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Press release / Mar 19, 2025

New Novartis Phase III data demonstrate meaningful efficacy and safety results of intrathecal onasemnogene abeparvovec in broad patient population with SMA

Treatment with investigational OAV101 IT led to statistically significant 2.39-point improvement on the HFMSE vs. 0.51 points in sham control armSafety findings were consistent in both treatment-…
Press release / Nov 12, 2025

Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance

Phase III trial for KLU156 (ganaplacide/lumefantrine, or GanLum), meets primary endpoint of non-inferiority to standard of care Coartem® (artemether-lumefantrine) Demonstrates PCR-corrected cure rate…
Press release / Dec 12, 2016

Novartis provides update on pegpleranib Phase III clinical trial program in patients with neovascular age-related macular degeneration (nAMD or wet AMD)

Two pivotal Phase III studies did not show additional improvement in best corrected visual acuity (BCVA) for pegpleranib and Lucentis (ranibizumab) combination treatment over standard of care…
Press release / Dec 22, 2017

Novartis' combination therapy Tafinlar® + Mekinist® granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma

Priority Review designation based on Phase III study showing 53% reduction in risk of recurrence or death with Tafinlar + Mekinist, as compared to placebo[1] Improvements observed in key…
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 / Jun 04, 2021

Novartis investigational checkpoint inhibitor tislelizumab met primary endpoint of overall survival in pivotal Phase III trial of esophageal cancer after systemic therapy

Tislelizumab demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared to chemotherapy in advanced or metastatic esophageal squamous cell carcinoma…
Press release / Sep 16, 2020

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…
Press release / Sep 14, 2020

Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME)

In Phase III KITE study, Beovu (brolucizumab) 6 mg achieved its primary endpoint of non-inferiority to aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52)1…
Press release / Oct 05, 2020

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 / Sep 11, 2017

Novartis Phase III study demonstrates adjuvant Tafinlar® + Mekinist® reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma

The three-year relapse-free survival (RFS) rate for patients treated with the combination was 58%, compared to 39% with placebo[1] Consistent improvement in RFS observed across all pre-specified…

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