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Novartis AG (NOVN.SW)

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As of 3:32 PM GMT+2. Market Open.

Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria

There is currently no evidence-based treatment for the smallest babies with malaria The CALINA study tested a new ratio and dose of Coartem® (artemether- lumefantrine) to account for metabolic differences in babies under 5 kg The CALINA trial indicated that the new formulation has good efficacy and safety, and the data have been submitted for regulatory review Basel, April 24, 2024 – Novartis and Medicines for Malaria Venture (MMV) announce positive data from their phase II/III CALINA study, dem

GlobeNewswire 5 days ago
Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Approval based on NETTER-P trial in which Lutathera demonstrated a consistent safety profile and comparable drug exposure between pediatric (ages 12-17) and adult patients Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a rare cancer that is often unresectable and commonly diagnosed in the late stages of diseaseNovartis, a leader in radioligand therapy (RLT), is investigating a portfolio of RLTs to treat a broad range of cancers, including GEP-NETs, lung, prostate, breast, colon, bra

GlobeNewswire 5 days ago
Novartis delivers double-digit sales growth and core margin expansion in Q1; FY 2024 guidance raised

Ad hoc announcement pursuant to Art. 53 LRQ1 net sales grew +11% (cc1, +10% USD) with core operating income up +22% (cc, +16% USD) Key growth drivers continued strong sales momentum including Entresto (+36% cc), Cosentyx (+25% cc), Kesimpta (+66% cc), Kisqali (+54% cc), Pluvicto (+47% cc) and Leqvio (+139% cc)Core operating income margin 38.4%, +340 basis points (cc), mainly driven by higher net salesOperating income grew +39% (cc, +29% USD) and net income grew +37% (cc, +25% USD), mainly driven

GlobeNewswire 6 days ago
Novartis Kesimpta® six-year efficacy data show substantial benefits in recently diagnosed treatment- naïve people with relapsing multiple sclerosis

Continuous Kesimpta® treatment for up to six years showed sustained efficacy in recently diagnosed (≤3 years) treatment-naïve people living with relapsing multiple sclerosis (RMS) in an analysis of the ALITHIOS open-label extension study1Similar efficacy outcomes were demonstrated in a separate analysis of continuous Kesimpta treatment for up to six years in the overall ALITHIOS study population2 Switch from teriflunomide to Kesimpta resulted in significant improvements across several efficacy o

GlobeNewswire 12 days ago
New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN)

APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN1IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide2; complement activation is a key driver of glomerular inflammation in IgAN3,4There is a need for effective, targeted therapies for IgAN2,5; up to 30% of patients with persistent proteinuria (≥1 g/day) may progress to kidney failure

GlobeNewswire 13 days ago
Arvinas Enters into a Transaction with Novartis, including a Global License Agreement for the Development and Commercialization of PROTAC® Androgen Receptor (AR) Protein Degrader ARV-766 for the Treatment of Prostate Cancer

– Arvinas to receive a $150 million upfront payment for the license of ARV-766 and the sale of Arvinas’ preclinical AR-V7 program, with the potential under the License Agreement for up to $1.01 billion in development, regulatory, and commercial milestones, as well as tiered royalties – – Novartis to be responsible for worldwide clinical development and commercialization of ARV-766 – – Partnership expected to accelerate and broaden the development of ARV-766 as a potential first-in-class treatmen

GlobeNewswire 18 days ago
Novartis tender offer for MorphoSys AG commences

Basel, April 11, 2024 – Novartis published today the offer document for the voluntary public takeover offer by its wholly owned subsidiary Novartis BidCo AG for all outstanding shares of MorphoSys AG (“MorphoSys”), including all shares represented by MorphoSys American Depositary Shares (the “Offer”), for an offer price of EUR 68.00 per share in cash. The offer price corresponds to a premium of 142% on the volume-weighted average price during the last three months, as of the unaffected January 2

