Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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October 2024
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Key Release
Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile
Ad hoc announcement pursuant to Art. 53 LR Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III… -
Key Release
Novartis continues strong momentum in Q3 with 10% sales growth, 20% core operating income growth, and important innovation milestones; raises FY 2024 guidance
Ad hoc announcement pursuant to Art. 53 LRQ3 net sales grew +10% (cc1, +9% USD) with core operating income up +20% (cc, +17% USD) Sales growth driven by continued strong performance from Entresto (+… -
Media Release
Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial
New APPEAR-C3G data show Fabhalta sustained proteinuria reduction at 12 months1Upon Fabhalta initiation, improvement observed in estimated glomerular filtration rate (eGFR) slope – a key measure of… -
Media Release
Novartis ribociclib (Kisqali®) recognized as Category 1 preferred breast cancer adjuvant treatment by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
Ribociclib (Kisqali) plus aromatase inhibitor (AI) recommended for HR+/HER2- early breast cancer (EBC) node-positive and high-risk node-negative patients, as studied in the NATALEE trial and… -
Media Release
Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant…
September 2024
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Media Release
New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients
Nearly 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… -
Key Release
FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer
Ad 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… -
Media Release
Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancer
Invasive 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 Release
Novartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD risk
Phase 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… -
Key Release
Novartis 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,…