Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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December 2021
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Key Release
FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year
Ad hoc announcement pursuant to Art. 53 LR With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol… -
Media Release
Novartis to acquire Gyroscope Therapeutics, adding a one-time gene therapy that could transform care for geographic atrophy, a leading cause of blindness
There are no currently approved therapies impacting disease progression for the up to 8 million people suffering from geographic atrophy (GA)1,2 Acquisition will add GT005 to the Novartis portfolio… -
Media Release
Sandoz submits Marketing Authorization Application for proposed biosimilar trastuzumab to EMA
Submission is supported by comprehensive package of analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc.Breast cancer is one of most common types of… -
Media Release
Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biologics License Application (BLA) is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc. Trastuzumab is monoclonal… -
Media Release
Novartis strengthens immunotherapy pipeline with option, collaboration and license agreement with BeiGene for TIGIT inhibitor ociperlimab
Ociperlimab adds innovative and complementary late-stage TIGIT inhibitor to an Oncology portfolio poised for growth Two Phase III trials underway in non-small cell lung cancer and additional studies… -
Key Release
Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU)
Ad hoc announcement pursuant to Art. 53 LR Ligelizumab, a high-affinity anti-IgE antibody, demonstrated superiority compared with placebo at Week 12 in Phase III PEARL 1 and… -
Key Release
Novartis initiates new USD 15 billion share buyback highlighting confidence in growth and pipeline
Ad hoc announcement pursuant to Art. 53 LR Share buyback of up to USD 15bn planned to be executed by end 2023, highlighting confidence in top line growth and deep pipelineSales expected to grow… -
Media Release
Novartis announces T-Charge™, next-generation CAR-T platform with first-in-human data at ASH 2021
T-Charge, a next-generation platform that aims to revolutionize CAR-T cell therapy, will serve as foundation for various investigational CAR-T therapies Early data from first-in-human dose-… -
Media Release
Novartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with chronic myeloid leukemia
Updated 48-week data from Phase III ASCEMBL trial consistent with improved major molecular response (MMR) rate of Scemblix® (asciminib) vs. Bosulif®* (bosutinib) and lower discontinuation rate due to… -
Media Release
Novartis Kymriah® demonstrates strong responses in high-risk patients with relapsed or refractory follicular lymphoma in extended study follow-up
Complete and overall response rates and durability of response were well maintained across majority of high-risk subgroups with a significant unmet need1 Median follow-up of approximately 17 months… -
Media Release
Novartis data highlight efficacy of Piqray® in HR+/HER2- metastatic breast cancer with a PIK3CA driver mutation immediately post-CDK4/6i
New data underscore efficacy of Piqray, even in those patients with a short treatment duration on prior CDK4/6i or with ESR1 mutations, biomarkers of endocrine resistance1-5 Recent guideline… -
Media Release
Novartis announces positive results from year two of the Phase III trial of Beovu® in diabetic macular edema
Results from year two of the Phase III KESTREL clinical trial confirmed year one findings, with an overall favorable benefit-risk profile for Beovu® (brolucizumab) 6 mg in patients with visual…