Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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May 2023
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Media ReleaseSandoz Marketing Authorization Applications for proposed biosimilar denosumab accepted by EMASubmissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trialDenosumab is indicated for…
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Media ReleaseNew Sandoz Board of Directors appointedNovartis Board of Directors approves the recommendation of Sandoz Chairman-designate for the future Sandoz Board of Directors, to start preparatory work in June, followed by formal constitution in H2…
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Media ReleaseNovartis to feature new PNH and CML scientific data from broad hematology portfolio at European Hematology Association Annual MeetingUpdated iptacopan data confirm hemolysis control in paroxysmal nocturnal hemoglobinuria (PNH) patients from Phase III APPLY-PNH and APPOINT-PNH studies Head-to-head data from Phase III…
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Media ReleaseSandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilarsSandoz and Just - Evotec Biologics announce partnership to develop and manufacture multiple biosimilars with an option for expansion Sandoz gains access to proprietary AI-driven technology platform…
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Media ReleaseSandoz to exclusively commercialize six products in the US, reinforcing global leadership position in off-patent medicinesAgreement offers exclusive rights to commercialize six products in key areas of anti-infectives and oncology. Products from Adalvo slated for near- to mid-term launches, with four out of six…
April 2023
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Media ReleaseNovartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativaPositive opinion paves way for first new treatment option in hidradenitis suppurativa (HS) in nearly a decade Committee for Medicinal Products for Human Use (CHMP) opinion based on robust Phase…
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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…
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