Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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April 2022
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Press Release
Novartis announces anti-PD-1 tislelizumab accepted by EMA for regulatory review in esophageal and lung cancers
European Medicines Agency validated MAAs for tislelizumab in multiple non-small cell lung cancer and esophageal squamous cell carcinoma indicationsSubmissions based on data from Phase III RATIONALE… -
Press Release
Sandoz extends collaboration agreement to drive cutting-edge digital solutions in global fight against antimicrobial resistance (AMR)
Extending existing master services agreement with Ares Genetics, to develop digital platform for development and life cycle management of antibiotics, to January 31, 2025Both parties strengthening… -
Press Release
FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)
Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is… -
Press Release
Novartis presents new four-year data on efficacy and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis
Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension demonstrated the efficacy and safety of continuous Kesimpta® (ofatumumab) treatment and in those switched from teriflunomide, with… -
Press Release
Novartis expands Zolgensma manufacturing capacity with approval of multi-product North Carolina facility
Clearance of critical milestone expands capability for production of gene therapies, starting with Zolgensma® Basel, April 5, 2022 – Novartis today announced the U.S. Food and Drug Administration (… -
Ad-hoc Release
Novartis announces new organizational structure to accelerate growth, strengthen pipeline and increase productivity
Ad hoc announcement pursuant to Art. 53 LRNew simplified structure and operational set-up supports Novartis strategy as a focused medicines company and is designed to power next phase of… -
Ad-hoc Release
Novartis gibt neue Organisationsstruktur bekannt für schnelleres Wachstum, eine stärkere Pipeline und höhere Produktivität
Ad-hoc-Mitteilung gemäss Art. 53 KRDie neue, vereinfachte Struktur und Organisation werden die Strategie von Novartis als fokussiertes Arzneimittelunternehmen unterstützen und die nächste Phase…
March 2022
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Press Release
Novartis announces European Commission approval of Beovu® for people living with diabetic macular edema
Diabetic macular edema (DME) is a leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution in the retina and addressing the burden of… -
Press Release
Novartis receives positive CHMP opinion for Jakavi® to treat acute and chronic graft-versus-host disease
CHMP opinion based on Phase III REACH2 and REACH3 trials that showed Jakavi improved response rates and failure-free survival compared to best available therapy1,2 Graft-versus-host disease (GvHD)… -
Press Release
Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe
Positive opinion paves way for third indication in Europe for Kymriah, a potentially definitive single infusion CAR-T cell therapy treatment optionCHMP opinion based on Phase II global ELARA trial… -
Ad-hoc Release
Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer
Ad hoc announcement pursuant to Art. 53 LR FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive… -
Press Release
New peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta® (ofatumumab)-treated adults with multiple sclerosis
The study published in ‘Neurology and Therapy’ also shows the fatal outcomes and hospitalization rates due to COVID-19 in those treated with Kesimpta were in line with the rates in the general MS…