Novartis Advances Precision Medicine Strategy with Agreement to Acquire SNV4818 for HR Positive HER2 Negative Breast Cancer

Novartis Advances Precision Medicine Strategy with Agreement to Acquire SNV4818 for HR Positive HER2 Negative Breast Cancer

(IN BRIEF) Novartis has agreed to acquire SNV4818 from Synnovation Therapeutics, a next-generation PI3Kα inhibitor designed to selectively target mutations in HR+/HER2- breast cancer. The therapy, currently in Phase 1/2 clinical trials, aims to improve treatment tolerability by focusing on mutated enzymes while sparing healthy cells. The acquisition addresses a significant patient population, as around 40% of individuals with this type of breast cancer carry PIK3CA mutations. The deal includes an upfront payment of USD 2 billion and up to USD 1 billion in milestone payments, with completion expected in the first half of 2026. The move supports Novartis’ strategy to expand its oncology pipeline with precision medicines.

(PRESS RELEASE) BASEL, 20-Mar-2026 — /EuropaWire/ — Novartis has entered into an agreement with Synnovation Therapeutics, LLC to acquire SNV4818, a next-generation investigational therapy targeting hormone receptor positive, human epidermal growth factor receptor two-negative (HR+/HER2-) breast cancer. The acquisition forms part of Novartis’ broader oncology strategy to expand its pipeline with precision medicines addressing well-defined patient populations.

SNV4818 is an oral pan-mutant selective PI3Kα inhibitor currently being evaluated in a Phase 1/2 clinical study for breast cancer and other advanced solid tumors. The therapy is designed to selectively inhibit mutated forms of the PI3Kα enzyme, which play a key role in tumor development, while sparing the normal, or wild-type, enzyme found in healthy cells.

Approximately 40% of patients with HR+/HER2- breast cancer carry PIK3CA mutations, which are associated with more challenging disease progression. By focusing specifically on these mutations, SNV4818 aims to deliver a more targeted treatment approach for a patient group with significant unmet medical need.

Unlike currently available PI3Kα inhibitors that affect both mutated and normal forms of the enzyme, often leading to tolerability issues, SNV4818 is designed to improve the therapeutic profile by reducing off-target effects. This selective mechanism may allow for more consistent dosing and better integration into combination treatment regimens, including hormonal therapies and CDK inhibitors.

Preclinical data has demonstrated strong activity against common PIK3CA mutations along with clear selectivity compared to the normal enzyme, while clinical evaluation is ongoing to further assess its safety and efficacy in patients.

The acquisition will be carried out through the purchase of Pikavation Therapeutics, Inc., a wholly owned subsidiary of Synnovation Therapeutics that holds a portfolio of pan-mutant selective PI3Kα inhibitor programmes, including SNV4818. Under the terms of the agreement, Novartis will provide an upfront payment of USD 2 billion, with the potential for up to USD 1 billion in additional milestone payments.

The transaction is expected to be completed in the first half of 2026, subject to customary closing conditions, including regulatory approvals. The addition of SNV4818 is intended to complement Novartis’ existing oncology portfolio and strengthen its focus on precision therapies that aim to improve outcomes and quality of life for patients with breast cancer and other solid tumors.

Novartis in oncology
The Novartis oncology strategy focuses on people living with cancer and those who care for them, from loved ones to clinical care teams, including their providers. For the past 30+ years, the aim has been to extend and improve lives by discovering differentiated, innovative and practice-changing medicines for patients.

As Novartis reimagines medicine, it collaborates with a wide range of patient advocacy groups and supports education, early cancer screening and diagnosis. With a broad research and development portfolio across solid tumors, hematology and radioligand therapy (RLT), Novartis is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need.

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 SNV4818; 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 Pikavation Therapeutics, 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 SNV4818 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 SNV4818 will be commercially successful in the future. In particular, our expectations regarding SNV4818 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.

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SOURCE: Novartis