Novartis

NVS

Market cap $322B

Adds Avidity's differentiated muscle-directed Antibody Oligonucleotide Conjugates (AOC) platform and three late-stage programs to industry-leading neuromuscular pipeline Potentially unlocks multi-billion-dollar opportunities with planned product launches before 2030 Strengthens late-stage pipeline to further support 2025-2030 net sales CAGR of 5-6% cc and mid to long term growth outlook 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.

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 swelling5-7. 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 portfolio10 - 14.

Novartis and Genentech are suing a U.S. company and a Canadian pharmacy over the importation of a Canadian version of their allergy medicine. The importation of the drug, which has strict shipping and temperature controls, potentially puts patients at risk, the suit said.

Novartis said on Wednesday it intends to build a radioligand therapy manufacturing site in Texas, expanding its U.S. footprint with what will be its first such facility in the state and fifth nationwide.

Novartis' business is resilient, as evidenced by its ability to grow sales despite a major patent cliff. The Swiss healthcare giant's income program is another great attraction for long-term investors.

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:

Novartis is a large drugmaker with a wide-ranging portfolio. Like all drugmakers, it faces the challenge of patent expirations.

U.S. President Donald Trump said he met Vas Narasimhan, the chief executive officer of Swiss drugmaker Novartis , at the White House on Wednesday.

Swiss pharmaceutical firm Novartis said on Friday that it would sell its entire 70.68% stake in its listed Indian unit to a consortium of WaveRise Investments, ChrysCapital and Two Infinity Partners.

Unnatural Products said on Wednesday it has signed a licensing agreement with Novartis to develop macrocyclic peptide-based therapies for a cardiovascular program.