UK markets closed

NOVARTIS AG NOVARTIS ORD SHS (0QLR.IL)

IOB - IOB Delayed price. Currency in CHF
Add to watchlist
81.06-0.20 (-0.25%)
At close: 6:05PM GMT
Full screen
Previous close81.26
Open81.24
Bid0.00 x N/A
Ask0.00 x N/A
Day's range80.52 - 81.53
52-week range65.48 - 96.34
Volume58,812
Avg. volume782,724
Market capN/A
Beta (5Y monthly)N/A
PE ratio (TTM)N/A
EPS (TTM)N/A
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
  • Globe Newswire

    Novartis highlights confidence in growing sales with margin expansion, fueled by in-market brands and a rich pipeline, at Annual Meet the Management investor event

    Novartis showcases unique profile with therapeutic area breadth and depth, exposure to cutting edge platforms and diversification of revenues in terms of assets and geographies Key growth drivers now contributing to 48% of Innovative Medicines sales; upcoming launches expected to lay the foundation for future sales expansion Advancing leading pipeline based on scale, innovation and value which will fuel growth in the mid- to long-term and help offset patent cliffs Committed to driving consistent margin expansion, Innovative Medicines expected to reach high 30s in the mid-term. Target for Novartis Technical Operations productivity program starting in 2021 increased from USD 1.5bn to USD 2bn Laying the foundations for sector leadership in the ESG space Initiating share buyback of up to USD 2.5bn, highlighting confidence in growth Basel, November 24, 2020 — Novartis is hosting today its annual Meet Novartis Management event giving investors and industry analysts the opportunity to meet with key executives across the company. The virtual meeting provides a deeper view into the company's progress on its ongoing transformation and growth strategy focused on becoming the leading medicines company powered by data science and advanced therapy platforms. "Novartis offers a unique profile as a fully focused medicines company with diversification across therapeutic areas and geographies, while providing exposure to cutting-edge platforms. We have delivered strong operational performance, growing the top- and bottom- line and delivering on our commitment to margin expansion. Our rich pipeline continues to advance, and we highlight many assets that show significant promise. Reflecting our confidence in future growth and success of our pipeline, we are initiating a share buyback of up to USD 2.5 billion,” said Novartis CEO, Vas Narasimhan. Novartis has a leading pipeline based on scale, innovation and future value, including 116 assets in phase I or II, 49 in Phase III or undergoing registration and more than 65 new molecular entities. The pipeline is expected to fuel growth in the mid-to long-term, with around 90 percent potential first-in-class/first-in-indication medicines and about 80 percent of targets in areas of high unmet patient need. The company is strengthening its advanced therapy platforms along the value chain with 20 advanced platform therapies in clinical development alongside a large number of pre-clinical projects. Novartis is also making significant progress on the manufacturing and commercialization of these advanced therapy platforms. The total value of estimated sales of products launched from 2020 to 2026 puts Novartis as number two for pipeline replacement power in the global pharmaceutical industry. The company is advancing sustained lifecycle management for many assets with five key programs highlighted at the meeting: Entresto® (sacubitril/valsartan) is under review for the treatment of heart failure with preserved ejection fraction (HFpEF) with a US regulatory decision expected in the first quarter of 2021. Phase III results are expected in the first half of next year from the PARADISE MI trial studying Entresto in patients with acute myocardial infarction (AMI).Cosentyx® (secukinumab) continues to show strength in dermatology and findings from a Phase III trial in hidradenitis suppurativa (HS) are expected in the second half of 2021.Kisqali® (ribociclib) continues to grow in-market with overall survival (OS) data in aBC from the MONALEESA-2 trial anticipated in the second half of 2021. Alpelisib (BYL719) is on track for a US submission in PIK3CA-Related Overgrowth Spectrum (PROS) in 2021. Beovu® (brolucizumab) is progressing in Phase III development for diabetic macular edema (DME) with a potential submission planned in 2021. From the many assets in the Pharmaceuticals business unit, Novartis is also highlighting multiple mid- to late-stage assets with key milestones expected in 2021 and 2022: Iptacopan (LNP023), a potential first-in-class oral factor B inhibitor in development for several rare