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 ...

Sanofi's (SNY) stock has gained 22.7% in the past three months compared with an increase of 2.9% for the industry. The stock has also outperformed the sector and the S&P 500 index as seen in the chart below. SNY Stock Outperforms Industry, Sector & S&P 500 Image Source: Zacks Investment Research The stock has also been consistently trading above its 50-day and 200-day moving averages since the end of June. One of the main reasons for the stock price increase in the past three months was Sanofi's increase in ...

Regeneron Pharmaceuticals, Inc. (REGN) announced that the FDA has approved blockbuster drug Dupixent (dupilumab) for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP) for a broader population. The regulatory body approved the drug as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP. The latest approval expands the initial FDA approval (granted in June 2019) in CRSwNP for patients aged 18 years and older. Regeneron's shares have ...

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 ...

Sanofi (SNY) and Regeneron (REGN) announced encouraging data from the confirmatory phase III LIBERTY-CUPID C study evaluating their blockbuster drug Dupixent (dupilumab) in chronicspontaneous urticaria (CSU) indication. Results Confirm Significant Improvement in Itch & Hives The LIBERTY-CUPID C study enrolled CSU patients aged six years and older who remained symptomatic despite standard-of-care (SOC) antihistamines and were not previously treated with Novartis (NVS) /Roche's (RHHBY) Xolair (omalizumab). Th ...

EXTON, PA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Since its 2017 debut as the first advanced systemic treatment for atopic dermatitis (AD), Sanofi/Regeneron's Dupixent has dominated the US market. However, the introduction of LEO Pharma's Adbry, Pfizer's Cibinqo, and AbbVie's Rinvoq has started to disrupt the treatment landscape. While Dupixent still holds the highest market share by a significant margin, its dominance is gradually diminishing with the rising adoption of these newer treatments and is expected t ...

Investors found something to like about the company's recent round of clinical trials for a key pipeline medication. Although the latest news from the laboratory was mixed for pharmaceutical company Sanofi (SNY 2.26%) on Tuesday, investors gave the company the benefit of the doubt. They bid the share price up by more than 2% on the day, making it a mirror image of the 2%-plus decline of the S&P 500 index. 1 out of 3 trials was a success Sanofi published readouts of three phase 3 trials of its tolebrutinib m ...

Sanofi (SNY) announced that a phase III study evaluating its investigational oral BTK inhibitor, tolebrutinib, demonstrated clinically meaningful benefit in disability accumulation in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). The HERCULES phase III study met the primary endpoint by showing an improvement over placebo in delaying time to onset of confirmed disability progression. There are no approved therapies to treat nrSPMS at present. Multiple sclerosis (MS) is a chro ...