Novartis today announced that it has entered into a definitive agreement to acquire Tourmaline Bio, a biotechnology company focused on advancing transformative therapies for cardiovascular and cardiometabolic disease. The proposed transaction is expected to further strengthen the Novartis cardiovascular franchise by adding pacibekitug, an investigational therapy being developed for patients with atherosclerotic cardiovascular disease (ASCVD). The addition of pacibekitug would complement Novartis’ existing portfolio and pipeline, underscoring the Company’s commitment to reimagining cardiovascular care through science-driven innovation that addresses persistent residual risk.

Strategic rationale

• Expands the breadth of the Novartis cardiovascular pipeline with an investigational therapy designed to address key drivers of residual cardiovascular risk in ASCVD.
• Enhances the Company’s long-term strategy to deliver precision, durable, and convenient solutions for secondary prevention and high-risk primary prevention populations.
• Builds on the Company’s development and commercialization capabilities in cardiometabolic diseases, including late-stage outcomes programs and global market access expertise.
• Aligns with Novartis’ capital allocation priorities by investing in assets with clear scientific rationale, compelling clinical potential, and opportunities for lifecycle expansion.

About ASCVD and the unmet need

ASCVD remains the leading cause of morbidity and mortality worldwide. Despite widespread adoption of lipid-lowering therapies and guideline-directed medical therapy, many patients continue to face substantial residual risk of recurrent cardiovascular events. This residual risk may be driven by a confluence of factors, including atherogenic lipoproteins, inflammation, and other metabolic contributors. Innovative therapies that target complementary pathways have the potential to meaningfully reduce this burden by achieving deeper and more durable risk reduction.

About pacibekitug

Pacibekitug is an investigational therapeutic candidate being developed for the treatment of ASCVD. It is intended to address clinically relevant drivers of atherosclerosis in patients at high risk of cardiovascular events. The development strategy for pacibekitug aims to evaluate efficacy, safety, and durability of effect in populations with established ASCVD and those at heightened risk due to persistent, modifiable factors despite standard-of-care therapy.

Pacibekitug has not been approved for use by any regulatory authority. Its safety and efficacy have not been established. Ongoing and planned clinical trials are designed to characterize pacibekitug’s profile, including its effect on biomarkers associated with atherosclerosis and hard cardiovascular outcomes where appropriate.

Complementing the Novartis cardiovascular portfolio

The proposed acquisition is expected to complement Novartis’ cardiovascular efforts across lipid management, vascular inflammation, and cardiometabolic risk reduction. By adding pacibekitug, Novartis intends to broaden the range of potential interventions available to patients and clinicians, spanning both foundational and emerging mechanisms that collectively aim to reduce the incidence of myocardial infarction, stroke, and cardiovascular death.

Novartis plans to leverage its global development infrastructure, outcomes-trial expertise, and manufacturing and supply capabilities to accelerate the clinical development of pacibekitug and, if approved, enable broad and equitable patient access.

Clinical development and next steps

Following the close of the transaction, Novartis intends to collaborate with key stakeholders, investigators, and regulatory agencies to advance a focused, data-driven development program for pacibekitug. Planned activities include:

• Execution of studies designed to confirm the candidate’s pharmacology and clinical impact in at-risk ASCVD populations.
• Exploration of dosing regimens intended to optimize efficacy, safety, and patient convenience.
• Potential evaluation of pacibekitug in combination with guideline-directed therapies to address multiple, complementary risk pathways.
• Integration of patient-centric endpoints and real-world evidence to inform access and adoption, if approved.

Details regarding the anticipated timeline for regulatory interactions, study initiations, and readouts will be communicated following closing and alignment with relevant authorities.

Transaction terms and closing

The proposed acquisition of Tourmaline Bio by Novartis is subject to customary closing conditions, including regulatory approvals and the satisfaction of other conditions specified in the definitive agreement. Until the transaction closes, Novartis and Tourmaline Bio will continue to operate as independent companies.

Commitment to patients and health systems

Novartis is committed to improving cardiovascular outcomes globally by advancing breakthrough science and addressing barriers to access. If approved, pacibekitug could represent an additional option for patients living with ASCVD, with the potential to reduce recurrent events and the overall burden on patients, caregivers, and health systems.

About Novartis

Novartis is a focused medicines company. With a strategy anchored in innovative platforms and therapeutic areas of high unmet need, Novartis leverages cutting-edge science to deliver medicines that improve and extend people’s lives. The Company has a longstanding heritage in cardiovascular and cardiometabolic disease, supported by a global development footprint and deep real-world implementation expertise. For more information, please visit the Novartis website and follow Novartis on social media.

About Tourmaline Bio

Tourmaline Bio is a biotechnology company dedicated to developing transformative therapies for patients with serious cardiometabolic and cardiovascular conditions. The company’s pipeline focuses on addressing key drivers of disease progression and residual risk, with an emphasis on rigorous clinical development and patient-centric innovation.

Forward-looking statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including, but not limited to, statements regarding: the proposed acquisition of Tourmaline Bio; the anticipated benefits of the transaction; the potential therapeutic impact, safety, efficacy, and clinical development plans for pacibekitug; expected timelines for regulatory filings, clinical studies, and potential approvals; and Novartis’ strategy, plans, and prospects in cardiovascular disease. Forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described. These risks and uncertainties include, among others, the possibility that the proposed transaction is delayed or does not close; the ability to obtain necessary regulatory approvals; the outcomes of ongoing or future clinical trials; uncertainties inherent in research and development; regulatory actions; manufacturing and supply risks; competitive developments; and other factors described in Novartis’ and Tourmaline Bio’s filings with applicable securities regulators. Novartis undertakes no obligation to update forward-looking statements except as required by law.