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Press release / Oct 21, 2020

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 release / Oct 16, 2020

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 / Sep 11, 2020

Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis

New post hoc data from Phase III ASCLEPIOS trials showed newly diagnosed, treatment-naïve patients experienced reductions in annualized relapse rates and MRI lesion activity and demonstrated…
Press release / Jan 22, 2018

AveXis Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

CHICAGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the closing of its previously announced underwritten public offering of 4,509,840 shares of its common stock…
Press release / Oct 23, 2020

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…
Ad hoc release / Oct 24, 2022

Novartis investigational oral monotherapy iptacopan demonstrates clinically meaningful superiority over anti-C5 treatment in Phase III APPLY-PNH study

Ad hoc announcement pursuant to Art. 53 LRPhase III APPLY-PNH trial met its two primary endpoints for superiority versus anti-C5 treatment in adult paroxysmal nocturnal hemoglobinuria (PNH) patients…
Press release / Aug 29, 2022

Novartis Scemblix®, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukemia

Approval based on results from pivotal Phase III ASCEMBL trial, in which Scemblix® (asciminib) nearly doubled the major molecular response rate vs. Bosulif®* (bosutinib) (25.5% vs. 13.2%) with a more…
Press release / Dec 13, 2022

Novartis presents pivotal Phase III APPLY-PNH data at ASH demonstrating investigational oral monotherapy iptacopan superiority over anti-C5

Trial met both primary and most secondary endpoints, showing iptacopan provided transfusion-free hemoglobin-level increases in vast majority of adult paroxysmal nocturnal hemoglobinuria (PNH)…
Press release / Jan 04, 2022

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…
Press release / May 11, 2023

Novartis to feature new PNH and CML scientific data from broad hematology portfolio at European Hematology Association Annual Meeting

Updated iptacopan data confirm hemolysis control in paroxysmal nocturnal hemoglobinuria (PNH) patients from Phase III APPLY-PNH and APPOINT-PNH studies Head-to-head data from Phase III…