renal diseases and a hematological disorder, is expected to begin Phase III development for IgA Nephropathy (IgAN) in the first half of 2021. The European Medicines Agency (EMA) has granted orphan drug designation to iptacopan for the treatment of IgAN and PRIME designation in C3G.Iscalimab (CFZ533) is an anti-CD40 antibody in development across multiple indications including Sjögren’s syndrome, kidney and liver transplantation; with first results expected in 2022.The Phase III clinical trials for the next-generation anti-IgE/FcεRI antibody ligelizumab (QGE031) in chronic spontaneous urticaria (CSU) are fully enrolled, with results expected in the second half of 2021 and regulatory submission in 2022. In December 2019, Novartis initiated a Phase III outcomes study for pelacarsen (TQJ230), a potential first-in-class antisense oligonucleotide for secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a). Results are expected in 2024. Inclisiran (Leqvio®) has received positive CHMP opinion for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, marking an important milestone towards it becoming potentially available in the EU. Currently under regulatory review with the FDA with an action date of December 2020.The FDA granted orphan drug designation for the company’s orally administered, small molecule RNA splicing modulator branaplam (LMI070) for the treatment of Huntington’s disease (HD). A Phase IIb study in HD patients is planned to begin in the first half of 2021. From its broad portfolio in the Oncology business unit, Novartis is also highlighting five mid- to late-stage assets with key milestones expected in 2021: The Phase III program for canakinumab (ACZ885) in non-small cell lung cancer (NSCLC) is progressing with final results expected from the CANOPY-1 and CANOPY-2 trials in the second and first half of 2021 respectively.Results from the Phase III VISION trial for 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer (mCRPC 3L) are expected in the first half of 2021.Sabatolimab (MBG453), an anti-TIM-3 monoclonal antibody, makes progress in a Phase III trial in high risk myelodysplastic syndrome (HR-MDS), and a potential first submission is anticipated in the second half of 2021. TNO155, a SHP2 inhibitor, is advancing in early clinical trials with a broad combination strategy for KRAS G12C mutant NSCLC and other solid tumors.LXH254, a selective B/C RAF inhibitor, is making progress in multiple combination studies in NRAS and BRAF mutant melanomas and in certain forms of lung cancers. For Sandoz, management provides an update on progress against its strategy. Recent successes include increasing biosimilar market share in Europe, expansion of gross margin, joint investment to drive sustainable production of antibiotics and strategic deals in the US and Japan. Sandoz is now the only generics company with a top three position in all major regions (US, Europe, ROW). The division continues to target sustained industry leadership, with growth driven primarily by biosimilars, based on a strong pipeline of more than 15 molecules, and a goal to achieve margins in the mid to high 20s range. Sandoz also continues to drive value for society, reaching well over 500 million patients annually, playing a leading role in generating generic savings for healthcare systems worldwide.   The announced share buyback of up to USD 2.5 billion will be executed under the existing annual general meeting authority, starts immediately and will last into the first half of 2021. The program is supported by Novartis’ liquidity and strong balance sheet, in line with our capital structure reflecting AA- (S&P) / A1 (Moody’s) credit rating, and existing capital allocation priorities. Novartis is committed to driving constant margin expansion and is on track to deliver USD 2 billion cost savings by year-end across Novartis Technical Operations and Novartis Business Services. Novartis Technical Operations also has productivity programs in place that are set to further generate around USD 2 billion in cost reduction in the mid-term. In the Environment, Social, Governance (ESG) space, Novartis has taken significant steps to achieve its objective of becoming one of the leaders in the sector. Key developments in the last 12 months include the resolution of material legacy compliance issues and the launch of the Code of Ethics, expanded Diversity and Inclusions efforts across all operations, as well as the issuance of the first-of-its–kind sustainability bond in the pharmaceutical industry. