Novartis Acquires Regulus Therapeutics for $1.7 Billion, Expanding Kidney Disease Portfolio

Novartis has made a significant move to bolster its position in the kidney disease market by agreeing to acquire Regulus Therapeutics for up to $1.7 billion. The deal, announced on April 30, 2025, centers around Regulus' promising phase 3-ready drug candidate for a rare renal condition.

Acquisition Details and Financial Terms

The Swiss pharmaceutical giant will pay $800 million upfront, or $7 per share, to acquire Regulus Therapeutics. This represents a premium of more than double Regulus' closing stock price on the day before the announcement. An additional $7 per share, potentially bringing the total deal value to $1.7 billion, is contingent upon achieving regulatory approval for farabursen, Regulus' lead candidate.

Farabursen: A Potential Breakthrough in ADPKD Treatment

Farabursen, an oligonucleotide therapy, is being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The drug showed promising results in a recent phase 1b trial:

• Patients receiving farabursen every other week for three months experienced statistically significant increases in urinary PC1 and PC2 proteins, which inversely correlate with disease severity.
• Height-adjusted total kidney volume (htTKV), a predictor of renal insufficiency, increased by only 0.05% over four months in patients on farabursen, compared to a 2.58% increase in the placebo group.

These encouraging results have paved the way for a phase 3 trial, set to begin in the third quarter of this year. The trial is designed to support a filing for accelerated approval based on htTKV changes after 12 months, with a 24-month follow-up to assess changes in kidney function (eGFR) for full approval.

Strategic Implications for Novartis

This acquisition aligns with Novartis' ambition to become a leader in kidney disease treatment. The company has been actively building its renal portfolio through various means:

• The $3.2 billion acquisition of Chinook Therapeutics
• Development of internal programs
• Recent launches of kidney disease treatments Fabhalta and Vanrafia

Farabursen, if approved, would enter a market currently dominated by Otsuka's Samsca. However, Samsca's uptake has been limited, with only about 7% of the addressable ADPKD population using the drug, largely due to safety and tolerability concerns. Regulus believes farabursen has the potential to capture a larger market share and become a multibillion-dollar opportunity.

The deal underscores Novartis' commitment to expanding its presence in the renal disease space and highlights the growing importance of targeted therapies for rare kidney disorders in the pharmaceutical industry.