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Ad hoc release / Oct 02, 2023

Novartis investigational iptacopan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)

Ad hoc announcement pursuant to Art. 53 LR Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria…
Press release / Sep 25, 2023

Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Phase III NETTER-2 trial met primary endpoint of improvement in progression-free survival (PFS) and key secondary endpoint of objective response rate (ORR) in patients with Grade 2 and 3 advanced…
Press release / Sep 26, 2023

Sandoz receives European Commission approval for Tyruko® (natalizumab), first and only biosimilar for multiple sclerosis in Europe

Biosimilar Tyruko® approved for all indications of reference medicine, as first and only biosimilar to treat relapsing forms of multiple sclerosis (MS) in EuropeDecision based on evidence from…
Press release / Nov 09, 2023

Novartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2

In pivotal Phase III trials, remibrutinib – a highly selective, oral Bruton’s tyrosine kinase inhibitor – demonstrated clinically meaningful and statistically significant reduction in urticaria…
Press release / Oct 23, 2023

Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting

Phase III PSMAfore trial with Pluvicto™ met its primary endpoint of radiographic progression-free survival (rPFS) with a HR of 0.411; Pluvicto more than doubled median rPFS to 12.0 months per updated…
Ad hoc release / Oct 24, 2023

Novartis delivers 12% sales and 21% core operating income growth from continuing operations (in cc¹). Executes Sandoz spin-off, achieves important innovation milestones, and raises FY 2023 guidance

Ad hoc announcement pursuant to Art. 53 LR Transformation into a “pure-play” innovative medicines business is complete, with the spin-off of Sandoz; commentary below is on continuing…
Ad hoc release / Oct 24, 2023

Novartis : hausse de 12% du chiffre d’affaires et de 21% du résultat opérationnel core (tcc¹). Spin-off de Sandoz, étapes importantes de l’innovation ; hausse des prévisions pour 2023

Annonce événementielle au sens de l’art. 53 RC Le spin-off de Sandoz parachève la spécialisation d’Innovative Medicines dans les médicaments innovants le commentaire ci-dessous concerne les…
Press release / Oct 26, 2023

Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers

US FDA has classified drug shortage status as resolved1 Novartis capacity to produce Pluvicto will continue to grow with anticipated expansions to the manufacturing network in the US and globally…
Press release / Oct 20, 2023

Novartis Kisqali® NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer

Late-breaking NATALEE subgroup analysis to be presented at ESMO shows invasive disease-free survival (iDFS) benefit remains consistent in all subgroups, including in patients with stage II tumors,…
Press release / Oct 31, 2023

FDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade

FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21 As the only IL-17A inhibitor…