HQ Team
April 30, 2025: Switzerland’s pharmaceutical company, Novartis AG, will acquire Regulus Therapeutics for about $1.7 billion to get access to a drug to treat a genetic kidney disease called autosomal dominant polycystic kidney disease.
Novartis will buy all the shares of Regulus for $7 per share, plus extra payments if the drug meets certain approval goals. The deal is expected to finish in the second half of 2025.
Regulus has a leading investigational drug called farabursen for treating autosomal dominant polycystic kidney disease (ADPKD). This disease causes many fluid-filled cysts to grow in the kidneys, making them bigger and eventually leading to kidney failure.
ADPKD is one of the most common inherited kidney diseases.
Slow cyst growth
Farabursen targets a specific microRNA called miR-17 that plays a role in the growth of these kidney cysts. By blocking miR-17, farabursen aims to slow down cyst growth, reduce kidney size, and delay how quickly the disease gets worse.
In early clinical trials, farabursen showed promising results. It was safe and helped reduce markers linked to kidney cyst growth and disease progression.
There are limited treatment options for ADPKD. Novartis already focuses on kidney diseases and has recently launched other kidney medicines. Adding farabursen to their portfolio could offer patients a new and better treatment option for this serious disease.
“The agreed deal is fully in line with the therapeutic area focus of Novartis and leverages our strength and expertise in renal disease,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis.
‘Efficacy, tolerability’
“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 worldwide. We look forward to investigating its (farabursen) potential further as we aim to bring a better treatment option to patients in need,” he said.
In March 2025, Regulus announced the successful completion of its early-stage multiple-ascending dose clinical trial for farabursen.
The trial data showed “promising clinical efficacy and safety, including consistent impact on urinary polycystin, a biomarker of mechanistic response, and height-adjusted total kidney volume, a measure of progressive disease,” according to a Novartis statement.
Indirect fully-owned subsidiary
Novartis will, through an indirect wholly owned subsidiary, commence a tender offer to purchase all outstanding shares of Regulus common stock.
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.
Novartis has received 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 of the same year.
The Nasdaq-listed Regulus Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs.
Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by an intellectual property estate in the microRNA field. The company is headquartered in San Diego, California.
