Novartis has successfully completed its acquisition of Regulus Therapeutics Inc., a strategic move that significantly bolsters its pipeline in renal disease by bringing the investigational drug farabursen under its wing. With the acquisition, Regulus is now an indirect, wholly-owned subsidiary of Novartis.

This partnership is centered on advancing farabursen, a promising next-generation oligonucleotide targeting miR-17. Farabursen is being developed to treat autosomal dominant polycystic kidney disease (ADPKD), the most common genetic cause of kidney failure worldwide. The drug aims to reduce cyst growth, decrease kidney size, and delay the progression of disease severity, addressing a critical unmet medical need as there are currently no preventive or therapeutic treatments for AKI.

This acquisition allows Novartis to significantly advance the clinical development of a potential first-in-class medicine aimed at treating patients suffering from autosomal dominant polycystic kidney disease (ADPKD), a condition with high unmet medical needs. The integration of the talented Regulus team further strengthens Novartis's growing pipeline in renal disease.

In March 2025, Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. The trial data showed promising clinical efficacy and safety, including a consistent impact on urinary polycystin (PC), a biomarker of mechanistic response, and height-adjusted total kidney volume (htTKV), an established clinical measure of disease progression. These positive results underscore the potential of this new partnership to deliver a meaningful therapy for ADPKD patients.

Novartis's tender offer to acquire all outstanding Regulus shares for $7.00 in cash per share, plus one contingent value right (CVR) for an additional $7.00 upon achieving a regulatory milestone, expired on June 24, 2025. Approximately 74.49% of Regulus's outstanding shares were tendered and accepted. Following the tender offer, Novartis completed the acquisition through a merger, converting all remaining outstanding shares into the same consideration offered.