Novartis announced the commencement of a tender offer to acquire Regulus on May 27, through its indirect wholly owned subsidiary, Redwood Merger Sub Inc.

The offer expired on June 24, and the transaction was closed on June 25. 

“We are excited to welcome the talented team at Regulus to Novartis as we continue to build on our pipeline in renal disease with high unmet medical need,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. 

With the completion of this transaction, Novartis is set to take the next step in advancing clinical development for a potential first-in-class medicine that can help treat patients suffering from autosomal dominant polycystic kidney disease (ADPKD), the most common genetic cause of renal failure worldwide.

ADPKD is characterised by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50 percent of ADPKD patients by age 60. 

The global prevalence of the disease is estimated to be around 4 to 7 million.

In March 2025, Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen, a new experimental drug designed to treat ADPKD.   

The drug works by targeting a molecule called miR-17, aiming to reduce the growth of cysts and kidney size, as well as delay progression of disease severity.

The trial demonstrated 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 key measure of disease progression in ADPKD.