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “pipeline,” “potential,” “confidence,” “launch,” “launched,” “launches,” “will,” “driving,” “strategy,” “development,” “planned,” “continues,” “sustainable,” “on track,” “to deliver,” “future,” “milestones,” “focused,” “growing,” “advancing,” “committed,” “initiating,” “ongoing,” “commitment,” “advancing,” “progressing,” “expected,” “to achieve,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products; or regarding potential future sales or earnings of the Group or any of its divisions or potential shareholder returns; or regarding the potential impact of the share buyback plan; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the inherent uncertainties involved in predicting shareholder returns; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com # # # Novartis Media RelationsE-mail: media.relations@novartis.com Antonio LigiNovartis External Communications+41 61 324 1374 (direct)antonio.ligi@novartis.com   Eric AlthoffNovartis US External Communications+1 646 438 4335eric.althoff@novartis.com   Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central   North America   Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052 Thomas Hungerbuehler         +41 61 324 8425     Isabella Zinck +41 61 324 7188

  • Globe Newswire

    Novartis secures exclusive rights for potential acute respiratory distress syndrome cell therapy

    Novartis enters into exclusive worldwide license with Mesoblast to develop, commercialize and manufacture remestemcel-L for treatment of acute respiratory distress syndrome (ARDS) and other indicationsAddition of remestemcel-L could expand Novartis respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential Deal includes $50 million upfront cash payment and equity/share subscription, plus performance-based milestones and royalties for access to a cell-therapy based platform with worldwide rights to a range of potential indications Basel, November 19, 2020 — Novartis announced today that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which includes prolonged ICU treatment and mechanical ventilation.1,2 As the potential first ARDS therapy, remestemcel-L will use mesenchymal stromal cells (MSCs), a cell-based platform technology, to treat this deadly condition and improve outcomes. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing 300-patient Phase III study.3 Novartis intends to initiate a Phase III study in non-COVID-19-related ARDS after the anticipated closing of the license agreement and successful completion and outcome of the current study. “We believe that Novartis is uniquely placed to advance this important potential new therapy,” said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer for Novartis. “Novartis is committed to, and has demonstrated success with, cell-based therapies and transforming care for a spectrum of respiratory diseases. This makes remestemcel-L an important addition to our pipeline. It has the potential to be the first treatment for the most critically ill ARDS patients, and it provides us with an opportunity to apply years of specialized experience directly to the work of saving lives.” The demonstrated ability of Novartis to rapidly move from clinical to commercial scale with cell-based therapies will play a role in the successful development and potential commercialization of remestemcel-L, as will the nearly two decades of experience Novartis has in delivering first-in-class products that address areas of unmet respiratory need. In March, an open label compassionate use program was conducted, which included 12 patients with COVID-19-related ARDS, who were being supported with mechanical ventilation. Remestemcel-L treatment was associated with an 83% survival rate.4 Based on those results, remestemcel-L is being studied in this population in an ongoing 300-patient Phase III study, conducted in collaboration with the Cardiothoracic Surgical Network, which is anticipated to be completed in early 2021.3 After the anticipated closing of the license agreement and successful completion and outcome of this ongoing study, Novartis and Mesoblast will work together to develop appropriate critical quality attributes that meet U.S. Food and Drug Administration requirements for remestemcel-L in advance of initiation of the Phase III study in non-COVID-19-related ARDS.   