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 ...

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 (R ...

SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced the pricing of an underwritten offering of 2,750,498 shares of its common stock at a price of $36.50 per share, representing a premium of approximately 10% to Anaptys' closing price on Aug. 13, 2024. The gross proceeds from this offering are expected to be approximately $100 million, before deducting underwriting discou ...

Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant Sarclisa (isatuximab) in combination with standard-of-care lenalidomide, bortezomib, and dexamethasone (RVd) during 18-week induction treatment followed by transplant resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared to RVd induction therapy, regardless of maintenance therapy assi ...

Thank you very much Shirley. A few elements in your question. First point, I understood you were questioning on the partnership with Novavax and more specifically about the combination vaccines where we have, you understood very well, we really want to make sure that there is no compromise, neither on safety or efficacy, and we believe that a combination is only worth if you're at least as good or better than the best standalone products separately. That's exactly what we want to do with the combination vac ...

Debt and Financial Position - As of June 30, 2024, total debt increased to €21,918 million from €16,531 million at the end of 2023, with net debt rising to €15,112 million from €7,793 million[5]. - Long-term debt decreased to €12,503 million from €14,347 million, while short-term debt surged to €9,236 million from €2,045 million[5]. - Sanofi's total liabilities related to business combinations and non-controlling interests rose to €8,219 million from €7,602 million at the end of 2023[14]. - Sanofi's interest rate and currency derivatives used to manage debt increased to €179 million from €139 million[5]. - The market value of Sanofi's debt, net of cash and cash equivalents, was €14,214 million as of June 30, 2024, compared to €7,086 million as of December 31, 2023[133]. - Sanofi had two syndicated credit facilities of €4 billion each, with one expiring in December 2027 and the other in March 2029, neither of which was drawn down as of June 30, 2024[158]. - As of June 30, 2024, Sanofi's total contingent consideration related to acquisitions amounted to €728 million, with €61 million classified as current[163]. Income and Revenue - Total net sales for the first half of 2024 reached €21,209 million, an increase from €20,187 million in the same period of 2023, representing a growth of 5.1%[60]. - Business operating income for the first half of 2024 was €5,656 million, down from €6,059 million in the first half of 2023, indicating a decrease of 6.6%[51]. - Total biopharma revenue for the first half of 2024 was €18,378 million, up from €17,467 million in the first half of 2023, marking a growth of 5.2%[48]. - Net income for the six months ended June 30, 2024, was €2,263 million, a decrease of 34.5% compared to €3,456 million for the same period in 2023[67]. - Operating income for the first half of 2024 was €3,044 million, compared to €4,322 million in the first half of 2023, representing a decrease of 29.5%[65]. - The total income before tax for the first half of 2024 was €2,739 million, down from €4,238 million in the same period of 2023, reflecting a decrease of approximately 35.3%[179]. Expenses and Costs - Research and development expenses for the first half of 2024 amounted to €3,423 million, compared to €3,193 million in the first half of 2023, reflecting an increase of 7.2%[60]. - Employee-related expenses surged to €849 million in the first half of 2024, significantly higher than €185 million in the same period of 2023[44]. - Restructuring costs and similar items for the first half of 2024 totaled €1,331 million, significantly higher than €547 million in the first half of 2023, indicating a rise of 143.5%[51]. - Financial expenses for the first half of 2024 were €586 million, compared to €370 million in the same period of 2023, indicating a rise of 58.5%[65]. - The company incurred a net cash outflow of €1,885 million for acquisitions of consolidated undertakings and investments accounted for using the equity method in the first half of 2024[102]. Cash and Equivalents - Sanofi's cash and cash equivalents decreased to €(6,795) million from €(8,710) million[5]. - Cash and cash equivalents decreased to €6,795 million as of June 30, 2024, down from €8,710 million at the end of 2023[58]. - Sanofi's cash and cash equivalents at the end of the period stood at €6,795 million, a decrease from €8,710 million at the beginning of the period, representing a decline of 22.0%[100]. Shareholder Information - The average number of shares outstanding was approximately 1,249.4 million, with basic earnings per share at €1.80, down from €2.74 in the previous year[65]. - The total number of shares outstanding as of June 30, 2024, was 1,266,362,756, with a share capital of €2,532,725,512[149]. - The company paid dividends of €3.76 per share for the year 2023, totaling €4,704 million[69]. - The average number of shares used to compute diluted earnings per share was 1,253.8 million for the first half of 2024, slightly down from 1,254.5 million in the same period of 2023[182]. Provisions and Liabilities - Provisions increased to €5,918 million in the first half of 2024, compared to €5,018 million in the same period of 2023[14]. - Sanofi's non-current provisions and other non-current liabilities increased to €8,219 million as of June 30, 2024, compared to €7,602 million at the end of 2023, an increase of 8.1%[92]. - Sanofi's provisions for pensions and other post-employment benefits totaled €2,214 million as of January 1, 2024, with total provisions increasing to €5,262 million by June 30, 2024[198]. Acquisitions and Collaborations - Sanofi entered a co-exclusive licensing agreement with Novavax, involving an upfront payment of $500 million and potential total payments of up to $1.2 billion[17]. - A collaboration agreement with Fulcrum Therapeutics for losmapimod includes an upfront payment of $80 million and potential milestone payments of up to $975 million[17]. - Sanofi completed the acquisition of Inhibrx for $2,035 million, with $1,908 million allocated to in-process development for SAR447537[139]. - Acquisitions of other intangible assets in the first half of 2024 totaled €772 million, including €463 million related to agreements with Novavax[142]. Other Financial Metrics - The company reported a gross profit of €15,649 million for the first half of 2024, compared to €15,198 million in the first half of 2023, an increase of 3.0%[60]. - Other comprehensive income for the period was €1,233 million, compared to a loss of €973 million in the same period last year[67]. - Comprehensive income for the first half of 2024 totaled €3,496 million, an increase from €2,483 million in the first half of 2023[67]. - Deferred tax assets increased to €780 million in the first half of 2024, compared to €441 million in the same period of 2023, indicating a significant rise of 76.9%[179]. Market and Economic Conditions - The cumulative inflation rate in Argentina and Turkey exceeded 100% over the last three years, leading Sanofi to treat these countries as hyperinflationary economies[108]. - The company has determined that its activities are not subject to significant seasonal fluctuations, indicating stable operational performance throughout the year[81]. - Currency translation differences on foreign subsidiaries resulted in a gain of €1,167 million for the first half of 2024, compared to a loss of €1,089 million in the same period of 2023[155].

XTEND-Kids is the first assessment of once-weekly ALTUVOCT® prophylaxis in previously treated children Results indicate highly effective bleed protection in children under 12 years of age with severe haemophilia A Published in NEJM, the pivotal XTEND-Kids study shows ALTUVOCT met primary and key secondary endpoints, which included occurrence of factor VIII inhibitors and annualised bleed rates (ABRs). Results revealed no development of factor VIII inhibitors and sustained protection from bleeding events wit ...