Novartis and Regulus Therapeutics
Type: Acquisition agreement
Buyer: Novartis
Seller: Regulus Therapeutics
Focus: Farabursen
Per share value: USD 7 per share in cash
Upfront payment: USD 0.8 billion
Payment upon the achievement of a future regulatory milestone: USD 0.9 billion
Financial impact: Farabursen could potentially generate substantial revenue if approved for autosomal dominant polycystic kidney disease (ADPKD)
Novartis has announced a definitive agreement to acquire Regulus Therapeutics, a publicly traded, clinical-stage biopharmaceutical company based in San Diego. Regulus specializes in the development of microRNA-targeted therapies. Its lead candidate, farabursen, is a next-generation, first-in-class oligonucleotide designed to target miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). This acquisition aligns with Novartis' strategic focus on renal diseases and builds on its expertise in the area. Under the agreement—unanimously approved by both companies’ Boards of Directors—Novartis, through an indirect wholly owned subsidiary, will launch a tender offer to acquire all outstanding shares of Regulus common stock.
Shareholders of Regulus will receive $7 per share in cash at closing, plus a contingent value right (CVR) worth up to an additional $7 per share in cash, subject to the achievement of a specific regulatory milestone. The transaction involves an upfront payment of USD 0.8 billion, with the possibility of an additional USD 0.9 billion contingent on the achievement of a future regulatory milestone.
Following the successful completion of the tender offer, the acquiring subsidiary will merge with Regulus, making Regulus an indirect, wholly owned subsidiary of Novartis.
The deal is expected to close in the second half of 2025, pending customary closing conditions, including the tender of a majority of Regulus' outstanding shares and regulatory approvals. Until then, Novartis and Regulus will continue to operate independently.
Overview of Farabursen Treatment
Farabursen (RGLS 8429) is an investigational microRNA inhibitor developed by Regulus Therapeutics for the treatment of autosomal dominant polycystic kidney disease (ADPKD). RGLS 8429 targets miR-17, leveraging the company’s microRNA development platform to preferentially concentrate in the kidneys. The treatment aims to reduce cyst growth and kidney size, while slowing the progression of disease severity in ADPKD. Clinical development of RGLS 8429 is currently ongoing in the United States.
Market Impact of This Partnership
Farabursen (RGLS 8429) is an investigational microRNA inhibitor developed by Regulus Therapeutics for the treatment of autosomal dominant polycystic kidney disease (ADPKD). RGLS 8429 targets miR-17, leveraging the company’s microRNA development platform to preferentially concentrate in the kidneys. The treatment aims to reduce cyst growth and kidney size, while slowing the progression of disease severity in ADPKD. Clinical development of RGLS 8429 is currently ongoing in the United States.
“With the acquisition of Regulus Therapeutics and its lead candidate farabursen, Novartis is expanding into microRNA therapies to strengthen its renal disease pipeline and advance innovative treatments for ADPKD”