Novartis To Buy US Kidney Drug Developer Regulus Therapeutics For Around $800 Million

Novartis AG NVS agreed to acquire Regulus Therapeutics Inc. RGLS on Wednesday for an initial payment of $7.00 per share in cash or $0.8 billion.

The upfront cash portion of the consideration represents a premium of 274% to Regulus’ 60-day volume-weighted average stock price and 108% to Regulus’ closing price on April 29, 2025.

Regulus is a clinical-stage biopharmaceutical company developing microRNA therapeutics for severe renal disease and autosomal dominant polycystic kidney disease (ADPKD).

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The lead asset for ADPKD, farabursen, is a novel, next-generation oligonucleotide targeting miR-17 that recently completed a Phase 1b multiple-ascending dose clinical trial.

In addition, Regulus shareholders will receive a contingent value right (CVR) providing for payment of $7.00 per share, contingent upon the achievement of a milestone regarding the regulatory approval of Regulus’ lead product candidate, farabursen.

If the milestone is achieved, total consideration, including the CVR, would be approximately $1.7 billion.

The transaction is expected to close in the second half of 2025. Regulus will continue to operate as a separate and independent company.

In March, Regulus Therapeutics released topline results from all patients in the fourth cohort in its Phase 1b MAD study of farabursen (RGLS8429) for ADPKD.

Cohort 4 data highlights:

Increases in urinary PC1 and PC2 levels were similar to cohort 3 and reached a similar level of statistical significance compared to placebo (PC1 p=0.026; PC2 p=0.014).
The mean htTKV growth rate over 4 months was 0.05%, while placebo subjects in the trial experienced a mean growth rate of 2.58%.
Changes in htTKV were highly correlated with changes in renal cyst volume, suggesting farabursen directly impacts disease progression by limiting abnormal cyst growth.

Novartis strengthened its kidney disease portfolio after the U.S. Food and Drug Administration (FDA) granted accelerated approval for Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

This is Novartis' third U.S. approval for its kidney disease portfolio in the last year. Fabhalta was granted FDA approval in C3 glomerulopathy in March 2025 and accelerated approval in IgAN in August 2024.

Price Action: RGLS stock is up 132.9% at $7.85 during the premarket session at the last check Wednesday.

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