Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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January 2023
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Press Release
Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilar
Sandoz is seeking approval of high concentration formulation (HCF) adalimumab for use in all indications of reference medicine Upon approval, HCF formulation will offer patients enhanced yet familiar… -
Press Release
Sandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolio
Sandoz plans to acquire worldwide product rights for Mycamine® (micafungin sodium) from AstellasAcquiring leading global echinocandin, one of three major antifungal classes, will significantly…
December 2022
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Press Release
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
Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer
EC approval based on results from pivotal Phase III VISION trial, in which Pluvicto® plus best standard of care (BSoC) significantly improved overall survival and radiographic progression-free… -
Press Release
Novartis investigational iptacopan provides clinically meaningful increases in hemoglobin levels in complement-inhibitor-naïve patients with PNH
Phase III APPOINT-PNH study of investigational oral monotherapy iptacopan met its primary endpoint; second positive Phase III topline readout for iptacopan in paroxysmal nocturnal hemoglobinuria (PNH… -
Press Release
Novartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer compared to chemotherapy
RIGHT Choice Phase II trial is the first randomized study in patients with aggressive HR+/HER2− metastatic breast cancer (MBC), including visceral crisis, comparing a CDK4/6 inhibitor (CDK4/6i) plus… -
Ad-hoc Releases
Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer
Ad hoc announcement pursuant to Art. 53 LR Phase III PSMAfore trial with PluvictoTM met the primary endpoint of radiographic progression-free survival (rPFS) in PSMA–positive mCRPC who have been…
November 2022
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Press Release
Novartis and Medicines for Malaria Venture announce decision to move to Phase 3 study for novel ganaplacide/lumefantrine-SDF combination in adults and children with malaria
Novartis and Medicines for Malaria Venture (MMV) announce decision to move to Phase 3 study for novel non-artemisinin combination to treat uncomplicated malariaThis novel combination also contains an… -
Press Release
Novartis highlights scientific advances with Kisqali, iptacopan, Scemblix and YTB323 data at SABCS and ASH
First data to be presented as a late-breaker abstract from global pivotal APPLY-PNH trial of investigational oral monotherapy iptacopan in paroxysmal nocturnal hemoglobinaria (PNH), a rare and… -
Press Release
New long-term Leqvio® (inclisiran) data from Novartis show sustained efficacy and safety over four years
Results from ORION-3 open-label trial show twice-yearly* Leqvio®(inclisiran), as a complement to statin therapy, provides effective and sustained reductions in low-density lipoprotein cholesterol (… -
Press Release
Sandoz announces further investment in key manufacturing facility in Austria, to support increased global demand for essential antibiotics
EUR 50m planned investment to support increased manufacturing capacity for finished dosage form penicillins, the leading class of antibiotics worldwideNew project brings total planned investment into…