Novartis has committed up to $3 billion—two-thirds of that upfront—toward acquiring Pikavation Therapeutics, a subsidiary of Synnovation Therapeutics that specializes in developing PI3Kα inhibitor programs designed to treat forms of cancer.
Pikavation’s programs are led by SNV4818, a pan-mutant selective PI3Kα (phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) inhibitor currently in early-stage clinical trials for the treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and other solid tumors.
Novartis reasons that by targeting PI3Kα, it can reduce the approximately 40% of HR+/HER2- breast cancer patients who potentially face worse disease prognosis due to the presence of PIK3CA mutations in their tumors.
SNV4818 is designed to target the mutated PI3Kα enzyme found in cancer cells while sparing wild-type PI3Kα in healthy cells, unlike currently available PI3Kα inhibitors that block both mutant and wild-type PI3Kα, leading to tolerability challenges for patients.
By focusing on the mutated form in tumors, Novartis said, SNV4818 aims to reduce unwanted side effects, support more consistent dosing, and make it easier to combine with hormonal therapy and other treatments earlier in care. Preclinical studies have shown strong activity against common PIK3CA mutations and clear selectivity over the normal enzyme, the company added.
SNV4818 is now being evaluated in a Phase I/II open-label dose escalation and expansion study (NCT06736704) as a monotherapy and in combination with fulvestrant and palbociclib, a combination therapy that is standard of care for HR+/HER2- breast cancer. Fulvestrant was launched to market by AtsraZeneca as Faslodex® and is now sold as a generic drug by numerous companies, while palbociclib is marketed by Pfizer as Ibrance®.
The trial’s estimated primary completion date is April 2027.
“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,” Shreeram Aradhye, MD, Novartis’ president of development, said in a company statement. “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.”
Added Synnovation CEO Wenqing Yao, PhD, in a separate statement: “We believe Novartis’s global capabilities and commitment to patients with cancer will accelerate the development of SNV4818 for patients with PI3Kα mutation–driven solid tumors beyond what Synnovation could achieve alone.”
Yao added that Synnovation will continue advancing other programs in its R&D pipeline, including the selective PARP1 inhibitor SNV1521 and other oncology and immunology programs. Synnovation will continue operating as an independent entity and retain ownership of its other R&D subsidiaries.
Novartis has agreed to solely oversee future development and commercialization of SNV4818 and other PI3Kα inhibitor programs. In return, Novartis agreed to pay Synnovation $2 billion cash upfront and up to $1 billion in payments tied to achieving development, regulatory, and commercial milestones.
The transaction is expected to be finalized in the first half of 2026, subject to completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
Novartis investors sold enough shares to send the pharma giant’s stock on the SIX Swiss exchange dipping 1% Friday, from CHF 116.88 ($148.31) to CHF 115.60 ($146.69). Novartis’ U.S. stock, traded on the New York Stock Exchange, slid 1.5% Friday from $148.19 to $146.03.
Privately held Synnovation is based in Wilmington, DE.