Under the license agreement, Novartis will acquire the exclusive worldwide rights to develop, commercialize and manufacture remestemcel-L for ARDS, and will obtain access to an innovative cell-therapy platform with a range of potential applications in severe respiratory conditions and beyond. Novartis will make a $25 million upfront payment and invest $25 million in Mesoblast equity with additional payments and royalties due on achievement of agreed development, regulatory and commercial milestones. In addition, Novartis will provide certain support to enable commercial manufacturing scale-up. Novartis has the option, if exercised, to distribute remestemcel-L for graft versus host disease (GVHD) (outside Japan). Both parties have rights to co-fund development and commercialization for other non-respiratory indications. The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions. About remestemcel-L Remestemcel-L, is an investigational therapy comprising of culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor.5 Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.5 In the Phase III study in COVID-19-related ARDS, remestemcel-L is administered as two infusions of 2x106 MSC/kg given three to four days apart.3 The administration of remestemcel-L for the treatment of all-cause ARDS could be the subject of further exploration. About mesenchymal stromal cells   Mesenchymal stromal cells (MSCs) are isolated from bone marrow, adipose tissue and other sources that can be expanded in culture to larger quantities.6 In preclinical studies MSCs have been suggested to transiently accumulate in the pulmonary circulation and have potent immunomodulatory functions.7 They express receptors for multiple chemokine, cytokine and growth factor receptors and in inflammatory conditions secrete immunomodulatory mediators that have broad-acting effects to promote resolution of inflammation and tissue repair.8 MSCs have been infused into well over 1,000 patients, including young children, without serious adverse events to date, testifying to the general safety of this therapeutic approach.9 About acute respiratory distress syndrome Acute respiratory distress syndrome (ARDS) is a clinical syndrome that represents a final common pathway for lung injury caused by a variety of factors including bacterial and viral infection (including COVID-19).2  It is characterized by life threatening hypoxemia and bilateral pulmonary infiltrates without evidence of cardiac failure.10 Mortality often exceeds 40%.2 Aside from appropriate ventilator and fluid management, no therapies have been shown to consistently improve survival in randomized clinical trials.8,11 DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “may,” “could,” “anticipated,” “believe,” “committed,” “investigational,” “pipeline,” “to develop,” “intends,” “to initiate,” “anticipated,” “advances,” “bringing forward,” “to lead,” “development,” “ongoing,” “to address,” “intends,” “to enable,” or similar terms, or by express or implied discussions regarding potential marketing approvals or labeling for remestemcel-L, or regarding potential future revenues from remestemcel-L; or regarding the worldwide license and collaboration agreement to develop, commercialize and manufacture remestemcel-L. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the transaction described in this press release will be completed in the expected time frame, or at all. Neither is there any guarantee that the expected benefits and synergies from such transaction will be achieved in the expected timeframe, or at all. Nor can there be any guarantee that remestemcel-L will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that remestemcel-L will be commercially successful in the future. In particular, our expectations regarding the transaction described in this press release and remestemcel-L could be affected by, among other things, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and satisfaction of certain other closing conditions; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visit https://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com References Tzotzos SJ, Fischer B, Fischer H, Zeitlinger M. Incidence of ARDS and outcomes in hospitalized patients with COVID-19: a global literature survey. Crit Care. 2020;24(1):516. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7441837/Matthay MA, Zemans RL. The acute respiratory distress syndrome: pathogenesis and treatment. Annu Rev Pathol. 2011;6:147-163. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108259/MSCs in COVID-19 ARDS. ClinicalTrials.gov identifier: NCT04371393. https://www.clinicaltrials.gov/ct2/show/NCT04371393Mesoblast Ltd. 83% Survival in COVID-19 Patients with Moderate/Severe Acute Respiratory Distress Syndrome Treated in New York with Mesoblast’s cell therapy Remestemcel-L.; 2020 https://investorsmedia.mesoblast.com/static-files/337e723a-340d-493e-a4a1-0971d2c71460National Health Service - National Institute for Health Research. Remestemcel-L (Prochymal) for steroid refractory acute graft versus host disease – second line.; 2015 http://www.io.nihr.ac.uk/wp-content/uploads/migrated/Remestemcel-L-July2015.pdfFitzsimmons REB et al. Mesenchymal Stromal/Stem Cells in Regenerative Medicine and Tissue Engineering. Stem Cells Int. 2018;2018:8031718. