Media Release Cancer Local Impact Innovation Reimagine Medicine Basel, May 7, 2026 – Novartis, a leading global innovative medicines company, today broke ground on its new 46,000 sq. ft radioligand therapy (RLT) manufacturing site in Denton, Texas, the latest milestone in its broader $23 billion investment in US manufacturing and research. The start of construction on the company’s first Texas‑based manufacturing facility brings US RLT production closer to patients across the southern US, becoming the fifth RLT site nationwide.

“Radioligand therapy is transforming how we treat cancer, and expanded manufacturing is essential to delivering these therapies at scale,” said Vas Narasimhan, CEO of Novartis. “Breaking ground in Denton further strengthens our US supply chain and helps ensure patients can receive these highly personalized treatments when and where they need them.”

This expansion reinforces Novartis’ leadership as the first company to deliver RLT at scale, building the network capacity needed as these therapies extend into earlier stages of treatment and a broader range of cancers. Announced earlier this year, the site is expected to become operational in 2028 and create new US-based Novartis jobs in bioengineering, advanced manufacturing, quality, and operations, supporting economic growth in Denton and surrounding communities. 

US Under Secretary of Commerce for Industry and Security Jeffrey Kessler, Swiss Ambassador to the US Ralf Heckner, Texas State Senator Brent Hagenbuch, Texas State Representative Andy Hopper, and Denton Mayor Gerard Hudspeth joined Novartis leadership, employees, and community partners to celebrate the start of construction. 

“I’m pleased to welcome Novartis to Denton as their newest manufacturing location for their cancer therapies,” said Texas State Senator Brent Hagenbuch. “Their decision establishes a strong partnership and reflects the unique opportunity Denton provides to a well-educated workforce, and the unique access the new plant location will provide to the vibrant North Texas economy and rapidly growing state population.”

The Texas facility bolsters the Novartis coast-to-coast RLT manufacturing network, with existing US sites in New Jersey, Indiana and California, and a new site being added in Florida. The Denton site adds to the largest US RLT manufacturing network and further builds on the company’s longstanding track record of enabling >99% of doses to be administered on the planned day of treatment. Each dose of RLT is custom-made and requires precise coordination, making manufacturing reliability and proximity to treatment centers critical to delivering treatment as planned.

In April 2025, Novartis committed $23 billion over five years to grow its US research and manufacturing footprint. Seven new and three expanded facilities across the country are already under construction – part of the company’s broader effort to manufacture all key medicines for US patients in the US, supporting supply resilience and dependable delivery of medicines. The Denton groundbreaking builds on rapid progress across Novartis’ US investment plan.

]]> Media Release Clinical Trials Local Impact Scientific Discoveries Reimagine Medicine Basel, April 30, 2026 – Novartis today announced plans to add a new facility in Morrisville, North Carolina, focused on active pharmaceutical ingredient (API) manufacturing for solid dosage tablets, capsules and RNA therapeutics. The facility represents a critical step that will strengthen end‑to‑end US production capability from active ingredients through finished medicines.

This announcement marks the company’s seventh new facility planned within a year of its announced $23 billion investment in US-based manufacturing, research and development. The 56,200-square-foot facility will expand the company’s presence in North Carolina to five facilities across three sites. The infrastructure will support not only today’s medicines, but also the development and delivery of future innovative therapies for US patients.

“Last year we committed to adding seven new facilities in the US, and today we finalize our plans to expand our US manufacturing and R&D footprint in the US,” said Vas Narasimhan, CEO of Novartis. "By building a connected, end-to-end footprint, we are strengthening our ability to locally develop, produce, and deliver medicines at scale, enabling timely access to innovation for patients in the US.”

Since April 2025, Novartis has made significant progress on its commitment to manufacture all key Novartis medicines for US patients in the US. These investments are expanding capacity and building the foundation to deliver advanced therapies to the patients who rely on them, including time-sensitive treatments like radioligand therapies (RLT).

]]> Media Release Ad Hoc Reimagine Medicine Medical Innovations Ad hoc announcement pursuant to Art. 53 LR

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Erstes Quartal

]]> Media Release Chronic Illness Reimagine Medicine Innovation Targeted Therapy Basel, April 27, 2026 – Novartis announced today that the European Commission (EC) approved Rhapsido^® (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. Rhapsido is the first oral targeted treatment approved for CSU, offering a unique approach to CSU treatment in a pill taken twice daily without any lab monitoring required¹.

]]> Media Release Reimagine Medicine Neuroscience Cell and Gene Therapy Rare Diseases Basel, April 24, 2026 – Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Itvisma^® (intrathecal onasemnogene abeparvovec). The opinion supports its use for the treatment of children two years and older, teens, and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene.

]]> Media Release Tropical Diseases Basel, April 24, 2026 – Novartis today announced that the World Health Organization (WHO) has prequalified Coartem® (artemether-lumefantrine) Baby, the first and only antimalarial developed specifically for newborns and young infants weighing from 2 to 5 kilograms. The decision is a key step towards enabling widespread access through public sector procurement. Coartem Baby is also known as Riamet® Baby in some countries and was developed in collaboration with Medicines for Malaria Venture (MMV).

]]> Media Release Cancer Innovation Social Commitment Reimagine Medicine Basel, April 9, 2026 – Novartis today announced the expansion of its programs to find and treat patients with heart disease and cancer in hard-to-reach communities around the world. This comes as public health efforts against chronic diseases slow or reverse in many countries.¹ Three distinct Novartis community health approaches focused on closing gaps in care for low-income, rural and other communities will nearly triple from 11 to more than 30 countries by 2030, including:

]]> Media Release Clinical Trials Rare Diseases Reimagine Medicine Basel, March 29, 2026 – Novartis today announced final two-year results from the Phase III APPLAUSE‑IgAN study of Fabhalta^® (iptacopan) in IgA nephropathy (IgAN). Fabhalta demonstrated a statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope, a key marker of kidney function, compared with placebo¹. Fabhalta consistently outperformed placebo across key kidney outcomes over two years, demonstrating a slowing of disease progression and the potential to preserve kidney function in IgAN¹.