GlobeNewswire 18 days ago
New Novartis data show early addition of twice-yearly* Leqvio® (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting

V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1Results from usual care arm reinforce

GlobeNewswire 22 days ago
Novartis Fabhalta® (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior hemoglobin improvement in the absence of transfusions with Fabhalta compared to anti-C5 therapy1-5 If approved, Fabhalta® will be the first oral monotherapy available in Europe for the treatment of PNH, a chronic and rare blood disorder, in both complement inhibitor-treated and -naive PNH patients with hemolytic anemia1Despite anti-C5 therapy, a large proportion of patients remain anemic, fatigued a

GlobeNewswire last month
Novartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General Meeting

Shareholders approve 27th consecutive dividend increase to CHF 3.30 (+3.1%) per share for 2023; representing a 3.7% yield1 and approximately 58% payout of free cash flowShareholders confirm Joerg Reinhardt as Chair of the Board of Directors as well as all other current members Shareholders approve all other proposals of the Board of Directors, including the reduction of share capital, the 2023 report on non-financial matters (for the first time submitted to shareholders under new Swiss law) and

GlobeNewswire last month
Novartis presents new data on safety and efficacy of Zolgensma, including maintained and improved motor milestones in older and heavier children with SMA

The SMART study supplements a growing body of evidence on the use of Zolgensma in a patient population older and heavier (1.5 – 9.1 years of age) than the children treated in previous clinical studies 1-6 Nearly all patients treated maintained or improved motor milestones after 52 weeks, with most switching to the one-time gene therapy from another chronically administered disease-modifying therapy 1-6The SMART study is the first open-label clinical study of Zolgensma to include previously treat

GlobeNewswire last month
Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor in multiple RAS/MAPK pathway-driven tumors Initial SEACRAFT-1 Phase 1b combination data in RAS Q61X solid tumors expected between Q2-Q4 2024 Initiation of pivotal SEACRAFT-2 in NRASm melanoma expected in H1 2024 SAN DIEGO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients wi

GlobeNewswire 2 months ago
Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys AG for EUR 68 per share or an aggregate of EUR 2.7bn in cash

Transaction to include pelabresib, a late-stage BET inhibitor for myelofibrosis (MF) and tulmimetostat, an early-stage investigational dual inhibitor of EZH2 and EZH1 for solid tumors or lymphomasPelabresib recently met its primary endpoint of spleen volume reduction and demonstrated favorable trends in symptom improvement with a well-tolerated safety profile in Phase 3 MANIFEST-2 study, when administered in combination with ruxolitinib in JAK inhibitor-naive MF patients1 Pelabresib and ruxoliti

GlobeNewswire 2 months ago
Novartis delivers strong full year performance, 10% net sales and 18% core operating income growth (cc¹), with margin expansion. Continuing innovation momentum with multiple positive Ph3 readouts

Ad hoc announcement pursuant to Art. 53 LRFull year (continuing operations2)Net sales grew +10% (cc, +8% USD) with core operating income growing +18% (cc, +11% USD)Sales growth was mainly driven by continued strong performance from Entresto (+31% cc), Kesimpta (+99% cc), Kisqali (+75% cc), Pluvicto (+261% cc) and Scemblix (+179% cc)Operating income increased +39% (cc, +23% USD). Net income increased +62% (cc, +42% USD). Free cash flow from continuing operations was USD 13.2 billion (+9% USD)EPS

GlobeNewswire 2 months ago
Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors

In the Phase III NETTER-2 trial, Lutathera plus octreotide LAR significantly extended median PFS to 22.8 months vs. 8.5 months with high-dose octreotide LAR in patients with newly diagnosed grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)1 NETTER-2 is the first and only positive Phase III trial for a radioligand therapy (RLT) in the first-line setting, demonstrating the potential of RLTs in earlier lines Novartis, a leader in radioligand therapy, is investigating a

GlobeNewswire 3 months ago
Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemia

