Novartis has revealed its intention to acquire San Diego-based Regulus Therapeutics, a publicly traded clinical-stage biopharmaceutical company, in a deal valued at up to $1.7 billion. The agreement, which has received unanimous approval from both companies’ boards, includes an upfront cash payment of $800 million and a potential $900 million contingent on the achievement of a future regulatory milestone.
This acquisition aligns with Novartis’ therapeutic focus on renal disease and leverages its expertise in this area. Regulus’ flagship asset, farabursen, is a next-generation oligonucleotide therapy targeting microRNA-17 (miR-17), aimed at treating autosomal dominant polycystic kidney disease (ADPKD) — the most common inherited cause of renal failure worldwide.
“Farabursen represents a potential first-in-class treatment for ADPKD, with early clinical data indicating it could offer improved efficacy, tolerability, and safety compared to current therapies,” said Dr. Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis. “We are excited to build on the foundational work done by the Regulus team and explore farabursen’s full potential in improving outcomes for patients.”
Promising Data Fuels Confidence in Farabursen’s Future
Regulus Therapeutics has recently completed a successful Phase 1b clinical trial of farabursen, demonstrating encouraging safety and efficacy signals. The drug, designed to inhibit miR-17 with preferential kidney exposure, aims to reduce cyst growth and kidney size in ADPKD patients, thereby slowing disease progression.
Data from the Phase 1b study indicated a consistent impact on key biomarkers such as urinary polycystin (PC) and height-adjusted total kidney volume (htTKV), both of which are used to measure disease progression in ADPKD. These positive results have bolstered confidence in the drug’s potential as a breakthrough treatment option.
Farabursen’s unique mechanism and targeted delivery may distinguish it from current standard-of-care therapies, which offer limited options for patients battling this progressive and often debilitating condition.
Deal Structure and Timeline
Under the agreed terms, Novartis, through an indirect wholly owned subsidiary, will initiate a tender offer to acquire all outstanding shares of Regulus common stock. Shareholders will receive $7 per share in cash upon closing, along with a contingent value right (CVR) worth up to an additional $7 per share, dependent on future regulatory approval milestones.
Once the tender offer is completed, Novartis will merge the acquiring subsidiary with Regulus, making the company a wholly owned subsidiary of Novartis. The deal is expected to close in the second half of 2025, pending customary closing conditions, regulatory approvals, and a majority tender of Regulus Therapeutics shares.
Until the transaction is finalized, both companies will continue to operate independently. The acquisition underscores Novartis’ commitment to innovation in renal therapies and highlights the growing interest in RNA-based treatments as a frontier in disease management.
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