Novartis Completes Acquisition of Regulus Therapeutics to Advance ADPKD Treatment Pipeline

Novartis Completes Acquisition of Regulus Therapeutics to Advance ADPKD Treatment Pipeline
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Novartis has officially completed its acquisition of Regulus Therapeutics Inc., making the company an indirect wholly owned subsidiary. As a result, Regulus’ common stock has been delisted from the Nasdaq Stock Market.

“We’re excited to finalize this acquisition and accelerate the development of a potential first-in-class therapy for autosomal dominant polycystic kidney disease (ADPKD)—the leading genetic cause of kidney failure globally,” said Shreeram Aradhye, President, Development and Chief Medical Officer at Novartis. “We look forward to integrating Regulus’ talented team as we strengthen our renal disease pipeline, focusing on areas with significant unmet need.”

The acquisition includes farabursen, an investigational next-generation oligonucleotide that selectively targets miR-17 and shows preferential kidney distribution. It is being developed to reduce kidney cyst growth, shrink total kidney size, and slow ADPKD progression. In March 2025, Regulus announced the successful completion of a Phase 1b multiple-ascending dose trial, with data demonstrating encouraging safety and efficacy results. These included a consistent reduction in urinary polycystin (PC), a biomarker of therapeutic response, and improvements in height-adjusted total kidney volume (htTKV), a key clinical indicator of disease severity.

Novartis had previously launched a tender offer to acquire all outstanding Regulus shares for $7.00 in cash per share, plus an additional $7.00 per share contingent value right (CVR) tied to the achievement of a future regulatory milestone. The offer expired on June 24, 2025, with approximately 74.49% of shares validly tendered and accepted for payment.

Following this, Novartis completed a merger via its indirect subsidiary, Redwood Merger Sub Inc., under Delaware law, eliminating the need for a shareholder vote. All remaining Regulus shares not tendered were converted into the same consideration as in the tender offer, including the CVR.

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