Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA has approved their blockbuster drug, Dupixent, for its sixth indication — chronic obstructive pulmonary disease (COPD) — in the United States. The approved indication is as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype. With this approval, Dupixent became the first biologic treatment approved for COPD in the United States. Dupixent was approved for treating COPD with raised blood eosi ...

On Friday, the FDA approved Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA's SNY Dupixent (dupilumab) as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, generally known as "smoker's lung." Dupixent is the first biologic medicine approved in the U.S. to treat these patients. Also Read: Sanofi, Regeneron Drug Dupixent Shows Successful Treatment Of Patients With Inflammatory Skin Disease. The FDA approval is based on dat ...

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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. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's thi ...

Regeneron Pharmaceuticals, Inc. (REGN) announced that the blockbuster asthma drug Dupixent (dupilumab) has been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") for approval for an additional indication. The CHMP recommended the label expansion of Dupixent in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for children aged 1 to 11 years who weigh at least 15 kg and are inadequately cont ...

Sanofi (SNY) announced that the FDA has approved the label expansion for the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod, Sarclisa is now approved in combination with Velcade (bortezomib), Bristol Myers' (BMY) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant (ASCT). The FDA's approval is based on data from the phase III IMROZ study, which evaluated Sarclisa plus ...

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 Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival (PFS), compared to standard-of-care in newly diagnosed adult patients not eligible for autologous stem cell transpl ...

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 ...

Company and Industry Key Points **1. Tolebrutinib Phase 3 Data**: * **GEMINI 1 and 2 Trials**: Phase 3 trials evaluating Tolebrutinib in relapsing MS compared to Teriflunomide. No significant difference in annualized relapse rate, but a 29% risk reduction in confirmed disability worsening at six months with Tolebrutinib vs. Teriflunomide [7-13]. * **HERCULES Trial**: Phase 3 trial evaluating Tolebrutinib in non-relapsing secondary progressive MS. 31% risk reduction in time to six-month confirmed disability progression and 88% increase in six-month confirmed disability improvement vs. placebo [21-25]. * **Liver Safety**: 5.6% of Tolebrutinib-treated patients experienced liver enzyme elevation >3x upper limit of normal. All cases resolved without sequelae and occurred within the first 90 days of treatment [17-19, 27-28]. **2. Tolebrutinib's Mechanism of Action**: * Tolebrutinib appears to have a clear effect on reducing disability accumulation, independent of relapse rate or focal inflammatory disease. This suggests a potential for a new standard of care in SPMS [18, 20, 30]. **3. Frexalimab**: * Frexalimab, a CD40-Ligand inhibitor, is being investigated for MS. Phase 2 data shows promising results with low ARR and stable EDSS [36-37]. **4. Sanofi's Commitment to MS**: * Sanofi has a strong commitment to MS and is developing a comprehensive portfolio of treatments, including Tolebrutinib, Frexalimab, and other molecules [33-37]. Additional Important Points **1. Regulatory Approval**: * Sanofi plans to submit regulatory filings for Tolebrutinib in SPMS and is working on FDA labeling strategies [76-77]. **2. Patient Access**: * Sanofi aims to accelerate approval and make Tolebrutinib available to patients as soon as possible [32, 33]. **3. Future Research**: * Sanofi plans to conduct further research on Tolebrutinib and Frexalimab, including subgroup analyses and studies in other MS populations [95-97].

Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study Data presented at ECTRIMS show that tolebrutinib, a brain-penetrant BTK inhibitor, addresses disability accumulation that occurs independently from relapse activity Global regulatory submissions will begin in H2 2024 Paris, September 20, 2024. Positive results from the HERCULES phase 3 study in people with non-relapsing secondary progressive multi ...