Novartis Finalizes Acquisition of Regulus Therapeutics, Strengthening Its Renal Disease Portfolio with Promising ADPKD Therapy
Novartis AG, a leading global pharmaceutical company, has officially completed its acquisition of Regulus Therapeutics Inc., a biotechnology firm known for its expertise in microRNA-targeting therapies. The deal marks a significant step in Novartis’ strategic expansion into kidney disease therapeutics, particularly for autosomal dominant polycystic kidney disease (ADPKD)—a genetic condition that is among the most prevalent inherited causes of kidney failure worldwide.
With the acquisition finalized, Regulus Therapeutics has ceased to operate as an independent publicly traded company. As of the closing of the transaction, all shares of Regulus common stock, previously traded on the Nasdaq Stock Market under the ticker symbol RGLS, have been delisted. Regulus now functions as an indirect wholly owned subsidiary of Novartis, further reinforcing the Swiss pharmaceutical giant’s presence in the renal disease therapeutic space.
Advancing a First-in-Class Therapy for ADPKD
Commenting on the completion of the acquisition, Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, stated:
“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, 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.”
At the heart of this acquisition lies farabursen, an investigational oligonucleotide therapeutic being developed by Regulus. This next-generation therapy targets miR-17, a microRNA implicated in the progression of ADPKD. Unlike traditional therapeutics, farabursen is designed for preferential kidney exposure, a highly targeted approach that aims to reduce cyst formation and kidney enlargement, two hallmarks of ADPKD progression. The drug’s mechanism also aims to delay the overall progression of disease severity—an urgent need in a patient population that often progresses to end-stage renal disease.
In March 2025, Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. The results demonstrated promising efficacy and a favorable safety profile. Importantly, farabursen showed consistent modulation of urinary polycystin (PC) levels—a key biomarker reflecting therapeutic engagement with the target pathway. Additionally, treatment led to improvements in height-adjusted total kidney volume (htTKV), an established clinical marker that correlates with disease progression in ADPKD. These data were viewed as both mechanistically and clinically meaningful, laying the groundwork for future mid- and late-stage development.
Financial Structure of the Acquisition
The acquisition was executed through a tender offer launched by Novartis earlier this year. Under the terms of the offer, Novartis proposed to purchase all outstanding shares of Regulus Therapeutics for a combination of $7.00 in cash per share, along with one contingent value right (CVR) for each share tendered. The CVR entitles shareholders to a potential additional payment of $7.00 in cash, contingent upon the achievement of a specified regulatory milestone—a common practice in biotech acquisitions where the lead program is still in early clinical stages.
The tender offer officially expired at 12:01 a.m. Eastern Time on June 25, 2025. Upon its expiration, approximately 56,374,397 shares had been validly tendered and not withdrawn, representing around 74.49% of the total outstanding shares of Regulus. All shares tendered were accepted for purchase and promptly paid for by Novartis.
With the majority of shares secured through the tender process, Novartis then proceeded to consummate the acquisition via a short-form merger, a legal mechanism made possible under Section 251(h) of the Delaware General Corporation Law. In this type of merger, a parent company can acquire the remaining shares without a stockholder vote, provided certain thresholds are met. In this case, Redwood Merger Sub Inc., an indirect wholly owned subsidiary of Novartis, was merged with and into Regulus. Upon the merger’s completion, Regulus’ remaining shares—those that had not been tendered—were canceled and converted into the right to receive the same consideration as offered in the tender offer: $7.00 in cash and one CVR per share.
Strategic Rationale and Industry Impact
The acquisition of Regulus represents a strategic and scientifically compelling move by Novartis to bolster its therapeutic pipeline in renal diseases, particularly those with genetic underpinnings. ADPKD affects millions worldwide and currently has very limited treatment options, with most therapies focused on managing symptoms rather than altering disease progression.
By integrating Regulus’ expertise in microRNA science with its own deep capabilities in clinical development, regulatory affairs, and commercialization, Novartis is well-positioned to accelerate farabursen’s clinical path and potentially bring a first-in-class treatment to ADPKD patients.
The move also reinforces a broader trend within the pharmaceutical industry: the growing interest in RNA-based therapeutics, including oligonucleotides and microRNA modulators. These modalities offer a new layer of precision in targeting diseases that are difficult to address with conventional small molecules or biologics. With companies like Alnylam, Ionis, and Moderna pushing the boundaries in RNA therapeutics, Novartis’ acquisition of Regulus signals its renewed commitment to innovation in this space.
Now that the transaction is finalized, Novartis will begin the process of fully integrating Regulus’ operations, research assets, and staff into its own global structure. According to insiders, the Regulus team will continue to operate from its existing facilities during a transition period, with R&D personnel expected to play key roles in the further development of farabursen and other microRNA-targeting candidates.
The development of farabursen is expected to move into Phase 2 clinical trials in the second half of 2025, pending regulatory clearance. These upcoming studies will evaluate the drug’s impact on a broader ADPKD patient population over a longer treatment duration, with endpoints likely to include changes in kidney volume, renal function, and patient-reported outcomes.
For Novartis, the success of farabursen could represent not just a new treatment option, but a platform opportunity in using microRNA modulation for a variety of diseases where gene expression regulation plays a central role.
With the completion of the Regulus Therapeutics acquisition, Novartis has taken a decisive step forward in its renal disease strategy, acquiring both a promising drug candidate in farabursen and the scientific expertise to further leverage RNA therapeutics in nephrology and beyond. The deal exemplifies Novartis’ ambition to redefine standards of care in areas of high unmet need through innovative science and strategic investment.
As the biotech industry continues to evolve, acquisitions like this reflect the increasing convergence of genetic insights, RNA-targeting technologies, and large-scale pharmaceutical infrastructure—unlocking new possibilities for patients with rare and serious conditions such as ADPKD.
