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September 2024
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Media ReleaseNew Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patientsNearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study1More than 80…
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Key ReleaseFDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancerAd hoc announcement pursuant to Art. 53 LR Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4…
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Media ReleaseNovartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancerInvasive disease-free survival benefit continued to increase after completion of the three-year treatment period across all patient subgroups, including those with node-negative disease1Results…
August 2024
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Media ReleaseNovartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD riskPhase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C reduction1 Results add to growing body of…
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Key ReleaseNovartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)Ad hoc announcement pursuant to Art. 53 LR Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm,…
July 2024
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Media ReleaseNovartis Scemblix® granted FDA Priority Review for the treatment of adults with newly diagnosed CMLPriority Review based on ASC4FIRST Phase III study with Scemblix® data first to show significantly improved molecular response and a favorable safety and tolerability profile compared to standard of…
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Key ReleaseNovartis continues to deliver strong sales growth and core margin expansion in Q2; raises FY 2024 bottom-line guidanceAd hoc announcement pursuant to Art. 53 LRQ2 net sales grew +11% (cc1, +9% USD) with core operating income up +19% (cc, +17% USD) Sales growth driven by continued strong performance from Entresto (+…
May 2024
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Media ReleaseLatest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative diseaseAddition of Kisqali® (ribociclib) to endocrine therapy (ET) demonstrated a 28% risk reduction in invasive disease-free survival (iDFS) in subgroup of patients with node-negative (N0) disease at…
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Media ReleaseNovartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CMLPhase III ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results; Scemblix® (asciminib) demonstrated superior MMR rates at week 48 vs.…
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Media ReleaseNovartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticariaPatients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and sustained to 1 year (Week 52)1Remibrutinib, an oral Bruton’s…
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Media ReleaseNovartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolioIn the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (…
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Media ReleaseNovartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placeboSecondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo1; additional 6-month open-label data to be presented at a future medical…
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