Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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January 2022
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Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19
Topline results from the randomized EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo,… -
Novartis announces collaboration with Alnylam to explore targeted therapy to restore liver function
Agreement will bring Alnylam’s proprietary siRNA technology to bear on liver target identified by Novartis researchers Novartis and Alnylam have agreed to collaborate on discovery and development of… -
Novartis announces U.S. Court of Appeals for the Federal Circuit (CAFC) upholds validity of Gilenya® (fingolimod) dosage regimen patent
Basel, January 4, 2022 — Today, Novartis announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No. 9,187,405 covering a…
December 2021
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Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis
New approvals are based on JUNIPERA trial data showing Cosentyx® (secukinumab) demonstrated reduced flare risk versus placebo and improvement in disease activity observed over two years across both… -
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… -
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… -
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… -
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… -
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… -
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… -
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…
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