Novartis announced the successful completion of its acquisition of Regulus Therapeutics, a clinical-stage biopharmaceutical company pioneering oligonucleotide therapies. With this milestone, Regulus becomes an indirect wholly owned subsidiary of Novartis, and its shares of common stock (par value $0.001) have officially ceased trading on the Nasdaq Stock Market.
“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,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. “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.”
Driving Innovation in Kidney Disease
At the center of this acquisition is farabursen, an investigational next-generation oligonucleotide therapy designed to target miR-17 with preferential exposure in the kidney. Its primary goal is to reduce kidney cyst growth and total kidney volume while slowing disease progression in patients with ADPKD.
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In March 2025, Regulus reported successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. The data demonstrated strong safety and promising efficacy, including consistent reductions in urinary polycystin (PC)—a biomarker of mechanistic response—and height-adjusted total kidney volume (htTKV), a key clinical measure used to track disease progression.
Terms of the Transaction
Novartis previously launched a tender offer to acquire all outstanding shares of Regulus for:
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$7.00 in cash per share, without interest and subject to applicable withholding, and
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One contingent value right (CVR) per share, offering an additional $7.00 in cash, contingent upon achieving a future regulatory milestone.
The tender offer expired at 12:01 a.m. (New York City time) on June 25, 2025. Approximately 56,374,397 shares—representing 74.49% of all issued and outstanding Regulus shares—were validly tendered and not withdrawn. All tendered shares were accepted and paid for in accordance with the terms of the offer.