The results were published in the New England Journal of Medicine and simultaneously presented as late‑breaking data at the 2026 World Congress of Nephrology (WCN).

]]> Media Release Immunology Reimagine Medicine Innovation - Proposed acquisition strengthens Novartis immunology strategy in food allergy and other IgE-driven diseases
   
- Lead asset Exl-111 builds on proven IgE biology with a differentiated mechanism designed to dissociate receptor-bound IgE and drive faster, deeper pathway suppression
   
- Exl-111 would complement existing Novartis portfolio in allergy with potential to improve both symptom control and convenience
  
Basel, March 27, 2026 – Novartis today announced that it has entered into an agreement to acquire Excellergy, Inc., a private biotech company developing next-generation anti-IgE therapies for IgE-driven diseases. The proposed acquisition adds Exl-111, a half-life extended, high-affinity anti-IgE antibody in Phase 1.
   
The acquisition builds on deep Novartis expertise in IgE biology and a long-standing presence in allergic disease. Exl-111 is designed as a next-generation extension of validated biology established by anti-IgE therapy, with the potential to complement the Novartis existing allergy portfolio across a range of allergic conditions and patient settings.
  
“Excellergy adds a differentiated next-generation anti-IgE program that builds on biology Novartis knows well, supported by preclinical evidence and early clinical pharmacokinetic data,” said Fiona Marshall, President of Biomedical Research at Novartis. “Exl-111 is designed to go beyond conventional anti-IgE therapy, with the potential to deliver faster and deeper suppression of IgE signaling as well as improved symptom control. This proposed acquisition strengthens our allergy portfolio and reflects our strategy of advancing innovative bold science to bring meaningful additional benefits to patients.” 
  
IgE is a central driver of multiple allergic diseases. Unlike conventional anti-IgE approaches, Exl-111 is designed to dissociate receptor-bound IgE with the potential to drive faster and deeper Fc epsilon RI alpha (FcεRIα) downregulation. Preclinical studies and early human pharmacokinetic data from ongoing Phase 1 evaluation support a differentiated profile, with evidence of sustained exposure consistent with its half‑life‑extended design. If confirmed clinically, this mechanism could support earlier symptom relief, stronger disease control, more convenient dosing and broader use across food allergy, chronic spontaneous urticaria, chronic inducible urticaria, allergic asthma and other IgE-mediated diseases, including potentially in pediatric populations.
  
Transaction Details
Under the terms of the agreement, Novartis will pay up to USD 2 billion in upfront and milestone payments to acquire Excellergy. The transaction is expected to close in H2 2026, subject to the satisfaction or waiver of customary closing conditions, including regulatory approvals.
  
About Novartis Immunology
At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.
  
About Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.
  
Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.
  
Disclaimer
  
This 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,” “look forward,” or similar expressions, or by express or implied discussions regarding: potential new products or programs, including Exl-111, potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions, including the acquisition of Excellergy, Inc.; or potential future sales or earnings. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 Exl-111 will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all, nor can there be any guarantee that Exl-111 will be commercially successful in the future. In particular, our expectations regarding Exl-111 or the transaction described in this press release could be affected by, among other things, the satisfaction of customary closing conditions including regulatory approvals, as well as uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, 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 as a result of new information, future events or otherwise.

]]> Media Release Reimagine Medicine Chronic Illness Clinical Trials Innovation
Basel, March 23, 2026 – Novartis will present data from more than 20 abstracts from its growing immunology portfolio at this year’s American Academy of Dermatology (AAD) Annual Meeting.

]]> Media Release Reimagine Medicine Medical Innovations Oncology Cancer Basel, March 20, 2026 – Novartis today announced that it has entered into an agreement with Synnovation Therapeutics, LLC to acquire SNV4818, a pan-mutant‑selective PI3Kα inhibitor, exploring a next-generation approach for the treatment of patients with HR+/HER2- breast cancer and potentially other solid tumor indications.

]]> Media Release Reimagine Medicine Innovation Chronic Illness Basel, March 13, 2026 – Novartis announced today that Cosentyx^® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population¹. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx as a meaningful addition to the treatment landscape^1-13.

]]> Media Release Reimagine Medicine Basel, March 6, 2026 – Novartis shareholders today agreed to the Board of Directors’ recommendations for all proposed resolutions at the company’s Annual General Meeting (AGM). A total of 1 554 shareholders were present at the meeting held in Basel, representing approximately 59.15% of the issued shares of Novartis.

With a dividend increase of 5.7% to CHF 3.70 per share, shareholders approved the 29^th consecutive increase, resulting in a dividend yield of 3.0%¹. Payment of the 2025 dividend will be made from March 12, 2026.

Election of a new member of the Board of Directors
Shareholders have re-elected Giovanni Caforio as member of the Board of Directors and Board Chair.

In addition, shareholders elected Charles Swanton as new member of the Board of Directors. Daniel Hochstrasser did not stand for re-election. All other members of the Board of Directors have been re-elected. All elections and re-elections pertain to a term lasting until the completion of the next AGM. 

Shareholders also re-elected all current members of the Compensation Committee and elected Elizabeth McNally as new member of the Compensation Committee, each until the end of the next AGM. With his re-election, Simon Moroney remains Chair of the Committee in line with the designation from the Board of Directors.

Reduction of share capital
Shareholders approved the proposal by the Board of Directors to cancel 77 602 358 shares and to reduce the share capital accordingly by CHF 38 025 155.42 (from CHF 1 035 086 714.83 to CHF 997 061 559.41).

