Novartis Strikes Up To $3B Deal To Acquire Next-Gen PI3Kα Breast Cancer Therapy, Expands Oncology Pipeline With Acquisition

Novartis has signed an agreement with Synnovation Therapeutics, LLC to acquire SNV4818, a pan-mutant-selective PI3Kα inhibitor being developed as a next-generation therapy for HR-positive/HER2-negative breast cancer and potentially other solid tumours. The move strengthens Novartis’ oncology pipeline and aligns with its focus on advancing targeted breast cancer treatments.

SNV4818 is an oral therapy currently under evaluation in a Phase I/II clinical study for breast cancer and other advanced solid tumours. Mutations in the PI3Kα pathway are well established in HR+/HER2- breast cancer, with PIK3CA mutations present in roughly 40% of patients and often linked to poorer prognosis. The candidate is expected to integrate well with existing treatment strategies, including CDK inhibitors and endocrine therapies, within combination regimens.

“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,” said Shreeram Aradhye, M.D., President of Development at Novartis. “SNV4818 applies new mutant‑selective chemistry to more precisely target tumour 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.”

Unlike currently available PI3Kα inhibitors, which often cause tolerability limitations by blocking both mutant and wild-type enzymes, SNV4818 is engineered to selectively target mutant PI3Kα in tumour cells while sparing the wild-type enzyme in healthy tissue. This selective approach aims to minimise side effects, enable more consistent dosing, and support earlier and more flexible combination use with hormonal and other cancer therapies. Preclinical research has demonstrated strong activity against common PIK3CA mutations and high selectivity, with clinical testing ongoing.

Under the deal terms, Novartis will pay $2 billion upfront and up to $1 billion in additional milestone payments to acquire Pikavation Therapeutics, Inc., a wholly owned subsidiary of Synnovation that holds a portfolio of pan-mutant selective PI3Kα inhibitor programs, including SNV4818. The transaction is expected to close in the first half of 2026, subject to customary conditions and regulatory approvals.