Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (“CSU”) in adults and adolescents aged 12 years and above, who remain symptomatic despite histamine-1 (H1) antihistamine treatment.Following the latest FDA nod, Dupixent became the first new targeted therapy to be approved for CSU in more than a decade. The drug is now approved for seven type II inflammatory diseases in the United States.Dupixent is already approv ...

Core Viewpoint - Sanofi announced preliminary data from the phase II TIDE-Asthma study for its anti-OX40L mAb, amlitelimab, which showed mixed results in treating moderate-to-severe asthma, alongside updates on other respiratory pipeline candidates [1][2][3]. Group 1: Amlitelimab Study Results - The highest dose of amlitelimab did not meet the primary endpoint of annualized exacerbation rate at week 48, while the medium dose showed nominal significance [2]. - At week 60, the medium dose demonstrated clinically meaningful reductions in asthma exacerbations, with a greater reduction observed at the high dose level [3]. - Amlitelimab also led to significant improvements in lung function and asthma control, which were secondary endpoints of the study [3]. Group 2: Other Respiratory Pipeline Developments - Sanofi is developing itepekimab in partnership with Regeneron Pharmaceuticals, currently in two phase III studies for chronic rhinosinusitis with nasal polyps [5]. - Itepekimab is also being evaluated for chronic obstructive pulmonary disease (COPD), with data expected in the second half of 2025 [6]. - Additional studies are ongoing for itepekimab in bronchiectasis and for lunsekimig in high-risk asthma and moderate-to-severe asthma, with data from these studies anticipated in 2026 [8][9]. Group 3: Market Performance - Year to date, Sanofi's shares have increased by 4.9%, contrasting with a 4.9% decline in the industry [4].

Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthmaLunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthmaItepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025 and bronchiectasis in 2026 Paris, April 15, 2025. Sanofi today shared new progress from its mid- to late-stage respiratory ...

One stock that might be an intriguing choice for investors right now is Sanofi (SNY) . This is because this security in the Large Cap Pharmaceuticals space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective. This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the Large Cap ...

Sanofi (SNY) announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).The candidate is being developed in separate mid-stage studies for treating wAIHA and IgG4-RD, two rare diseases.Currently, there are no approved therapies for treating wAIHA and IgG4-RD. Both diseases have a significant unmet medical need.The FDA grants orphan drug designation to support ...

The U.S. Food and Drug Administration (FDA) on Thursday granted orphan drug designation to Sanofi SA‘s SNY rilzabrutinib.The treatment is an investigational, novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).The FDA grants orphan drug designation to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the US.Rilzabrutinib ...

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related diseaseRilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia  Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK) in ...

Sanofi (SNY) announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults. The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.The FDA filing is supported by data from three late-stage studies — one ( ...

Core Viewpoint - The US FDA has granted fast track designation to Sanofi's mRNA vaccine candidate aimed at preventing chlamydia infection, highlighting its potential to address a significant public health need [1][2]. Group 1: Vaccine Development - The chlamydia vaccine candidate is designed to protect against primary genital tract infection and reinfection by Chlamydia trachomatis, with a phase 1/2 clinical study set to evaluate its immunogenicity and safety in adults aged 18 to 29 years [2][8]. - The development of this vaccine is part of the Translational Science Hub, a collaboration involving the Queensland Government, Griffith University, and the University of Queensland, connecting researchers in Australia with Sanofi scientists [5]. Group 2: Public Health Impact - Chlamydia is a prevalent bacterial infection with 129 million cases reported globally in 2020 among adults aged 15-49, particularly affecting adolescents and young adults [3][4]. - Over 80% of chlamydia cases are asymptomatic, leading to untreated infections and unintentional transmission, underscoring the urgent need for a vaccine [4]. Group 3: Company Overview - Sanofi is an innovative global healthcare company focused on improving lives through scientific advancements, providing life-changing treatments and vaccines while emphasizing sustainability and social responsibility [6].

Sanofi (SNY) announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults. The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.The FDA filing is supported by data from three late-stage studies — one ( ...