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Ad hoc release / Mar 27, 2023

Novartis Kisqali® Phase III NATALEE trial meets primary endpoint at interim analysis demonstrating clinically meaningful benefit in broad population of patients with early breast cancer

Ad hoc announcement pursuant to Art. 53 LR Kisqali plus endocrine therapy (ET) significantly reduced the risk of disease recurrence compared to standard ET alone in the adjuvant setting1…
Press release / Feb 27, 2018

AveXis Reports Fourth Quarter and Full Year 2017 Financial and Operating Results

– On track to request pre-BLA meeting with FDA in Q2 2018 – – Intends to initiate pivotal trial in SMA Type 1 in Europe and multi-national pre-symptomatic SMA study in the first half of…
Press release / Oct 17, 2025

Novartis Kisqali® 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population

After 5 years, Kisqali® plus endocrine therapy consistently shows significant and clinically meaningful benefit in invasive disease-free survival1 Kisqali remains the only CDK4/6 inhibitor…
Press release / May 25, 2024

Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (…
Press release / Jun 01, 2025

Novartis Kisqali® reduces risk of recurrence in younger patients with early breast cancer in NATALEE subgroup analysis

33% reduction in relative risk of invasive disease observed in pre-menopausal early breast cancer (EBC) patients receiving Kisqali in 1-year post-treatment analysis1Tolerability remained consistent,…
EU Standard Contractual Clauses (Controller to Controller)
Press release / Sep 14, 2023

Novartis Kisqali® reduced the risk of cancer recurrence while maintaining quality of life in patients diagnosed with early breast cancer

Patient-reported outcomes (PROs) from the Phase III NATALEE trial show that patients receiving adjuvant Kisqali plus endocrine therapy (ET) for up to three years maintained physical and social…
Press release / Apr 26, 2023

Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients

Data at EBMT show primary endpoint met – estimated* 92.2% of complement-inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH) achieving 2 g/dL or more hemoglobin-level increase…
Press release / Dec 11, 2023

Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)

APPLY-PNH extension data show that continuous Fabhalta® (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled sustained hemoglobin-level increases to near-…
Press release / Nov 27, 2024

Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence

Approval is based on Phase III NATALEE data showing Kisqali® (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit in…