Compensation for the Board of Directors and the Executive Committee
In two separate binding votes, shareholders approved the total maximum aggregate amount of compensation for the Board of Directors, covering the period from the 2026 AGM to the 2027 AGM, and the total maximum aggregate amount of compensation for the Executive Committee for the 2027 financial year. Shareholders further endorsed the 2025 Compensation Report in an advisory vote.

Resolutions
For a detailed listing of all resolutions at the 2026 AGM, please visit: https://novartis.com/agm

Disclaimer
This 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 “future,” “proposed,”  “will,” or similar terms, or by express or implied discussions regarding the potential future impact of the matters described in this press release, including the future commercial performance of Novartis, future reductions in share capital, the annual re-election and election of members of the Board of Directors and committees of the Board, and votes on compensation for the members of the Board of Directors and the Executive Committee. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 as to the ultimate outcome of the matters described in this press release or their potential impact on Novartis. In particular, our expectations regarding these matters could be affected by, among other things, uncertainties concerning: global healthcare cost containment; the success of key products, commercial priorities and strategy; research and development of new products; our ability to obtain or maintain proprietary intellectual property protection; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence; potential significant breaches of information security; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world;   and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, 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 Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References
1. Based on the Novartis SIX Swiss Exchange closing share price of CHF 124.82 on March 5, 2026

]]> Media Release Reimagine Medicine Basel, 6. März, 2026 – Die Aktionärinnen und Aktionäre von Novartis stimmten heute an der Generalversammlung (GV) des Unternehmens allen Vorschlägen des Verwaltungsrats zu. Insgesamt waren 1 554 Aktionärinnen und Aktionäre bei der in Basel abgehaltenen Versammlung anwesend, was rund 59,15% der von Novartis ausgegebenen Aktien entspricht.

Mit einer Dividendenerhöhung um 5,7% auf CHF 3.70 je Aktie genehmigten die Aktionärinnen und Aktionäre die 29. Erhöhung in Folge, die zu einer Dividendenrendite von 3,0%¹ führt. Die Auszahlung der Dividende für das Jahr 2025 erfolgt per 12. März 2026.

Wahl eines neuen Mitglieds des Verwaltungsrats 
Die Aktionärinnen und Aktionäre haben Giovanni Caforio als Mitglied des Verwaltungsrats und als Präsidenten des Verwaltungsrats wiedergewählt.

Zudem wählten sie Charles Swanton neu in den Verwaltungsrat. Daniel Hochstrasser stellte sich nicht zur Wiederwahl. Alle weiteren Mitglieder des Verwaltungsrats wurden wiedergewählt. Die Amtszeit der gewählten und wiedergewählten Mitglieder dauert bis zum Abschluss der nächsten ordentlichen GV.

Die Aktionärinnen und Aktionäre stimmten zudem für die Wiederwahl aller derzeitigen Mitglieder des Vergütungsausschusses sowie für die Wahl von Elizabeth McNally als neues Mitglied des Vergütungsausschusses – jeweils für eine Amtszeit bis zum Abschluss der nächsten ordentlichen GV. Simon Moroney bleibt mit seiner Wiederwahl Vorsitzender des Vergütungsausschusses, entsprechend der Benennung durch den Verwaltungsrat.

Herabsetzung des Aktienkapitals
Im Einklang mit der Empfehlung des Verwaltungsrats genehmigten die Aktionärinnen und
Aktionäre zudem die Vernichtung von 77 602 358 Aktien und die entsprechende Herabsetzung des Aktienkapitals um CHF 38 025 155.42 (von CHF 1 035 086 714.83 auf CHF 997 061 559.41).

Vergütung des Verwaltungsrats und der Konzernleitung
In zwei getrennten verbindlichen Abstimmungen genehmigten die Aktionärinnen und Aktionäre den maximalen Gesamtbetrag für die Vergütung des Verwaltungsrats für den Zeitraum ab der GV 2026 bis zur GV 2027 sowie den maximalen Gesamtvergütungsbetrag für die Mitglieder der Konzernleitung für das Geschäftsjahr 2027. In einer Konsultativabstimmung bestätigten sie auch den Vergütungsbericht 2025.

Anträge
Eine detaillierte Auflistung aller Beschlüsse der ordentlichen GV 2026 finden Sie unter: General Meetings | Novartis

Disclaimer
Diese Mitteilung enthält in die Zukunft gerichtete Aussagen, die bekannte und unbekannte Risiken, Unsicherheiten und andere Faktoren beinhalten, die zur Folge haben können, dass die tatsächlichen Ergebnisse wesentlich von den erwarteten Ergebnissen, Leistungen oder Errungenschaften abweichen, wie sie in den zukunftsbezogenen Aussagen enthalten oder impliziert sind. Einige der mit diesen Aussagen verbundenen Risiken sind in der englischsprachigen Version dieser Mitteilung und dem jüngsten Dokument ‹Form 20-F› der Novartis AG, das bei der ‹US Securities and Exchange Commission› hinterlegt wurde, zusammengefasst. Dem Leser wird empfohlen, diese Zusammenfassungen sorgfältig zu lesen.

Über Novartis 
Novartis ist ein Unternehmen, das sich auf innovative Arzneimittel konzentriert. Jeden Tag arbeiten wir daran, Medizin neu zu denken, um das Leben der Menschen zu verbessern und zu verlängern, damit Patienten, medizinisches Fachpersonal und die Gesellschaft in der Lage sind, schwere Krankheiten zu bewältigen. Unsere Medikamente erreichen mehr als 300 Millionen Menschen weltweit. 

Entdecken Sie mit uns die Medizin neu: Besuchen Sie uns unter https://www.novartis.com und bleiben Sie mit uns auf LinkedIn, Facebook, X/Twitter und Instagram in Verbindung.