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6120267/Gotts JE, Matthay MA. Mesenchymal stem cells and acute lung injury. Crit Care Clin. 2011;27(3):719-733. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134785/Horwitz EM, Andreef M, Frassoni F. Mesenchymal stromal cells. Curr Opin Hematol. 2006;13(6):419-425. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3365862/Thompson M et al. Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis. EClinicalMedicine. 2020;19, https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30258-5/fulltextDiamond M, Peniston Feliciano HL, Sanghavi D, et al. Acute Respiratory Distress Syndrome. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK436002/Cepkova M, Matthay MA. Pharmacotherapy of acute lung injury and the acute respiratory distress syndrome. J Intensive Care Med. 2006;21(3):119-143. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2765330/ # # # Novartis Media RelationsE-mail: media.relations@novartis.com Peter ZuestNovartis External Communications+41 79 899 98 12 (mobile)peter.zuest@novartis.com Novartis US External Communications+1 646 438 43 35eric.althoff@novartis.comPhil McNamaraGlobal Head, Respiratory Communications+41 79 510 87 56 (mobile)philip.mcnamara@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052Thomas Hungerbuehler        +41 61 324 8425  Isabella Zinck+41 61 324 7188

  • New data at ASH to reinforce breadth of Novartis hematology portfolio across multiple blood cancers and serious hematologic diseases
    Globe Newswire

    New data at ASH to reinforce breadth of Novartis hematology portfolio across multiple blood cancers and serious hematologic diseases

    Pivotal ASCEMBL study of novel, investigational STAMP inhibitor asciminib (ABL001) vs. bosutinib in CML patients previously treated with two or more TKIs ELARA results for Kymriah® in relapsed or refractory (r/r) follicular lymphoma, plus long-term JULIET data on response survival and durability at more than three years in r/r DLBCL patients Detailed Jakavi® analysis from REACH3 in steroid-refractory chronic GvHD, building on previously reported positive REACH2 results in steroid-refractory acute GvHD New data for sabatolimab (MBG453) and Adakveo® (crizanlizumab) underscore breadth of Novartis innovation in hematology The digital press release with multimedia content can be accessed here:   Basel, November 19, 2020 — Novartis announced today that new research data from a broad range of hematology medicines and investigational therapies will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, taking place virtually December 5-8. More than 65 abstracts from Novartis-sponsored and investigator-initiated trials that include results for asciminib (ABL001), Kymriah® (tisagenlecleucel), Jakavi® (ruxolitinib)*, sabatolimab (MBG453) and Adakveo® (crizanlizumab) underscore the Novartis vision to deliver transformative innovation to address unmet medical needs. “Our research and development strategy focuses on developing transformative treatments with the aspiration of dramatically improving quality of life and addressing the underlying disease process,” said Susanne Schaffert, PhD, President, Novartis Oncology. “The ASH presentations demonstrate how we are pursuing these goals in hematology with research that focuses on developing advanced therapeutic approaches across an array of blood cancers and difficult-to-treat hematologic diseases.” Key highlights of data accepted by ASH: Novel, investigational STAMP inhibitor asciminib (ABL001) evaluated for safety and efficacy for TKI-resistant and intolerant CML patients: Efficacy and Safety Results From ASCEMBL, a Multicenter, Open-label, Phase 3 Study of Asciminib vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Previously Treated with ≥2 Tyrosine Kinase Inhibitors (TKIs) [Abstract #LBA-4; oral presentation; Tuesday, December 8, 8:15 AM PST]Asciminib, a First-in-Class STAMP Inhibitor, Provides Durable Molecular Response in Patients (Pts) With Chronic Myeloid Leukemia (CML) Harboring the T315I Mutation: Primary Efficacy and Safety Results From a Phase 1 Trial [Abstract #650; oral presentation: Monday, December 7, 12:15 PM PST]Structural and Biochemical Studies Confirming the Mechanism of Action of Asciminib, an Agent Specifically Targeting the ABL Myristoyl Pocket (STAMP) [Abstract #3961; online publication] New data for the first anti-TIM-3 antibody in hematology, sabatolimab (MBG453): Efficacy and Safety of Sabatolimab (MBG453) in Combination With Hypomethylating Agents (HMAs) in Patients