A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.
STEIN, SWITZERLAND - FEBRUARY 18, 2020: Novartis is the second largest pharmaceutical company in the world. Novartis Pharma in Stein produces new medicaments and delivers them in 150 countries. | Image Credit: © Taljat - stock.adobe.com
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).
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.”
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."
The completion of the acquisition of Regulus, a company based in the United States, aligns with Novartis’ intention to expand its US manufacturing and R&D presence with the investment of $23 billion during the next five years, which Novartis announced in April 2025 (3). In addition to the planned construction of seven new facilities, Novartis said at the time that it would use $1.1 billion of the investment to create a research hub in San Diego—the location of Regulus’ headquarters.
Novartis’ announcement of its new investment within the US came a day after President Donald Trump levied, then placed a 90-day pause on, reciprocal taxes on countries the president had felt engaged in unfair trading practices, briefly sending a boomerang through US and worldwide stock markets (4). This action came roughly a week after the INTERPHEX 2025 conference in New York City, where Pharmaceutical Technology® Group interviewed key opinion leaders in the pharmaceutical industry about potential tariff impacts, and the push to increase onshoring.
Click here for a survey of those interviews and viewpoints from across the biopharmaceutical space.
1. Novartis. Novartis Completes Acquisition of Regulus Therapeutics. Press Release. June 25, 2025.
2. Regulus Therapeutics. Regulus Therapeutics Enters into Agreement to be Acquired by Novartis AG. Press Release. Apr. 30, 2025.
3. Novartis. Novartis Plans to Expand its US-Based Manufacturing and R&D Footprint with a Total Investment of $23B Over the Next 5 Years. Press Release. April 10, 2025.
4. Lavery, P. Tariff Pause Reinforces Uncertainty Among Biopharma Professionals. BioPharmInternational.com, April 10, 2025.