Referenzen

]]> Media Release Reimagine Medicine Medical Innovations Neuroscience
Basel, February 27, 2026 -- Novartis AG (NYSE: NVS) today announced that it has successfully completed its acquisition of Avidity Biosciences, Inc. (“Avidity”). With the completion of the acquisition, Avidity is now an indirect, wholly owned subsidiary of Novartis.

]]> Media Release Innovation Chronic Illness Reimagine Medicine Targeted Therapy Basel, February 27, 2026 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for remibrutinib. The opinion supports its use as an oral treatment for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1‑antihistamine treatment.

“The introduction of remibrutinib represents a major advancement, providing clinicians with an oral Bruton’s tyrosine kinase inhibitor (BTKi) treatment, with improvements in symptoms observed as early as Week 1,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin. “CSU continues to impose a substantial unmet medical need, as many patients struggle to achieve adequate disease control with currently available therapies.”

The positive CHMP opinion is supported by results from the pivotal REMIX-1 and REMIX-2 Phase III trials. Remibrutinib showed improvements in itch and hives as early as Week 1, with benefits sustained through Week 52¹. Improvements in quality of life and sleep were also observed early in treatment ¹. Remibrutinib was well tolerated and demonstrated a favorable safety profile, including no liver safety concerns across both studies through Week 52¹.

“People living with CSU often endure years of frustration, and difficulty being taken seriously. For many, the unpredictable itch flare‑ups can make it hard to sleep, focus on daily responsibilities, or even perform their jobs at times,” said Tonya Winders, President and CEO, Global Allergy & Airways Patient Platform (GAAPP). “The arrival of a new oral treatment option brings us one step closer to ensuring that every person has the opportunity to live fully again.”

“Today’s positive CHMP opinion is an important step towards addressing the significant unmet needs of adults living with CSU in Europe,” said Patrick Horber, M.D., President, International, Novartis. “We will continue to collaborate with regulatory authorities globally to make this important medicine, discovered and developed by Novartis, available to patients who need it most.”

Following the CHMP recommendation for approval, the European Commission (EC) is expected to issue a final decision within approximately two months.

About remibrutinib
Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of itchy hives (wheals) and swelling^5-7. By reducing histamine release, remibrutinib helps relieve the symptoms of chronic spontaneous urticaria (CSU)^8,9. In the US and China, remibrutinib is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines, under the brand name Rhapsido^®. Remibrutinib has shown positive topline results in chronic inducible urticaria (CIndU) across the three most prevalent subtypes in the pivotal Phase III RemIND trial. It is also being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio^10-14.

]]> Media Release Clinical Research Innovation Scientific Research Reimagine Medicine Basel, February 25, 2026 – Novartis, a leading global innovative medicines company, today announced plans to establish a new 46,000-square-foot radioligand therapy (RLT) manufacturing site in Denton, Texas. This purpose-built RLT site will be the company’s fifth in the US and first manufacturing facility in Texas, and marks further progress in the company’s $23 billion US investment.

]]> Media Release Oncology Scientific Research Drug Discovery Clinical Trials Basel, February 24, 2026 – Novartis today announced multiple US real-world studies delivering new insights across metastatic prostate cancer care. The analyses utilize data from Novartis’ PRECISION platform to evaluate Pluvicto™ (lutetium (¹⁷⁷Lu) vipivotide tetraxetan) effectiveness and sequencing as well as real‑world treatment patterns in earlier metastatic disease. These studies will be presented at the ASCO Genitourinary Cancers Symposium on February 26, 2026.

]]> Media Release Reimagine Medicine Innovation Chronic Illness Basel, February 23, 2026 – Novartis will present data from five key abstracts evaluating the highly selective oral Bruton’s tyrosine kinase inhibitor (BTKi) Rhapsido^® (remibrutinib) in chronic spontaneous urticaria (CSU) and as an investigational therapy for peanut allergy at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, PA, from February 27 to March 2, 2026. These presentations provide more evidence on the use of Rhapsido in CSU, as well as its potential in other indications and highlight Novartis commitment to addressing unmet needs in patients with immune-mediated diseases.

New analyses on the impact of Rhapsido on disease control and early symptom relief from the Phase III REMIX-1 and REMIX-2 trials in CSU will be presented. Additionally, the first presentation of Phase II FA data for remibrutinib, focusing on IgE‑mediated peanut allergy, will be featured in an oral session. Plans are in progress to begin the Phase III program in FA in 2026.

“These food allergy (FA) data further strengthen the evidence supporting remibrutinib as a novel, well-tolerated, oral option for patients with allergic and immune-mediated diseases, complementing the recent FDA approval in chronic spontaneous urticaria (CSU) and underscoring its broader therapeutic potential,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. "Our priority is advancing therapies for patients who have few alternatives and expanding the reach of innovative medicines to transform care across multiple, high-need disease areas." 

Regulatory reviews for remibrutinib for the treatment of CSU are underway in several regions, including the European Union and Japan.

In addition to FA, remibrutinib is in clinical development for chronic inducible urticaria (CIndU) and hidradenitis suppurativa (HS). FDA submission for remibrutinib in symptomatic dermographism, the most prevalent type of CIndU, was completed in Q4 2025. Additionally, positive topline results were announced for the remaining two arms of the CIndU Phase III RemIND trial. In the coming months, the full data set will be submitted to health authorities globally, and the RemIND trial findings will be presented at upcoming medical congresses.

Abstracts accepted by AAAAI include:

]]> Media Release Reimagine Medicine Innovation Chronic Illness Clinical Trials Basel, February 18, 2026 – Novartis today announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU)¹. The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria and cholinergic urticaria, achieving significantly higher complete response rates versus placebo at Week 12¹. These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need.

]]> Media Release Clinical Trials Reimagine Medicine Diseases Basel, February 13, 2026 – Novartis today announced final results from the Phase III ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy (IgAN) who were treated with Vanrafia^® (atrasentan). Vanrafia showed a difference of 2.39 ml/min/1.73m² in estimated glomerular filtration rate (eGFR) change from baseline vs. placebo (2-sided p = 0.057) at Week 136, 4 weeks after the end of study treatment¹.

