Novartis announced on June 25, 2025 that it has completed its acquisition of San Diego-based Regulus Therapeutics, making Regulus an indirect, wholly owned subsidiary of Novartis and ceasing trading of Regulus stock shares on the Nasdaq stock market (1).
Promising advancement in renal disease
Key Takeaways
- The $1.7 billion acquisition of Regulus adds farabursen—an oligonucleotide targeting miR-17 for ADPKD treatment—to Novartis' renal disease pipeline.
- Phase Ib trial results showed farabursen reduced kidney cyst growth and kidney size, supporting its potential as a first-in-class therapy for ADPKD.
- Regulus’ San Diego base aligns with Novartis’ $23 billion US expansion, which includes a new research hub planned for that city.
In a press release, Novartis spotlighted Regulus’ investigational next-generation oligonucleotide, farabursen, which targets the microRNA miR-17 with preferential kidney exposure (1). In March 2025, Regulus successfully completed a Phase Ib, multiple-ascending dose clinical trial for farabursen that showed promising efficacy and safety in reducing the growth of cysts and kidney size, as well as delaying the progression of autosomal dominant polycystic kidney disease (ADPKD).
“We are pleased to complete this transaction and take the next step in advancing clinical development for a potential first-in-class medicine that can help treat patients suffering from ADPKD, the most common genetic cause of renal failure worldwide,” said Shreeram Aradhye, president, Development and chief medical officer, Novartis, in the press release (1). “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.”
More than 56 million shares tendered
Regulus announced its pending acquisition by Novartis on April 30, 2025, disclosing that the deal was being made for $7 per share in cash with the potential to receive an additional $7 per share, also in cash, contingent on regulatory approval of farabursen (2). That arrangement, if realized in full, was calculated to bring the total equity value of the transaction to approximately $1.7 billion. Novartis said that more than 56 million shares were validly tendered, representing just under 75% of all issued and outstanding shares (1).
"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," Jay Hagan, CEO of Regulus Therapeutics, said at that time (2). "I am proud of the work that our team at Regulus has achieved in advancing this important new therapy and would like to thank all of the patients, investigators, and the ADPKD community in moving our program forward to this important milestone."