Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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December 2020
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Key Release
Novartis receives complete response letter from U.S. FDA for inclisiran
The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related… -
Press Release
Novartis builds on commitment to addressing need in neuropsychiatric disorders with Cadent Therapeutics acquisition
The agreement includes two clinical stage molecules for schizophrenia and movement disorders and MIJ821, a clinical stage molecule previously licensed exclusively by Novartis for addressing treatment… -
Press Release
Novartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, resulting in debilitating symptoms that can impact patients’ quality of life1–3C3 glomerulopathy (C3G) is a… -
Press Release
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)Potential Q1 2021 sNDA approval… -
Press Release
Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema
In Phase III KESTREL study, Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)1In a… -
Featured News
The RUXCOVID clinical trial
The RUXCOVID clinical trial highlights the Novartis commitment to leverage our expertise and resources to support the global response to the COVID-19 pandemic.
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Press Release
Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)1 Detailed… -
Press Release
Novartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year**
Leqvio® (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe1-3 Cardiovascular disease causes 3.9… -
Press Release
Novartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer
Findings presented at SABCS from largest intrinsic subtype analysis show Kisqali is unique among CDK4/6 inhibitors, delivers consistent efficacy across main HR+/HER2- intrinsic subtypes1Benefit seen… -
Press Release
Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer
MONALEESA-7 median overall survival (OS) results reinforce Kisqali as the CDK4/6 inhibitor with unrivaled OS evidence1Kisqali plus endocrine therapy had a median OS of nearly five years (58.7… -
Press Release
Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial
At 24 weeks, asciminib nearly doubled the major molecular response (MMR) rate compared to Bosulif® (bosutinib)*, in patients resistant to, or intolerant of, at least two prior tyrosine kinase…