Clinically meaningful results were observed with Vanrafia compared to placebo in eGFR change from baseline at the end of study treatment at Week 132, and in the prespecified exploratory group of patients additionally receiving sodium-glucose co-transporter-2 (SGLT2) inhibitors¹. At the end of treatment at Week 132, the eGFR change from baseline compared to placebo was 2.59 ml/min/1.73 m² (nominal 2- sided p = 0.039)¹.

“Progressive and complex diseases such as IgAN present an urgent need for medicines that can target the different drivers of the disease. Vanrafia can be seamlessly integrated into patients’ existing treatment plans, with a consistent safety profile,” said Ruchira Glaser, M.D., Global Head, Cardiovascular, Renal & Metabolic Development Unit, Novartis. “We are pleased with today’s Phase III ALIGN results, which add to the growing evidence of Vanrafia as a potential foundational therapy to slow kidney function decline.”

ALIGN provides the longest follow-up period in pivotal Phase III studies for IgAN³. Safety was consistent with previous findings¹.

Alongside Vanrafia, Novartis continues to advance its multi-asset IgAN portfolio, which also includes Fabhalta^® (iptacopan) and investigational compound zigakibart.

About IgAN
IgAN is a progressive autoimmune kidney disease with approximately 25 per million people newly diagnosed worldwide each year⁴. IgAN is highly debilitating as it leads to glomerular inflammation (when the small filters in the kidneys are inflamed), proteinuria (excess protein in urine), and a gradual decline in eGFR⁵. Up to 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis or kidney transplantation as part of long-term disease management^5-7.

Furthermore, people living with IgAN often face mental, social, and economic challenges^5-8. Supportive care has not addressed the underlying causes of the disease and often fails to slow disease progression, reinforcing the need for more targeted therapies for IgAN^4-9.

About Vanrafia^® (atrasentan)
Vanrafia (atrasentan) is a potent and highly selective endothelin A (ETA) receptor antagonist, which is part of the endothelin system, a key system involved in the progression of IgAN^10-13.

Vanrafia is the first and only selective ETA receptor antagonist approved for primary IgAN, a once-daily, oral treatment and can be seamlessly added to, or used alongside, existing supportive care (e.g. renin-angiotensin system (RAS) inhibitor with or without SGLT2 inhibitor) without the need for titration². Vanrafia does not require a Risk Evaluation and Mitigation Strategy (REMS) program. Because some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure, clinicians should obtain liver enzyme testing before initiating Vanrafia and during treatment when clinically indicated. Vanrafia may cause serious birth defects².

About ALIGN
The ALIGN study (NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of Vanrafia versus placebo in patients with IgAN at risk of progressive loss of kidney function^1-3. In total, 340 patients with biopsy-proven IgAN with baseline total proteinuria ≥1 g/day despite optimized RAS inhibitor treatment were randomized to receive once-daily, oral Vanrafia (0.75 mg) or placebo for approximately 132 weeks^1,11. Patients continue receiving a maximally tolerated and stable dose of a RAS inhibitor as supportive care^1,11. An additional cohort of 64 patients receiving an SGLT2 inhibitor in addition to RAS inhibitor for at least 12 weeks was also enrolled^1,11. The primary efficacy endpoint for the interim analysis (in 270 patients) was change in proteinuria, as measured by 24-hour urine protein-to-creatinine ratio (UPCR) from baseline to 36 weeks^1,3,11. The key secondary endpoint for the final analysis is the change from baseline to 136 weeks in kidney function as measured by eGFR. Other secondary efficacy endpoints as well as safety and tolerability are also assessed^1-3.

Novartis commitment to kidney diseases 
Building on a legacy of more than 40 years that began in transplant, Novartis is on a mission to empower breakthroughs and transform care in kidney health, starting with kidney conditions that have significant unmet need.

Historically, these conditions have had considerably less funding and research, leading to a treatment landscape largely focused on reactive or end-stage disease management, often with significant physical, emotional, and financial burdens. Our portfolio targets the underlying causes of disease, with an aim to protect kidney health and delay or prevent dialysis and/or transplantation. Our goal is to help patients get back to living life on their terms - whether at work, in school, or with loved ones, and by partnering with patients, advocates, clinicians and policymakers, we aim to raise awareness, accelerate diagnosis, and get patients the right care, sooner.

Disclaimer
This 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,” “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; 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 Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

]]> Media Release Clinical Research Innovation Scientific Research Reimagine Medicine Basel, February 6, 2026 – Novartis today broke ground on a new, state-of-the-art global Biomedical Research center in San Diego, California, designed to provide world-class scientific infrastructure and drug-discovery capabilities to advance the company’s pipeline for patients.

Once operational in 2029, the approximately 466,000-square-foot facility is expected to house about 1,000 Novartis employees and integrate seamlessly with Novartis global research sites including Cambridge, Massachusetts, and Basel, Switzerland, enabling integrated discovery efforts across regions.

“This new research center will strengthen our scientific leadership and accelerate the discovery of transformative medicines for patients worldwide, while deepening our connectivity with biotech, academic and technology partners across the region,” said Fiona Marshall, President of Biomedical Research at Novartis. “Designed to power future drug discovery, with a focus on genetics and human biology in key therapeutic areas such as neuroscience and oncology, it will create a single Novartis research center within one of the world’s premier life sciences ecosystems—accelerating our pipeline from discovery to patients.”

Government leaders and community partners joined Novartis employees in San Diego to mark the start of construction at the groundbreaking ceremony.

“This investment by Novartis reinforces San Diego as a place where breakthrough science happens and where innovation translates into high-quality jobs and life-changing medicines,” said Todd Gloria, San Diego Mayor. “San Diego is a global leader in life sciences because we bring together world-class talent, cutting-edge research and a collaborative ecosystem that turns discovery into impact. We’re proud to welcome this new research center and to continue building an economy rooted in innovation and results.”

