Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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November 2023
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Key ReleaseNovartis upgrades mid-term sales growth guidance, showcases its differentiated innovative medicines strategy and robust pipeline at R&D DayAd hoc announcement pursuant to Art. 53 LR ‘Pure-play’ innovative medicines strategy focused on four therapeutic areas and five technology platforms, which offer potential for consistent…
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Media ReleaseNovartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASHLate-breaking final iDFS analysis from NATALEE investigating Kisqali® (ribociclib) in broad population of patients with stage II and III HR+/HER2- early breast cancer, including those with node-…
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Media ReleaseNovartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2In pivotal Phase III trials, remibrutinib – a highly selective, oral Bruton’s tyrosine kinase inhibitor – demonstrated clinically meaningful and statistically significant reduction in urticaria…
October 2023
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Media ReleaseFDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decadeFDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21As the only IL-17A inhibitor…
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Key ReleaseNovartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)Ad hoc announcement pursuant to Art. 53 LR Phase III ALIGN study met its primary endpoint, demonstrating superiority of atrasentan vs. placebo in proteinuria reduction at 36-week interim analysis1;…
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Media ReleaseNovartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centersUS FDA has classified drug shortage status as resolved1Novartis capacity to produce Pluvicto will continue to grow with anticipated expansions to the manufacturing network in the US and globally More…
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Key ReleaseNovartis delivers 12% sales and 21% core operating income growth from continuing operations (in cc¹). Executes Sandoz spin-off, achieves important innovation milestones, and raises FY 2023 guidanceAd hoc announcement pursuant to Art. 53 LR Transformation into a “pure-play” innovative medicines business is complete, with the spin-off of Sandoz; commentary below is on continuing…
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Media ReleaseNovartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane settingPhase III PSMAfore trial with Pluvicto™ met its primary endpoint of radiographic progression-free survival (rPFS) with a HR of 0.411; Pluvicto more than doubled median rPFS to 12.0 months per updated…
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Media ReleaseNovartis Kisqali® NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancerLate-breaking NATALEE subgroup analysis to be presented at ESMO shows invasive disease-free survival (iDFS) benefit remains consistent in all subgroups, including in patients with stage II tumors,…
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Media ReleaseNovartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancerKey data from the Phase III PSMAfore trial has been selected for a Presidential session; PSMAfore is investigating PluvictoTM(INN: lutetium (177Lu) vipivotide tetraxetan) in the pre-chemotherapy…
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Key ReleaseNovartis executes Sandoz Spin-off, completing strategic transformation into a leading, focused innovative medicines companyAd hoc announcement pursuant to Art. 53 LR Novartis executes separation of the Sandoz business to create an independent company by way of a 100% Spin-offShares of Sandoz will be listed and commence…
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Key ReleaseNovartis investigational iptacopan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)Ad hoc announcement pursuant to Art. 53 LR Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria…