Novartis to acquire Regulus Therapeutics in US $1.7B deal

SWITZERLAND – Swiss pharmaceutical giant Novartis has announced its plan to acquire Regulus Therapeutics, a San Diego-based biotech firm, in a deal valued at up to US $1.7 billion.

The acquisition centers around Regulus’s experimental therapy, farabursen (formerly RGLS8429), aimed at treating autosomal dominant polycystic kidney disease (ADPKD), a prevalent genetic disorder leading to kidney failure.

Under the agreement, Novartis will make an upfront payment of US $800 million, equating to $7 per share—a 108% premium over Regulus’s last closing stock price.

An additional US $7 per share is contingent upon achieving specific regulatory milestones related to farabursen’s development and approval.

The transaction is expected to close in the second half of 2025, pending customary closing conditions.

Farabursen is an investigational microRNA inhibitor designed to treat autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder characterized by the growth of numerous cysts in the kidneys, leading to progressive kidney failure.

In a Phase 1b multiple-ascending dose (MAD) clinical trial, farabursen demonstrated promising results, including a mean reduction in height-adjusted total kidney volume (htTKV) growth rate of -0.14% compared to a 1.87% increase in the placebo group, achieving statistical significance (p=0.0056).

ADPKD affects approximately 160,000 individuals in the United States and between 4 to 7 million globally.

Currently, the only FDA-approved treatment is Otsuka’s Jynarque (tolvaptan), approved in 2018, which had estimated U.S. sales of US $1.5 billion last year.

Farabursen has the potential to offer a more targeted and tolerable treatment option for patients. This acquisition aligns with Novartis’s strategic focus on expanding its renal portfolio.

The company has been actively investing in kidney disease therapies, including the acquisition of Chinook Therapeutics for US $3.2 billion in 2023, which added two late-stage assets for IgA nephropathy to its pipeline.

Shreeram Aradhye, Novartis’ Chief Medical Officer, stated, “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.”