Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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March 2024
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Media ReleaseNovartis Fabhalta® (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH)Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior hemoglobin improvement in the absence of transfusions with Fabhalta compared to anti-C5 therapy1-5 If…
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Media ReleaseNovartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General MeetingShareholders approve 27th consecutive dividend increase to CHF 3.30 (+3.1%) per share for 2023; representing a 3.7% yield1 and approximately 58% payout of free cash flowShareholders confirm Joerg…
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Media ReleaseNovartis presents new data on safety and efficacy of Zolgensma, including maintained and improved motor milestones in older and heavier children with SMAThe SMART study supplements a growing body of evidence on the use of Zolgensma in a patient population older and heavier (1.5 – 9.1 years of age) than the children treated in previous clinical…
January 2024
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Key ReleaseNovartis delivers strong full year performance, 10% net sales and 18% core operating income growth (cc¹), with margin expansion. Continuing innovation momentum with multiple positive Ph3 readoutsAd hoc announcement pursuant to Art. 53 LRFull year (continuing operations2)Net sales grew +10% (cc, +8% USD) with core operating income growing +18% (cc, +11% USD)Sales growth was mainly driven by…
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Media ReleaseNovartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumorsIn the Phase III NETTER-2 trial, Lutathera plus octreotide LAR significantly extended median PFS to 22.8 months vs. 8.5 months with high-dose octreotide LAR in patients with newly diagnosed grade 2…
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Key ReleaseNovartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemiaMEDIA & INVESTOR RELEASE Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard-of-care TKIs in Phase III trial for newly diagnosed patients with chronic…
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Media ReleaseNovartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in IndianapolisFDA approval of the company’s second US Radioligand Therapy (RLT) manufacturing facility increases RLT production capacity to 250,000 doses in 2024 and beyondNew 70,000-square foot RLT facility is…
December 2023
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Key ReleaseNovartis investigational iptacopan Phase III study demonstrates clinically meaningful and statistically significant proteinuria reduction in patients with C3 glomerulopathy (C3G)Ad hoc announcement pursuant to Art. 53 LR Phase III APPEAR-C3G study met its primary endpoint, demonstrating superiority of iptacopan vs. placebo in proteinuria reduction at six-month analysis1;…
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Media ReleaseNovartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)APPLY-PNH extension data show that continuous Fabhalta® (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled sustained hemoglobin-level increases to near-…
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Media ReleaseLatest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissionsWith 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows sustained iDFS benefit and stability in…
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Key ReleaseNovartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNHAd hoc announcement pursuant to Art. 53 LR Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement…
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