April 30, 2025 – Basel — Novartis has announced plans to acquire Regulus Therapeutics, a San Diego-based biopharmaceutical company specializing in microRNA-targeted therapies, in a move that strengthens its leadership in renal disease innovation. The acquisition centers on Regulus’ lead investigational therapy, farabursen—a next-generation oligonucleotide targeting miR-17, aimed at treating autosomal dominant polycystic kidney disease (ADPKD), the most common inherited cause of kidney failure.
With this acquisition, Novartis continues to sharpen its focus on therapies for high-need areas, particularly in nephrology, where patients often face limited options. The deal includes an upfront payment of $800 million, with a potential additional milestone-based payout of $900 million, pending regulatory achievements. The transaction is expected to close in the second half of 2025, subject to customary approvals and conditions.
“With limited treatment options currently available for patients suffering from ADPKD, farabursen represents a potential first-in-class medicine with a profile that may provide enhanced efficacy, tolerability and safety versus standard of care,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. “The team at Regulus has done meaningful foundational work with farabursen, and we look forward to investigating its potential further as we aim to bring a better treatment option to patients in need.”
Farabursen is designed to selectively inhibit miR-17 and preferentially target the kidneys, aiming to slow cyst growth, reduce kidney size, and delay disease progression. Results from a recently completed Phase 1b trial showed promise across key metrics, including reduction in height-adjusted total kidney volume (htTKV) and favorable signals on urinary polycystin—a key biomarker.
The agreement was unanimously approved by both companies’ Boards of Directors. Under the deal, Novartis will launch a tender offer to purchase all outstanding shares of Regulus common stock for $7 per share in cash. In addition, shareholders will receive a contingent value right (CVR) worth up to $7 per share, payable upon achieving a regulatory milestone.
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Once the transaction closes, Regulus will become a wholly owned subsidiary of Novartis. Until then, both companies will continue to operate independently.
This acquisition marks another bold step for Novartis, which is rapidly expanding its footprint in kidney health. In just the past nine months, the company has secured three FDA approvals in nephrology, including Vanrafia® for IgA nephropathy in April 2025, and Fabhalta® for both C3 glomerulopathy and IgAN in 2024 and 2025 respectively.
