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Sanofi (SNY)
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All | News | Filings
| Date Filed | Type | Description |
| 10/11/2023 |
6-K
| Quarterly results |
| 09/27/2023 |
6-K
| Quarterly results |
| 08/10/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 07/28/2023 |
6-K
| Quarterly results |
| 07/28/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 07/28/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 07/24/2023 |
6-K
| Quarterly results |
| 07/05/2023 |
6-K
| Quarterly results |
| 06/02/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"6-K",
"Sandrine Guendoul | + 33 6 25 09 14 25 | [email protected]",
"Paris, May 31 2023. New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers annual meeting, demonstrate that frexalimab, Sanofi's novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase 2 trial of patients with relapsing multiple sclerosis . Following 12 weeks of therapy, the number of new gadolinium-enhancing T1-lesions",
"Paris, June 1 2023." |
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| 05/23/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 04/27/2023 |
6-K
| Quarterly results |
| 04/27/2023 |
6-K
| Quarterly results |
| 04/24/2023 |
6-K
| Quarterly results |
| 03/23/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"6-K",
"100% of commercially insured people are eligible for Sanofi's copay assistance programs, regardless of income or insurance plan design, which, in 2022 limited out-of-pocket expenses for a majority of participating patients to $15 or less for their diabetes medicines for a 30-day supply. ● 100% of uninsured people are eligible for the Insulins Valyou Savings Program - regardless of income level - enabling them to buy one or multiple Sanofi insulins at $35 for a 30-day supply. The Soliqua injection 100 Units/mL and 33 mcg/mL cash offer also allows uninsured people to pay as little as $99 per box of pens, for up to two boxes of pens for a 30-day supply. ● We also provide free medications to qualified low- and middle-income patients the Sanofi Patient Connection program . Some peop...",
"About the Dupixent Trial The Phase 3 double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 133 adolescents and adults with moderate-to-severe atopic hand and foot dermatitis who had an inadequate response or intolerance to topical corticosteroids. Patients with hand and foot disease predominantly driven by allergic or irritant contact dermatitis were excluded from the trial. The primary endpoint evaluated the proportion of patients with clear or almost clear skin of hand and feet eczema at 16 weeks . The key secondary endpoint measured the proportion of patients with improvement in itch on hands and feet from baseline at 16 weeks. Lesion sign reduction was assessed by change from baseline in Modified Total Lesion Sign Score , and disease severity was asses...",
"About the Pivotal Dupixent Atopic Dermatitis Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency TCS compared to low-potency TCS alone in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The co-primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 and 75% improvement in Eczema Area and Severity Index at week 16. Additional endpoints measured itch , sleep quality , skin pain and health-related quality of life . About Dupixent Dupixent is an injection administered under the skin at different injection sites. In patients aged 6 months to 5 years, Dupixent is administered with a pre-filled syringe ever...",
"About the Dupixent COPD Phase 3 Trial Program BOREAS is one of two pivotal trials in the Dupixent COPD program. The randomized, Phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 939 adults who were current or former smokers aged 40 to 80 years with moderate-to-severe COPD. All patients in the trial had evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells/µL. During the 52-week treatment period, patients received Dupixent or placebo every two weeks added to triple therapy of inhaled corticosteroids , long-acting beta agonists, and long-acting muscarinic antagonists. Double maintenance therapy was allowed if ICS was contraindicated. The primary endpoint evaluated the annualized rate of acute moderate or severe..." |
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| 03/14/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"6-K",
"Paris and Tarrytown, N.Y. March 7, 2023. The U.S. Food and Drug Administration has accepted, for review, the supplemental Biologics License Application for Dupixent ® to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023. CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin. Swelling, called angioedema, may occur most commonly on the face, hands and feet, but can also affect the throat and upper airways. CSU is typically treated with H1 antihistamines, medicines that target histamine-1 receptors on cells ..." |
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| 03/13/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
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"6-K",
"Kristen Keller | [email protected] Sanofi Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product, and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “will be”, “intends”, “estimates”, “plans” and similar ..." |
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| 03/06/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 02/24/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 02/03/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 01/31/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
|
"6-K",
"Sanofi Forward-Looking Statements",
"Paris and Tarrytown, N.Y. January 27, 2023. The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Dupixent ® , recommending expanded approval in the European Union to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.",
"About Eosinophilic Esophagitis EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 and interleukin-13 are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation of the esophagus may be needed. In severe cases, a feeding tube may be the only option..." |
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| 01/17/2023 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
|
"6-K",
"About Eosinophilic Esophagitis EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 and interleukin-13 are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation of the esophagus may be needed. In severe cases, a feeding tube may be the only option...",
"About nirsevimab In the U.S., nirsevimab is an investigational single-dose long-acting antibody designed to help protect all infants from birth through their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract infection caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease. 15 In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and...",
"Paris, January 11, 2023 Sanofi Ventures has announced an additional multi-year commitment from Sanofi, with an increase in capital to more than $750 million to the evergreen venture fund. In addition to serving as a financial partner to top-tier early-to-mid-stage portfolio companies, the fund supports future efforts for business development and M&A opportunities within Sanofi. The additional capital, confirmed by the executive committee, will also fuel the expansion and investment capacity of the Sanofi Ventures investment team on a global scale." |
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| 12/20/2022 |
6-K
| Quarterly results |
| 12/02/2022 |
6-K
| Quarterly results |
| 11/21/2022 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 11/15/2022 |
6-K
| Quarterly results |
| 11/10/2022 |
6-K
| Quarterly results |
| 10/28/2022 |
6-K
| Quarterly results |
| 10/17/2022 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 10/03/2022 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 09/22/2022 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 09/12/2022 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:|
Docs:
|
"6-K",
"Paris, September 5, 2022. The Board of Directors of Sanofi met on September 2, 2022 and unanimously appointed Frédéric Oudéa as ‘Censeur' (non-voting",
"About Pediatric Asthma Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require the use of multiple courses of systemic corticosteroids that carry significant risks. About the LIBERTY ASTHMA EXCURSION Trial The Phase 3, multicenter, open-label extension trial evaluated the long-term safety and efficacy of Dupixent in 365 children with uncontrolled moderate-to-severe asthma who had previously participated in the placebo-controlled VOYAGE trial when t...",
"About Prurigo Nodularis People with prurigo nodularis experience intense, persistent itch, with thick skin lesions that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. About the Trial PRIME, part of the LIBERTY-PN PRIME clinical program, was a randomized, Phase 3, double-blind, placebo-controlled trial that evaluated the..." |
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| 09/02/2022 |
6-K
| Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]: |
| 08/17/2022 |
6-K
| Quarterly results |
| 08/11/2022 |
6-K
| Quarterly results |
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