Novartis Acquires Regulus Therapeutics in Strategic Kidney Disease Play

Deal Overview

Novartis AG has entered into an agreement to acquire Regulus Therapeutics for an initial payment of $7.00 per share in cash, amounting to approximately $800 million1 2. The upfront cash portion represents a premium of 274% to Regulus' 60-day volume-weighted average stock price and 108% to Regulus' closing price on April 29, 20252. Additionally, Regulus shareholders will receive a contingent value right (CVR) providing for an additional payment of $7.00 per share, contingent upon achieving regulatory approval for Regulus' lead product candidate, farabursen2. If this milestone is achieved, the total consideration would reach approximately $1.7 billion2 4.

The acquisition has been unanimously approved by the Boards of Directors of both companies and is expected to be completed in the second half of 2025, subject to customary closing conditions2 4.

Strategic Rationale

The centerpiece of this acquisition is farabursen, an miRNA-targeting oligonucleotide being developed for autosomal dominant polycystic kidney disease (ADPKD)4 5. This rare, hereditary condition affects approximately 160,000 patients in the United States4. The acquisition aligns with Novartis' strategic ambition to become a leader in kidney disease treatment3.

Key Facts About Farabursen

Farabursen has shown promising results in clinical trials. In a phase 1b trial, patients who received the oligonucleotide every other week for three months experienced statistically significant increases in urinary PC1 and PC2, proteins that inversely correlate with disease severity3. Additionally, height-adjusted total kidney volume (htTKV), a predictor of renal insufficiency, increased only 0.05% over four months in patients on farabursen, compared to 2.58% in the placebo cohort3.

Regulus is planning to start a phase 3 trial that could support a filing for accelerated approval, with the trial expected to begin in the third quarter of 20253 5.

Keywords

Oligonucleotide therapeutics
microRNA (miRNA) targeting
Autosomal dominant polycystic kidney disease (ADPKD)
Rare kidney disease treatment
Pharmaceutical acquisition
Contingent value right (CVR)
Farabursen
Kidney disease portfolio expansion

This acquisition represents Novartis' commitment to expanding its presence in the kidney disease space while adding an innovative, phase 3-ready asset to its pipeline.