Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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October 2023
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Media ReleaseNovartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane settingPhase 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…
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Media ReleaseNovartis Kisqali® NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancerLate-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,…
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Media ReleaseNovartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancerKey data from the Phase III PSMAfore trial has been selected for a Presidential session; PSMAfore is investigating PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan) in the pre-chemotherapy…
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Key ReleaseNovartis executes Sandoz Spin-off, completing strategic transformation into a leading, focused innovative medicines companyAd hoc announcement pursuant to Art. 53 LR Novartis executes separation of the Sandoz business to create an independent company by way of a 100% Spin-offShares of Sandoz will be listed and…
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Key ReleaseNovartis 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…
September 2023
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Media ReleaseNovartis completes divestment of ‘front of eye’ ophthalmology assetsDivestment includes Xiidra®, on-market treatment for dry eye disease and additional ophthalmic investigational therapiesNovartis advances strategy of focused portfolio and prioritized therapeutic…
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Media ReleaseSandoz receives European Commission approval for Tyruko® (natalizumab), first and only biosimilar for multiple sclerosis in EuropeBiosimilar 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…
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Media ReleaseNovartis 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…
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Media ReleaseNovartis confirms Sandoz Spin-off for October 4, 2023Sandoz shares (SDZ) to be listed and traded on SIX Swiss Exchange; ADRs to be traded on OTCQX®, first trading day October 4, 2023Sandoz to be included in key Swiss market indicesInvestment grade…
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Media ReleaseSandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumabPositive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical dataBreast and gastric cancers are among most common types of cancer, accounting together for nearly half…
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Media ReleaseNovartis shareholders approve the proposed 100% Spin-off of SandozShareholders approve the proposed 100% Spin-off of Sandoz, the Generics and Biosimilars business of NovartisShareholders also approve a reduction of share capital in connection with the Spin-off…
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Media ReleaseNovartis Kisqali® reduced the risk of cancer recurrence while maintaining quality of life in patients diagnosed with early breast cancerPatient-reported outcomes (PROs) from the Phase III NATALEE trial show that patients receiving adjuvant Kisqali plus endocrine therapy (ET) for up to three years maintained physical and social…