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… -
Statement
Novartis provides update on Phase III STAND trial assessing crizanlizumab
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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… -
Pulse Update
Novartis shares strategy insights and highlights key pipeline catalysts at JP Morgan Healthcare Conference 2023
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Statement
Zolgensma Global Managed Access Program in 2023
December 2022
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Compassionate use: Providing access to much needed treatments
What happens when a patient’s only treatment hope rests with a promising but not yet locally approved therapy? At Novartis, we are providing a lifeline of access to innovative medicines under review or not yet approved locally when no other treatment options are available.
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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… -
Key Release
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…
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