The new facility builds on more than 25 years of Novartis research and development in San Diego and will support end-to-end drug discovery across core disease areas, including neuroscience, global health, oncology and age-related diseases and regenerative medicine. It will also expand the company’s capabilities in next-generation technology platforms, such as gene and cell therapies, RNA-based therapies, biologics and targeted protein degradation, and will advance novel delivery systems that open new therapeutic possibilities.

“Rooted in a strong legacy of innovation in San Diego and California, we are inspired to shape the future—driving new breakthroughs that will transform care for millions of patients worldwide,” said Thierry Diagana, California Sites Head and Global Head of Global Health, Biomedical Research, Novartis.

With advanced artificial intelligence, data and computational capabilities embedded throughout, the facility will be a key part of the global Novartis Biomedical Research network, helping share insights, scale innovation, and deliver meaningful breakthroughs for patients worldwide.

The San Diego research facility is a key pillar of the company’s USD 23 billion US investment. This includes a new flagship manufacturing hub in North Carolina; the opening of a radioligand therapy (RLT) manufacturing facility in Carlsbad, California; investments to expand existing facilities in Indiana and New Jersey; and plans to build new RLT manufacturing facilities in Florida and Texas.

Disclaimer

This 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,” “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; or regarding discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new US R&D or manufacturing capabilities. 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. Neither can there be any guarantee that the expected benefits from the plans and investments described in this press release will be achieved in the expected timeframe, or at all. 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; 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 Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

# # #

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]]> Media Release Reimagine Medicine Medical Innovations Chronic Illness Basel, January 16, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease². Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade³. Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren’s disease.

“This Breakthrough Therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjögren’s disease, who currently don't have effective treatment options for this debilitating disease,” said Angelika Jahreis, Global Head, Development, Immunology, Novartis. “We look forward to working with the agency through the regulatory review process with the hope of making ianalumab available to appropriate patients as quickly as possible.”

Building on the Fast Track designation that ianalumab was awarded in 2016, the FDA Breakthrough Therapy designation aims to expedite the development and review of therapies intended to treat serious conditions and address significant unmet needs⁴. Awarding of the Breakthrough Therapy designation is supported by positive data from multiple studies, including replicate phase III trials.

Sjögren’s disease is a serious, progressive, autoimmune condition that affects multiple organs causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma, which can carry a significant burden and impact on quality of life^5,6. Its heterogenous nature often causes it to go unrecognized or misdiagnosed⁷. Sjögren’s affects approximately 0.25% of the population, and it is estimated that 50% of people with Sjögren’s are undiagnosed^8,9. There are no approved targeted treatments available for Sjögren’s disease.

About NEPTUNUS-1 and NEPTUNUS-2  
The ianalumab Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, are global, multicenter, pivotal studies evaluating the efficacy and safety of ianalumab in patients with Sjögren’s disease^10,11. In both trials, ianalumab delivered a clinically meaningful benefit, showing improvement in disease activity and reductions in patient burden¹. Ianalumab demonstrated a favorable safety profile with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies¹.

Disclaimer
This 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,” “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; 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 Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Novartis in Immunology 
At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. 

Building on our legacy of first-in-class innovation across Rheumatology, Dermatology and Allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. From small molecules to biologics and CAR-T cell therapy, our pioneering science is focused on where we can have the greatest impact on patient outcomes. And by elevating the patient voice and building on a common purpose across the healthcare ecosystem, we are not just addressing the needs of people with autoimmune diseases – we’re reimagining medicine, together.  

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

]]> Media Release Drug Discovery Oncology Drug Design Working at Novartis Basel, January 9, 2026 – Novartis, a leading global innovative medicines company, today announced plans to build its fourth US radioligand therapy (RLT) manufacturing facility in Winter Park, Florida. The built-for-purpose, state-of-the-art facility represents another milestone in the company's $23 billion US investment announced in April 2025, further expanding manufacturing capabilities to meet growing demand for these cutting-edge cancer treatments. Novartis is scaling US manufacturing to bring innovative medicines closer to patients, so treatments are researched, made, and delivered with greater speed, reliability, and access in the communities where people live.

The new 35,000-square-foot facility in Winter Park, Florida, will come online by 2029 and will strengthen Novartis’ specialized supply chain and manufacturing capabilities across its network of RLT production facilities. The new facility will optimize the delivery of RLT medicines to patients in the southeast US and help maintain the company’s steady rate of >99% of doses administered on the planned day as the potential for this promising treatment modality continues to expand.

“Building this new facility in Florida marks an important step in fulfilling the promise of RLT for patients,” said Vas Narasimhan, CEO of Novartis. “Radioligand therapy has fundamentally changed how we approach certain cancers, and our growing US manufacturing network ensures we can continue to deliver these critical medicines with speed and reliability to patients who need them.”

RLT is a type of precision treatment that pairs a tumor-targeting molecule (ligand) with a therapeutic radioisotope, allowing radiation to be delivered directly to the tumor while minimizing harm to surrounding healthy tissue. Each RLT dose is individually prepared, and its delivery is highly time sensitive. Proximity to treatment facilities and transportation hubs is critical to ensure patients receive their therapy promptly and at the right location. RLT has the potential to transform oncology treatment and bring new options to people living with cancer.

As the sole company with two FDA-approved RLT treatments and an extensive RLT pipeline across several tumors and targets, Novartis has global expertise in this cutting-edge technology platform that is transforming cancer care. That knowledge has fueled advancements in manufacturing techniques to build capacity and consistently deliver with confidence for patients and healthcare providers.  

