Novartis announced that it has agreed to acquire a next-generation PI3Kα inhibitor program from Synnovation Therapeutics in a deal valued at $2 billion upfront, with up to $1 billion in additional milestone payments. The transaction is expected to close in the first half of 2026, subject to regulatory approvals and customary closing conditions.
The acquisition centers on SNV4818, an oral, pan-mutant-selective PI3Kα inhibitor currently in Phase 1/2 clinical trials for hormone receptor-positive, HER2-negative breast cancer and other advanced solid tumors. The drug is designed to selectively target mutated PI3Kα enzymes in cancer cells while sparing the normal, or wild-type, version of the enzyme, a strategy aimed at improving tolerability and reducing side effects.
Approximately 40 percent of patients with HR+/HER2- breast cancer have PIK3CA mutations, which are associated with poorer disease outcomes. Existing PI3Kα inhibitors target both mutant and wild-type enzymes, often leading to tolerability challenges that can limit treatment adherence. SNV4818’s selective approach is intended to enable more consistent dosing and improve its compatibility with combination therapies, including endocrine treatments and CDK inhibitors.
Preclinical data have shown strong activity against common PIK3CA mutations and a high degree of selectivity over the normal enzyme. Clinical evaluation of the therapy is ongoing, with the program aligned to Novartis’ broader oncology strategy focused on precision medicine and combination regimens.
Under the agreement, Novartis will acquire Pikavation Therapeutics, a wholly owned subsidiary of Synnovation that holds a portfolio of PI3Kα inhibitor programs, including SNV4818. The deal supports Novartis’ efforts to expand its pipeline in breast cancer and other solid tumors, reinforcing its focus on targeted therapies that improve patient outcomes while minimizing adverse effects.
Novartis stated that the acquisition fits within its long-term oncology strategy, which emphasizes developing differentiated medicines across solid tumors, hematology, and radioligand therapies. The company continues to invest in therapies designed to address unmet medical needs through advanced science and patient-centered research.
KEY QUOTE:
“While mutated PI3Kα is a well established driver in HR+/HER2 breast cancer, there remains a challenge in achieving effective pathway inhibition with a tolerable therapeutic profile. SNV4818 applies new mutant selective chemistry to more precisely target tumor biology while sparing normal cells. This approach has the potential to translate proven biology into improved tolerability and more durable benefit for patients through precision medicine.”
Shreeram Aradhye, President of Development at Novartis
