Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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October 2020
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Media Release
Novartis received European Medicines Agency (EMA) PRIME designation for iptacopan (LNP) in C3 glomerulopathy (C3G)
The European Medicines Agency has granted iptacopan a priority medicines (PRIME) designation in C3 glomerulopathy (C3G). PRIME is granted for medicines that may offer major therapeutic advance… -
Media Release
New Phase III analysis demonstrates Novartis Beovu® showed improvement in best-corrected visual acuity in wet AMD patients with early persistent fluid
In a post-hoc analysis of HAWK and HARRIER, fewer Beovu (brolucizumab) patients had early persistent fluid (12.5% vs. 20.4% of aflibercept patients), defined as the presence of intra-retinal fluid… -
Media Release
Zolgensma® data including patients with more severe SMA at baseline further demonstrate therapeutic benefit, including prolonged event-free survival, increased motor function and milestone achievement
Nearly two-thirds of patients (65.6%) in STR1VE-EU have already achieved developmental motor milestones not observed in the natural history of SMA Type 1 at a mean duration of follow-up of 10.6…
September 2020
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Key Release
Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program
Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101 intrathecal (IT) formulation in older patients with SMA to further support registration Basel,… -
Media Release
Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale
Kisqali is the only CDK4/6 inhibitor, in combination with endocrine therapy, to achieve a perfect 5 out of 5 score – confirming substantial benefit for premenopausal women with HR+/HER2- advanced… -
Media Release
Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation
In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a… -
Media Release
Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma
Based on unprecedented progression-free survival results, Tafinlar (dabrafenib) + Mekinist (trametinib) confirmed as standard-of-care, targeted therapy for advanced BRAF-mutated melanoma1-4 … -
Media Release
Novartis Tafinlar® + Mekinist® demonstrates long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM
COMBI-AD is first trial to demonstrate 5-year relapse-free survival with targeted therapy as adjuvant treatment in high-risk patients with stage III BRAF-mutated melanoma1 Adjuvant… -
Media Release
Novartis reinforces commitment to patient access, pricing a EUR 1.85 billion sustainability-linked bond
First healthcare industry sustainability-linked bond (SLB) further embeds Environmental Social Governance (ESG) targets into the core of Novartis business operations SLB linked to 2025 Patient Access… -
Media Release
European Medicines Agency (EMA) approves safety label update for Novartis Beovu®
Novartis worked with the EMA to update the Beovu® (brolucizumab) label to guide physicians in their treatment of wet AMD The update includes the additional characterization of retinal… -
Media Release
Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME)
In Phase III KITE study, Beovu (brolucizumab) 6 mg achieved its primary endpoint of non-inferiority to aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52)1… -
Media Release
Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS)
Post hoc EXPAND analysis showed improvements in cognitive processing speed in patients with active and non-active SPMS treated with Mayzent1 Subgroup analyses of the EXPAND trial showed the…