Novartis Acquires Regulus Therapeutics In Strategic Move To Expand RNA Drug Pipeline

Novartis has announced the successful completion of its acquisition of Regulus Therapeutics Inc. With the closing of the deal, Regulus has become an indirect wholly owned subsidiary of Novartis, and its common stock is no longer traded on the Nasdaq Stock Market. Regulus is known for its work in developing RNA-targeted therapies, and the acquisition brings its lead investigational candidate, farabursen, into Novartis’ pipeline. Farabursen is a next-generation oligonucleotide designed to target miR-17, a molecule implicated in the progression of autosomal dominant polycystic kidney disease (ADPKD). 

The therapy is engineered for preferential delivery to the kidneys, with the aim of reducing cyst growth, slowing kidney enlargement, and delaying overall disease progression. In March 2025, Regulus announced positive results from a Phase 1b multiple-ascending dose trial of farabursen. The study demonstrated encouraging safety and efficacy data, including consistent effects on urinary polycystin (PC), a key biomarker of disease mechanism and height-adjusted total kidney volume (htTKV), a well-established clinical measure for ADPKD progression.

The acquisition was carried out through a previously announced tender offer in which Novartis offered to purchase all outstanding shares of Regulus for $7.00 in cash per share, along with one contingent value right (CVR) per share. The CVR entitles shareholders to an additional $7.00 in cash if a specified regulatory milestone is met. The tender offer expired at 12:01 a.m. New York City time on June 25, 2025. At the time of expiration, approximately 56,374,397 shares had been validly tendered and not withdrawn, representing around 74.49% of the total outstanding shares. These shares were accepted and paid for in accordance with the terms of the offer.

Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis, mentioned, “We are pleased to complete this transaction and take the next step in advancing clinical development for a potential first-in-class medicine that can help treat patients suffering from ADPKD (autosomal dominant polycystic kidney disease), the most common genetic cause of renal failure worldwide. We are excited to welcome the talented team at Regulus to Novartis as we continue to build on our pipeline in renal disease with high unmet medical need.”

Following the tender offer, Novartis completed the acquisition by merging its indirect wholly owned subsidiary, Redwood Merger Sub Inc., with Regulus under Section 251(h) of the Delaware General Corporation Law. This step did not require a separate vote from Regulus shareholders. As a result of the merger, all remaining shares of Regulus that had not been tendered were canceled and automatically converted into the right to receive the same consideration offered in the tender, including the CVR. This transaction adds a potentially impactful treatment for ADPKD to Novartis' research portfolio and strengthens its position in the field of nephrology.