RLT manufacturing requires specialized talent, a key factor in determining the location for each new facility. Florida has steadily invested in higher education for life sciences and technology, helping to build the next generation of leaders critical to driving forward advanced manufacturing for platforms like RLT. With a growing skilled workforce and a regulatory and policy environment that values pharmaceutical innovation, Florida is well positioned to become a leader in pharmaceutical manufacturing. 

“Thanks to deliberate, focused, intensified investments and world class health innovation partnerships, we have led Florida to become a national and world-recognized leader for breakthroughs in cancer treatment, neurological innovations, and more,” said Florida Secretary of Commerce J. Alex Kelly. “Novartis’ investment in manufacturing cancer medicines here in Florida—where we’re already #2 nationally in both manufacturing for medicine and medical device technology—is an incredible opportunity to welcome world class innovators to our incredibly collaborative and impactful life sciences community.”

Over the next 5 years, Novartis will solidify its robust US RLT manufacturing network. The new Florida site is the fourth of five existing or planned facilities. The company is currently investing in expansions of its RLT facilities in Indiana and New Jersey. In November, Novartis announced completion of a new RLT facility in California, and it plans to build a fifth location in the US. 

Novartis and radioligand therapy (RLT)
Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation and applying it to advanced cancers, RLT is designed to deliver treatment directly to target cells anywhere in the body.  

Novartis is actively investigating the application of RLTs across cancer types and settings, with one of the deepest and most advanced pipelines in the industry, with trials in prostate cancer, breast, colon, lung, brain, pancreatic and other cancers. Novartis has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production sites around the world. 

Disclaimer 
This 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,” “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; or regarding discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new US manufacturing and R&D capabilities. 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. Neither can there be any guarantee that the expected benefits from the plans and investments described in this press release will be achieved in the expected timeframe, or at all. 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; 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 Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

]]> Media Release Reimagine Medicine Innovation Chronic Illness Basel, December 19, 2025 – Novartis, a leading global innovative medicines company, today announced it has reached an agreement with the US government that aims to lower the price of innovative medicines in the US and support continued US investment in manufacturing, and research and development.

]]> Media Release Reimagine Medicine Rare Disease Hematology Blood Disorder Basel, December 9, 2025 – Novartis today announced positive results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids^1-3. Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, based on the primary endpoint of time to treatment failure (TTF), which assesses how long patients maintain safe platelet levels during and after the treatment period^1,2. The median time to treatment failure for patients receiving ianalumab plus eltrombopag was 2.8 times longer than those on placebo plus eltrombopag (13.0 months vs. 4.7 months)^1,2.

Detailed data will be presented during the Late-Breaking Abstract Session at the 67^th American Society of Hematology Annual Meeting & Exposition (ASH) and simultaneously published in The New England Journal of Medicine^1,2.

“Treatments for ITP have historically focused on raising platelet counts, often requiring chronic therapy to control ITP. This means many patients remain on treatment long-term, facing persistent disease burden and symptoms like fatigue,” said Hanny Al-Samkari, M.D., Peggy S. Blitz Endowed Chair in Hematology/Oncology, Mass General Brigham, and Associate Professor of Medicine, Harvard Medical School. “The VAYHIT2 trial results are encouraging, as they demonstrated improved disease control even while patients spend time off treatment, pointing toward possible progress for people living with ITP.”

Patients receiving ianalumab (9 mg/kg) plus eltrombopag also achieved a significantly higher rate of sustained platelet count improvement at six months versus placebo plus eltrombopag (62% vs. 39%), meeting the key secondary endpoint^1,2. Fatigue improvement, as measured by PROMIS Fatigue, showed a mean reduction of 7.7 points with ianalumab plus eltrombopag versus 3.6 points with placebo plus eltrombopag^1,2.

“B cells drive the autoimmune response that leads to platelet destruction and increased bleeding risk in ITP. The novel dual mechanism of action of ianalumab aims to deplete B cells while blocking their survival signals,” said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. “Guided by our decades-long experience advancing ITP care, the VAYHIT2 findings underscore the potential of ianalumab to deliver durable control with a short course of four once-monthly doses, offering patients the possibility of achieving disease stability without ongoing treatment.”

Two doses of ianalumab were assessed in VAYHIT2 with ianalumab 9 mg/kg demonstrating statistically significant improvements across both the primary and key secondary endpoints, and ianalumab 3 mg/kg demonstrating statistically significant improvements in the primary endpoint and numerical improvements in the key secondary endpoint^1-3.

]]> Media Release oncology drug development innovation scientific discoveries Basel, December 9, 2025 – Novartis today announced results showing that one in four patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) remained progression-free for four or more years following treatment with Kisqali® (ribociclib) plus endocrine therapy (ET)¹. Results were from a pooled, post-hoc exploratory analysis of first-line patients in the MONALEESA trials and will be presented at the 2025 San Antonio Breast Cancer Symposium® (SABCS) on December 11, 2025.

]]> Media Release Drug Discovery Clinical Trials Data Science Oncology Basel, November 25, 2025 – Novartis will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium^® (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract.

“For decades, Novartis has redefined the future of hematology and oncology, and we’re building on that foundation with compelling new data presented at ASH and SABCS,” said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. “These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients.”

Key highlights of data accepted by ASH include:

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]]> Media Release Cancer Drug Development Medical Innovations Cell and Gene Therapy Basel, November 19, 2025 – Novartis, a leading global innovative medicines company, today announced plans to expand its operations in North Carolina, creating a new flagship manufacturing hub with end-to-end manufacturing capabilities. The strategic investment is a major step to ensure all key Novartis medicines for US patients are manufactured in the US and delivered to patients across the country at scale.

This announcement is part of Novartis’ $23 billion investment in US-based infrastructure over the next five years, designed to increase manufacturing capacity and enable 100% of the company's key medicines to be produced end-to-end in the US.

