary endpoint, showing an improvement in delaying time to onset of confirmed disability progression.

SNY's MS Drug Meets Goal in One Phase III Study; Misses in Two Others

Sanofi's most advanced multiple sclerosis (MS) drug candidate has missed the main goal of two late-stage trials to treat relapsing forms of the disease, dimming the prospects for a widely-pursued class of drugs.

Sanofi MS drug tolebrutinib misses goal in relapsing disease trials

Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis In the HERCULES study, tolebrutinib met the primary endpoint in delaying time to onset of confirmed disability progression in people with nrSPMS, a population for which there are currently no approved therapies and significant unmet medical need The GEMINI 1 and 2 studies evaluating tolebrutinib in people with relapsing MS (RMS) did not show significance in the primary endpoint of reducing annualized relapse rate over Aubagio (teriflunomide). Analysis of the key secondary endpoint of pooled 6-month confirmed disability worsening (CDW) data showed a considerable delay in time to onset Phase 3 study results will form the basis for future discussions with global regulatory authorities Study results will be presented at the ECTRIMS medical meeting, September 20 Paris, September 2, 2024.

Press Release: Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis

AstraZeneca

GlaxoSmithKline

Johnson & Johnson

Eli Lilly

Merck

Novo Nordisk

Novartis

Pfizer

Roche Holding AG

In the ever-evolving pharmaceutical landscape, financial stability and business resilience are crucial for long-term success. S&P Global, a leading financial information firm, recently released a comprehensive report evaluating the world's top pharmaceutical companies based on their business and financial risk profiles.

Top 10 pharmaceutical companies in 2024: S&P Global's latest ratings and rankings

Rhythm Pharmaceuticals

A year ago, medical experts and Nobel Laureates interviewed by The New York Times proclaimed "a Golden Age of Medicine" is here.

Three Biotech Stocks to Buy for the "Golden Age of Medicine"

Vertex Pharmaceuticals

With the current market volatility, knowing which biotech stocks to buy on the dip can lead to lucrative returns as the industry is likely to recover faster than the market average. After all, many of the most prominent biomedical developers see their stock price rise or fall based on their drug success.

3 Biotech Stocks to Buy on the Dip: August 2024

Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant

Press Release: Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant

Ionis Pharma

AstraZeneca, Ionis and Sanofi are included in this Analyst Blog.

News for Sanofi Stock (SNY)