Anthos Therapeutics, Inc.

Novartis has announced that it will be acquiring Regulus Therapeutics in a deal worth $1.7bn, marking a notable boost to the drugmaker’s renal disease pipeline. The agreement will give Novartis access to farabursen, a candidate in clinical development for autosomal dominant polycystic kidney disease (ADPKD). In ADPKD, the most common genetic cause of renal failure, small fluid-filled cysts gradually develop in the kidneys. Farabursen is an investigational microRNA inhibitor that aims to reduce the growth of cysts and kidney size, as well as delay progression of disease severity in patients with ADPKD. The drug, which targets miR-17, recently demonstrated promising efficacy and safety results in a phase 1b multiple-ascending dose clinical trial. According to Regulus, the candidate showed consistent impact on urinary polycystin, a biomarker of mechanistic response, and height-adjusted total kidney volume, a measure of progressive disease. Shreeram Aradhye, president, development and chief medical officer, Novartis, said farabursen “represents a potential first-in-class medicine with a profile that may provide enhanced efficacy, tolerability and safety versus standard of care”. “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,” Aradhye added. The transaction, which is expected to close in the second half of this year, includes an upfront payment of $800m and a potential $900m payment dependent on the achievement of a future regulatory milestone Regulus’ chief executive officer, Jay Hagan, said: “We are excited to combine with Novartis to potentially bring farabursen to patients living with ADPKD, who currently have limited treatment options. “Novartis’ established global development and commercial capabilities will enable this important new medicine to reach patients if approved.” The announcement comes less than three months after Novartis revealed that it would be expanding its late-stage cardiovascular pipeline by acquiring Anthos Therapeutics for approximately $3.1bn. The deal, expected to close in the first half of 2025, includes abelacimab, which is currently in phase 3 development for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

The upfront cash payment represents a significant premium over Regulus’ recent stock prices. Credit: Judith Linine/Shutterstock. Novartis has agreed to acquire US-based Regulus Therapeutics and its oligonucleotide, farabursen, to bolster its renal disease offerings. The upfront cash payment represents a significant premium over Regulus’ recent stock prices and a contingent value right (CVR) tied to regulatory milestones. Total consideration for the acquisition, including the CVR, could reach $1.7bn if the regulatory milestone is met. The transaction has received unanimous approval from both companies’ boards of directors. Novartis will commence a tender offer through an indirect wholly owned subsidiary to purchase all outstanding Regulus shares. Shareholders of Regulus will receive $7 per share in cash on closure, along with the CVR worth up to an additional $7 per share, contingent upon regulatory approval of the therapy. Post completion, Novartis plans to combine the acquiring subsidiary with Regulus, making it an indirect wholly owned subsidiary of the company. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Anticipated closure will take place in the second half of 2025, contingent on customary closing conditions, including the tender of a majority of Regulus’ common stock outstanding shares and necessary regulatory approvals. Both companies will operate as independent entitiesuntil then. Evercore is the exclusive financial advisor to Regulus, and Latham & Watkins is providing legal counsel. Regulus’ farabursen targets microRNA (miR)-17 with preferential kidney exposure and is intended for treating autosomal dominant polycystic kidney disease (ADPKD). The treatment decreases cyst growth and the size of the kidney, potentially delaying ADPKD’s severity. In March 2025, Regulus completed its Phase Ib multiple-ascending dose trial of the therapy, demonstrating safety and clinical efficacy. Novartis Development president and chief medical officer Shreeram Aradhye stated: “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.” In February 2025, Novartis agreed to acquire Anthos Therapeutics, a Boston-based clinical-stage biopharmaceutical company, for an upfront payment of $925m.

Novartis plans to acquire Regulus Therapeutics for $7.00 per share in cash, or $800 million, the microRNA specialist said Wednesday. The biotech’s share price $RGLS jumped more than 135% in premarket trading, surpassing the buyout price at more than $7.90 apiece. Regulus is based in San Diego, which has become a biotech hot spot. It will be the future home to one of Novartis’ new biomedical hubs, the company said earlier this month. The hub is part of a 10-site, $23 billion investment in American manufacturing and R&D over the coming five years. The deal marks the second acquisition of the year for Novartis. The Swiss drug giant brought one of its former experimental cardio medicines back into its fold, purchasing Anthos Therapeutics for $925 million upfront in February. Novartis was active on the M&A front in 2024 as well, with five small deals. For Regulus shareholders, the deal is split about evenly between upfront and down-the-road payments. The shareholders could get an additional $7.00 per share in cash through a contingent value right, which depends on the approval of Regulus’ lead candidate, farabursen. If this is exercised, the total value of the deal is around $1.7 billion. The deal is slated to close in the second half of this year. Ionis and Alnylam created Regulus as a joint venture in 2007. The biotech then went public via an IPO in October 2012 at $4.00 per share. Over the years, Regulus built up a rich pipeline of pharma partnerships with Sanofi, GSK and AstraZeneca, but the tie-ups eventually fumbled. Sanofi culled a mid-stage program in Alport syndrome after a Phase 2 failure; a clinical hold for a different drug in hepatitis C led to challenges in the GSK pact; and AstraZeneca reneged on rights to a drug for NASH , the fatty liver disease now known as MASH. Now, Regulus is headed toward a pivotal trial for farabursen. The oligonucleotide targets miR-17, and it’s being tested as a treatment for autosomal dominant polycystic kidney disease, the most common genetic cause of renal failure. Phase 1b data in March 2024 led the company’s stock price to skyrocket and an immediate $100 million boon to the company’s coffers via a private placement. In March of this year, Regulus said it had an agreement with the FDA on “key components” for a single Phase 3 trial for potential accelerated approval. Editor’s note: This story has been updated throughout to include additional details.