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Press release / Dec 06, 2024

New Phase IIIB data shows Novartis Fabhalta® improved hemoglobin levels in adult patients with paroxysmal nocturnal hemoglobinuria who switched from anti-C5 therapy

In the Phase IIIB APPULSE-PNH study, oral Fabhalta® (iptacopan) improved the average hemoglobin (Hb) level versus baseline in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were…
Press release / May 05, 2019

AveXis presented robust data at AAN demonstrating efficacy of Zolgensma® in broad spectrum of spinal muscular atrophy (SMA) patients

Interim data reported for the first time from STRONG in SMA Type 2 showed rapid motor function gains and milestone achievements with intrathecal Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101…
Press release / Oct 08, 2018

Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients

There is a critical need for safe and effective treatments for secondary progressive multiple sclerosis (SPMS) - a highly debilitating form of MS characterized by gradual, irreversible worsening of…
Press release / Oct 20, 2018

Novartis investigational BYL719 (alpelisib) plus fulvestrant nearly doubles median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer compared to fulvestrant alone

In SOLAR-1 trial, BYL719 plus fulvestrant significantly improved PFS and ORR in these patients, following progression on or after an aromatase inhibitor with or without a CDK4/6 inhibitor, vs.…
Press release / Apr 23, 2021

Novartis to initiate SMART Phase 3b global study of Zolgensma in children up to 21 kg, building on real-world experience

SMART study to extend data beyond patient population studied in clinical trials New clinical study to evaluate safety and efficacy of Zolgensma in children up to 21 kg, adding to real-world…
Press release / Jun 03, 2019

Xolair® (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies

In the phase III POLYP 1 and POLYP 2 studies, omalizumab met both co-primary endpoints and key secondary endpoints in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) with inadequate…
Press release / Oct 26, 2020

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,…
Ad hoc release / Aug 03, 2021

Novartis announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients with SMA

Ad hoc announcement pursuant to Art. 53 LR FDA concluded that OAV-101 intrathecal (IT) clinical program may proceed based on data from nonclinical toxicology study New Phase 3 STEER study will…
Press release / Apr 29, 2020

Novartis Cosentyx® gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum

Cosentyx® is the first fully-human IL-17A inhibitor indicated for patients in Europe with non-radiographic axial spondyloarthritis (nr-axSpA), which forms part of the axial spondyloarthritis (axSpA)…
Press release / Jun 03, 2022

New Novartis data show Piqray® effectiveness across key biomarkers in patients with HR+/HER2- metastatic breast cancer

Biomarker analysis from Phase III SOLAR-1 study shows Piqray plus fulvestrant had clinical benefit regardless of presence of ESR1 mutations and genes implicated in CDK4/6i resistance1 Piqray plus…