Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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April 2023
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Media ReleaseNovartis to present new data across oncology portfolio including Kisqali Phase III NATALEE trial in early breast cancer at ASCOPrimary analysis of NATALEE, the first and only positive Phase III study of a CDK4/6 inhibitor in a broad population of patients with stage II and III HR+/HER2- early breast cancer at risk of…
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Media ReleaseNovartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patientsData at EBMT show primary endpoint met – estimated* 92.2% of complement-inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH) achieving 2 g/dL or more hemoglobin-level increase…
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Key ReleaseNovartis delivers strong sales growth, robust margin expansion and major innovation milestones. Raises FY guidanceAd hoc announcement pursuant to Art. 53 LR Q1 sales grew +8% (cc1, +3% USD) and core operating income grew +15% (cc, +8% USD) Innovative Medicines (IM) sales grew +7% (cc, +3% USD) and core…
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Media ReleaseNovartis presents new five-year data on disability outcomes and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosisThe ALITHIOS open-label extension study showed continuous treatment with Kesimpta® (ofatumumab) for up to five years in relapsing multiple sclerosis (RMS) patients was associated with reduced risk of…
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Media ReleaseSandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulationBiosimilar Hyrimoz® (adalimumab) citrate-free high-concentration formulation (HCF) is now approved in the EU for use in all indications of reference medicine Humira®*HCF formulation adalimumab offers…
March 2023
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Media ReleaseNovartis Entresto receives positive CHMP opinion for pediatric heart failureIf subsequently approved, Entresto will be the first and only approved therapy for the treatment of symptomatic chronic heart failure patients aged 1 to <18 years in the European Union Pediatric…
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Key ReleaseNovartis Kisqali® Phase III NATALEE trial meets primary endpoint at interim analysis demonstrating clinically meaningful benefit in broad population of patients with early breast cancerAd hoc announcement pursuant to Art. 53 LR Kisqali plus endocrine therapy (ET) significantly reduced the risk of disease recurrence compared to standard ET alone in the adjuvant setting1…
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Media ReleaseSandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulationBiosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will…
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Media ReleaseNovartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onsetChildren in LT-001 treated after SMA symptom onset maintained or achieved additional milestones up to 7.5 years post one-time intravenous infusionAll children (100%) in the presymptomatic intravenous…
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Media ReleaseNovartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancerNew approval based on TADPOLE trial showing overall response rate (ORR) of 47% and median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist compared to 11% ORR and 7.4 months…
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Media ReleaseSandoz signs Memorandum of Understanding to build new biologics production plant in Slovenia, to support increasing global demand for biosimilar medicinesSandoz investment expected to be at least USD 400m – MOU signed today in Ljubljana at ceremony led by Slovenian Prime Minister and Sandoz CEO New project underpins Sandoz ambition to drive…
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Media ReleaseNovartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General MeetingShareholders approve 26th consecutive dividend increase to CHF 3.20 (+3.2%) per share for 2022; representing a 4.0% yield1 and approximately 61% payout of free cash flow Shareholders confirm Joerg…
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