With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS): Updated Results From a Phase 1b Study [Abstract #657; oral presentation: Monday, December 7, 12:30 PM PST]Sabatolimab (MBG453) Dose Selection and Dose-Response Analysis in Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML): Population Pharmacokinetics (PK) Modeling and Evaluation of Clinical Efficacy/Safety by Dose [Abstract #2192; poster presentation: Sunday, December 6, 7:00 AM PST] Kymriah® (tisagenlecleucel) results from the first analysis of the Phase II ELARA trial in r/r follicular lymphoma and a clinical update of 40-month median follow-up from the pivotal JULIET trial in r/r diffuse large B-cell lymphoma (DLBCL): Efficacy and Safety of Tisagenlecleucel in Adult Patients With Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 ELARA Trial [Abstract #1149; poster presentation: Saturday, December 5, 7:00 AM PST]Myc Expression and Tumor-Infiltrating T Cells Are Associated With Response in Patients (Pts) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) Treated With Tisagenlecleucel in the JULIET Trial [Abstract #1194; poster presentation: Saturday, December 5, 7:00 AM PST] Adakveo® (crizanlizumab) results from the SOLACE trial and a post-hoc analysis of the SUSTAIN trial for vaso-occlusive pain crises in sickle cell disease, and extended results from the Sickle Cell World Assessment Survey (SWAY): Pharmacokinetics/Pharmacodynamics, Safety and Efficacy of Crizanlizumab in Patients With Sickle Cell Disease and a History of Vaso-Occlusive Crises: Results From the Phase II, Multicenter, Open-Label SOLACE-Adults Study [Abstract #1715; poster presentation: Sunday, December 6, 7:00 AM PST]The Effect of Crizanlizumab on the Number of Days Requiring Opioid Use for Management of Pain Associated With Vaso-Occlusive Crises in Patients With Sickle Cell Disease: Results From the SUSTAIN Trial [Abstract #796; poster presentation: Saturday, December 5, 7:00 AM PST]Global Treatment Satisfaction Levels and Treatment Patterns From the International Sickle Cell World Assessment Survey (SWAY): Hydroxyurea (HU) Versus No HU [Abstract #17; oral presentation: Saturday, December 5, 8:30 AM PST] Primary findings from the REACH3 trial for steroid-refractory chronic graft-vs-host disease (GvHD) and additional findings from REACH2 for steroid-refractory acute GvHD treated with Jakavi® (ruxolitinib)*: Ruxolitinib vs Best Available Therapy in Patients With Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease: Primary Findings From the Phase 3, Randomized REACH3 Study [Abstract #77; oral presentation: Saturday, December 5, 8:00 AM PST]Biomarker Analysis in Patients With Steroid-Refractory Acute Graft vs Host Disease Treated With Ruxolitinib or Best Available Therapy in the Randomized, Phase 3 REACH2 Study [Abstract #1519; poster presentation: Saturday, December 5, 7:00 AM PST]Safety Analysis of Ruxolitinib (RUX) vs Best Available Therapy in Patients With Steroid-Refractory Acute Graft-vs-Host Disease in the Randomized Phase 3 REACH2 Study [Abstract #2440; poster presentation: Sunday, December 6, 7:00 AM PST] Early pipeline results for ianalumab (VAY736) in chronic lymphocytic leukemia: Phase Ib Study of Ianalumab (VAY736) and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy [Abstract #1309; poster presentation: Saturday, December 5, 7:00 AM PST] Product InformationApproved indications for products vary by country and not all indications are available in every country. Safety and efficacy profiles have not been established for investigational compounds or are outside the approved indications for marketed products. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available or receive additional indications if already marketed. For full prescribing information including important safety information about marketed products, please visit https://www.novartis.com/our-company/global-product-portfolio. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visit https://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com # # # Novartis Media RelationsE-mail: media.relations@novartis.com Anja von TreskowNovartis External Communications+41 61 324 2279 (direct)+41 79 392 8697 (mobile)anja.von_treskow@novartis.com   Julie MasowNovartis Oncology Media Relations+1 862 579 8456julie.masow@novartis.com   Eric AlthoffNovartis US External Communications+1 646 438 4335eric.althoff@novartis.com   Michael BillingsNovartis Oncology Communications+1 201 400 1854 (mobile)michael.billings@novartis.com   Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central   North America   Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052 Thomas Hungerbuehler        Isabella Zinck +41 61 324 8425+41 61 324 7188