NovartisNovartis today announced that it has entered into an agreement to acquire Regulus Therapeutics, a San Diego-based, publicly traded (Nasdaq: RGLS) clinical-stage biopharmaceutical company focused on developing microRNA therapeutics. Regulus' lead asset, farabursen, is a potential first-in-class, next-generation oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The agreed deal is fully in line with the therapeutic area focus of Novartis and leverages our strength and expertise in renal disease.

"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. "ADPKD is the most common genetic cause of renal failure worldwide(1). 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 an investigational microRNA inhibitor designed to target miR-17 with preferential kidney exposure, aiming to reduce the growth of cysts and kidney size, as well as delay progression of disease severity in ADPKD. In March 2025, Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. The Phase 1b trial data showed promising clinical efficacy and safety, including consistent impact on urinary polycystin (PC), a biomarker of mechanistic response, and height-adjusted total kidney volume (htTKV), a measure of progressive disease.

Transaction details

Under the terms of the transaction, which has been unanimously approved by the Boards of Directors of both companies, Novartis will, through an indirect wholly owned subsidiary, commence a tender offer to purchase all outstanding shares of Regulus common stock. Holders of Regulus common stock would receive USD 7 per share in cash at closing and a contingent value right ("CVR") with a value of up to USD 7 per share payable in cash upon the achievement of a regulatory milestone.

Following completion of the tender offer, Novartis expects to merge the acquiring subsidiary with Regulus, resulting in Regulus becoming an indirect wholly owned subsidiary of Novartis.

The transaction is expected to close in the second half of 2025, subject to the satisfaction or waiver of customary closing conditions, including the tender of a majority of the outstanding shares of Regulus common stock and the receipt of regulatory approvals. Until closing, Novartis and Regulus will continue to operate as separate and independent companies.

Novartis in renal disease

Building on a 40-year legacy that began with innovations in transplantation, Novartis is dedicated to transforming kidney health by addressing conditions with significant unmet need. This commitment is reflected in three FDA approvals in renal care within nine months, including Vanrafia® in IgA nephropathy (IgAN) in April 2025, and Fabhalta® for C3 glomerulopathy (C3G) and IgAN in March 2025 and August 2024.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

1. Muddassar Mahboob, et al. Autosomal Dominant Polycystic Kidney Disease. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532934/