MEDIA & INVESTOR RELEASE Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard-of-care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemia Ad hoc announcement pursuant to Art. 53 ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results; Scemblix® (asciminib) shows superior MMR rates at week 48 vs. standard-of-care TKIs (imatinib, nilotinib, dasatinib, and bosutinib) in newly diagnosed

GlobeNewswire 3 months ago
Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis

FDA approval of the company’s second US Radioligand Therapy (RLT) manufacturing facility increases RLT production capacity to 250,000 doses in 2024 and beyondNew 70,000-square foot RLT facility is the company’s largest and most advanced in the world to date and centrally located in the US to maximize access for patients and treatment centersWith four active RLT manufacturing sites and unconstrained supply, Novartis can sufficiently meet current and future demand as ongoing clinical trials may pr

GlobeNewswire 3 months ago
Novartis investigational iptacopan Phase III study demonstrates clinically meaningful and statistically significant proteinuria reduction in patients with C3 glomerulopathy (C3G)

Ad hoc announcement pursuant to Art. 53 LR Phase III APPEAR-C3G study met its primary endpoint, demonstrating superiority of iptacopan vs. placebo in proteinuria reduction at six-month analysis1; the safety profile of iptacopan was consistent with previously reported data1-3 C3 glomerulopathy (C3G) is an ultra-rare complement-mediated kidney disease, with approximately 50% of patients progressing to kidney failure within 10 years of diagnosis4-7; currently no treatments address the underlying ca

GlobeNewswire 4 months ago
Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)

Novartis today announced results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) who had residual anemia (hemoglobin <10 g/dL) despite previous anti-C5 therapy1,2. Continuous Fabhalta treatment (200 mg twice daily) for 48 weeks enabled sustained hemoglobin-level increases to near-normal (12 g/dL or more), blood transfusion avoidance, and reduced patient-reported fatigue in the ma

PR Newswire 4 months ago
Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

With 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows sustained iDFS benefit and stability in secondary endpoints including overall survival (OS)1,2 iDFS benefit remains consistent across key patient subgroups; among patients with stage II and stage III tumors, Kisqali lowered risk by 30% and 24.5%, respectively1,2 Latest analysis continues to show a well-tolerated safety profile in line with pre

GlobeNewswire 4 months ago

Performance Overview

Return	NOVN.SW	MSCI WORLD
YTD	+9.18%	+5.47%
1-Year	+7.28%	+17.87%
3-Year	+34.85%	+13.24%

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Novartis AG (NOVN.SW)

Novartis and Medicines for Malaria Venture announce positive efficacy and safety data for a novel treatment for babies <5 kg with malaria

Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Novartis delivers double-digit sales growth and core margin expansion in Q1; FY 2024 guidance raised

Novartis Kesimpta® six-year efficacy data show substantial benefits in recently diagnosed treatment- naïve people with relapsing multiple sclerosis

New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN)

Arvinas Enters into a Transaction with Novartis, including a Global License Agreement for the Development and Commercialization of PROTAC® Androgen Receptor (AR) Protein Degrader ARV-766 for the Treatment of Prostate Cancer

Novartis tender offer for MorphoSys AG commences

New Novartis data show early addition of twice-yearly* Leqvio® (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting

Novartis Fabhalta® (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

Novartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General Meeting

Novartis presents new data on safety and efficacy of Zolgensma, including maintained and improved motor milestones in older and heavier children with SMA

Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys AG for EUR 68 per share or an aggregate of EUR 2.7bn in cash

Novartis delivers strong full year performance, 10% net sales and 18% core operating income growth (cc¹), with margin expansion. Continuing innovation momentum with multiple positive Ph3 readouts

Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors

Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemia

Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis

Novartis investigational iptacopan Phase III study demonstrates clinically meaningful and statistically significant proteinuria reduction in patients with C3 glomerulopathy (C3G)

Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)

Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

Performance Overview