Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
Header
News Archive
Showing 1236 results
October 2020
-
Press Release
Novartis presents promising interim Phase II data of potential first-in-class oral therapy iptacopan (LNP023) in rare renal disease C3 glomerulopathy (C3G)
C3 glomerulopathy (C3G) is a rare renal disease, affecting young patients with a poor prognosis and significant unmet need.1–3 Iptacopan (LNP023) is a potential first-in-class, oral,… -
Press Release
Novartis announces European Medicines Agency (EMA) has granted orphan drug designation for iptacopan (LNP023) in IgA nephropathy (IgAN)
Orphan drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases IgA nephropathy (IgAN), while rare, is the most common form of… -
Press Release
Novartis receives US Food and Drug Administration (FDA) Orphan Drug Designation for branaplam (LMI070) in Huntington’s disease (HD)
Huntington’s disease is a rare, inherited neurodegenerative disease that leads to progressive disability and deathThere are no approved disease modifying therapies that delay disease onset or slow… -
Ad-hoc Releases
Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol
If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients with hypercholesterolemia or mixed dyslipidemia1Cardiovascular disease (CVD) claims 3.9… -
Press 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… -
Press 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… -
Press 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
-
Ad-hoc Releases
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,… -
Press 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… -
Press 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… -
Press 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 … -
Press 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…