Novartis to Acquire Regulus Therapeutics

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After announcing successful trial results for its lead mRNA treatment earlier this year, Regulus Therapeutics agreed to be acquired by Novartis.¹ This will add the potential kidney disease treatment to Novartis’ already expansive pipeline of treatments for renal disease.

According to a press release from Novartis, the boards of both companies have agreed to the deal. Through a wholly owned subsidiary, Novartis will purchase all outstanding shares of Regulus’ stock at $7-a-share. Future payments upon the completion of certain regulatory milestones have also been worked into the deal.

The acquisition is expected to close in the second half of 2025.

In a press release, Novartis’ president of development and chief medical officer Shreeram Aradhye said, “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. ADPKD is the most common genetic cause of renal failure worldwide1. 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 Regulus’ lead therapeutic and completed Phase1b trials earlier this year. The mRNA treatment targets miR-17 and is designed to be a treatment for autosomal dominant polycystic kidney disease. The therapeutic is designed to reduce the growth of cysts and kidney size while also delaying the progression of the disease.

This is the latest acquisition announcement by Novartis. In February, the company announced that Anthos Therapeutics agreed to be acquired by the larger company.² Anthos is developing a treatment to prevent stroke and systemic embolism in patients with atrial fibrillation. FDA granted the treatment Fast Track Designation in July 2022.

In a press release issued at the time, Aradhye said, “We are excited to join forces to advance the development of abelacimab, a potential first-in-class treatment and safer approach for stroke prevention in atrial fibrillation as well as cancer-associated thrombosis. Welcoming Anthos Therapeutics strengthens our focus in the cardiovascular space and complements our portfolio of life-changing treatments, comprehensive clinical programs, and strategic collaborations that help thousands of patients with heart disease around the world.”

In the same press release, Novartis’ global head of cardiovascular, renal, and metabolism development unit David Soergel, MD, said, “Abelacimab is a potential first-in-class medicine, which promises to be an effective and safer approach to preventing thrombosis and stroke than the current standards of care. We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program. Now is the right time to bring abelacimab back into the Novartis CRM pipeline.”

Novartis will make an upfront payment of $925 million, with potential additional payments depending on certain regulatory and sales milestones totaling up to $925 billion. At the time, Novartis reported that the transaction was expected to close in the first half of 2025.

Sources

1. Novartis to acquire Regulus Therapeutics and farabursen, an investigational microRNA inhibitor to treat ADPKD, the most common genetic cause of renal failure. Novartis. April 30, 2025. https://www.novartis.com/news/media-releases/novartis-acquire-regulus-therapeutics-and-farabursen-investigational-microrna-inhibitor-treat-adpkd-most-common-genetic-cause-renal-failure
2. Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront. Novartis. February 11, 2025. Accessed May 1, 2025. https://www.novartis.com/news/media-releases/novartis-bolsters-late-stage-cardiovascular-pipeline-agreement-acquire-anthos-therapeutics-usd-925-million-upfront