As part of this flagship hub in North Carolina, Novartis will:

]]> Media Release Malaria Reimagine Medicine Basel, November 12, 2025 – Novartis today announced positive results from KALUMA, a Phase III study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum). The novel non-artemisinin antimalarial, which was developed with Medicines for Malaria Venture (MMV), met the study’s primary endpoint of non-inferiority to the current standard of care. The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94.0% with standard of care. This equates to cure rates of 99.2% and 96.7% respectively based on conventional per protocol analysis.

The trial studied 1,688 adults and children across 34 sites in 12 African countries, with GanLum given as a sachet of granules once a day for three days. Additional analysis indicated the treatment was highly effective against mutant malaria parasites associated with partial drug resistance. The treatment was also found to have a rapid response against mature gametocytes, the sexual stage of the parasite’s lifecycle responsible for onward transmission. 

The findings come amid urgent calls to tackle the growing threat of antimalarial drug resistance in Africa.¹ Data were presented at the American Society of Tropical Medicine and Hygiene annual meeting 2025.²

“GanLum could represent the biggest advance in malaria treatment for decades, with high efficacy against multiple forms of the parasite as well as the ability to kill mutant strains that are showing signs of resistance to current medicines,” said Dr Abdoulaye Djimdé, Professor of Parasitology and Mycology at the University of Science, Techniques and Technologies of Bamako, Mali. “Drug resistance is a growing threat to Africa, so new treatment options can’t come a moment too soon.”

GanLum is a combination of two compounds, attacking the malaria parasite on multiple fronts: ganaplacide, a novel compound with an entirely new mechanism of action, and a new once-daily formulation of existing antimalarial lumefantrine, a longer-acting treatment. 

Ganaplacide is understood to work by disrupting the parasite’s internal protein transport systems, which are essential for its survival inside red blood cells.³ It belongs to a class of compounds called imidazolopiperazines, first identified as potential antimalarials after a groundbreaking screen of 2.3 million molecules to find drug candidates at Novartis labs in San Diego, California.

“Drug-resistant parasites threaten the efficacy of medicines that have helped to control malaria for decades,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Together with our partners, we’ve gone further to develop a new class of antimalarial with an entirely new mechanism of action, which has the potential to both treat the disease and block transmission. We look forward to working with health authorities to bring this innovation to patients as soon as possible, helping close a critical gap in malaria care for those who need it most.”

Novartis plans to seek regulatory approvals from health authorities for GanLum as soon as possible. The combination therapy was granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration in 2022. If authorized by regulators, GanLum would represent the first major innovation in malaria treatment since artemisinin-based combination therapies, the current gold standard treatments, were introduced more than 25 years ago.⁴

The treatment was developed by Novartis with the scientific and financial support of MMV, and within the framework of the WANECAM2 consortium, which is funded by the European & Developing Countries Clinical Trials Partnership Programme supported by the European Union, with co-funding from the German Aerospace Center and the UK Department of Health and Social Care.

“Antimalarial drug resistance is a ticking clock—without action today, lives will be lost,” said Dr Martin Fitchet, CEO of MMV. “GanLum’s Phase III results are a key step towards a new tool to help stay ahead of resistance. Working with Novartis and our partners, we’re committed to turning this promise into impact.”

About the KALUMA study
The KALUMA (NCT05842954) study was a Phase III randomized, open-label, multicenter study to compare efficacy, safety and tolerability of GanLum with Coartem® (artemether-lumefantrine), the standard of care, in the treatment of acute, uncomplicated malaria due to Plasmodium falciparum in adults and children. The trial studied 1,668 adults and children ≥ 10kg with acute, uncomplicated malaria due to Plasmodium falciparum, with or without mixed plasmodium infection, at 34 trial sites across 12 countries in sub-Saharan Africa. Patients treated with GanLum were given a once-daily dose for three days, as a sachet of granules. The primary analysis was conducted using an ‘estimand’ approach, a conservative approach required to support regulatory submissions, which considers patients who discontinue the study or for whom PCR data is missing at the time of the primary analysis to have failed the treatment. A conventional ‘per protocol’ approach, which excludes these patients from the analysis, is the standard methodology used in clinical trials for antimalarials, and more easily allows for comparison to historical trials and other antimalarial drugs. The principal stratum estimand consisted of patients who took a complete course of study treatment (at least 80% of study medication) and took non-study treatment with antimalarial activity prior to day 29 only in case of recrudescence. Results found:

]]> Media Release Innovation Working at Novartis Oncology Drug Discovery Basel, November 10, 2025 – Novartis, a leading global innovative medicines company, today announced the opening of a new 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California. This state-of-the-art site represents a key milestone in the company’s previously announced $23 billion investment in US infrastructure over the next five years.

]]> Media Release Clinical Trials Drug Development Rare Diseases Reimagine Medicine Basel, November 4, 2025 – Novartis will present new data from 33 abstracts across its Cardiovascular, Renal, and Metabolic (CRM) disease portfolio at the upcoming American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas and American Heart Association's (AHA) Scientific Sessions 2025 in New Orleans, Louisiana, advancing scientific insight into these critical disease areas.

“Novartis will present a broad range of data at ASN and AHA demonstrating innovation and commitment to advancing therapies that address root causes of heart and kidney conditions,” said Ruchira Glaser, M.D., Global Head, Cardiovascular, Renal and Metabolic Development Unit, Novartis. "Studies on both our approved and investigational therapies in these closely connected therapeutic areas reflect our longstanding dedication to deliver meaningful solutions for patients living with some of the rarest to most prevalent CRM diseases worldwide.”

Key highlights of data accepted by ASN include:

]]> Media Release Reimagine Medicine Clinical Trials Medical Innovations Chronic Illness Basel, October 29, 2025 – Novartis today presented new ianalumab data in Sjögren’s disease, the second most prevalent rheumatic autoimmune disease², at a late-breaker presentation during the American College of Rheumatology Convergence congress¹.

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