Novartis completes acquisition of Regulus Therapeutics

By, Admin 27 June 2025

Overview

Novartis today announced that it has successfully completed its acquisition of Regulus Therapeutics Inc. (“Regulus”). With the completion of the acquisition, shares of common stock, par value $0.001 per share (the “Shares”), of Regulus, have ceased trading on the Nasdaq Stock Market LLC and Regulus is now an indirect wholly owned subsidiary of Novartis.

Statement from the Shreeram Aradhye: CMO, Novartis

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 worldwide1,” 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.”

The novel oligonucleotide targeting drug: Farabursen

Farabursen is an investigational next-generation oligonucleotide targeting miR-17 with preferential kidney exposure, aiming to reduce the growth of cysts and kidney size, as well as delay progression of disease severity in ADPKD.
In March 2025, Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen.
The Phase 1b trial data showed promising clinical efficacy and safety, including consistent impact on urinary polycystin (PC), a biomarker of mechanistic response, and height-adjusted total kidney volume (htTKV), an established meaningful clinical measure of disease progression.

Novartis Successfully Completes Tender Offer for Regulus Shares

Novartis’ tender offer to acquire all outstanding Regulus shares has expired as of 12:01 a.m. (ET) on June 25, 2025. Under the offer, shareholders will receive:

$7.00 in cash per share, and

One contingent value right (CVR) per share, representing a potential additional $7.00 payment upon achievement of a regulatory milestone.

Approximately 56,374,397 shares were validly tendered and not withdrawn, representing 74.49% of Regulus’ outstanding shares.
All tendered shares have been accepted for payment and the payment process has been initiated in accordance with the offer terms.
This marks a significant step in Novartis’ acquisition of Regulus, further integrating its RNA-based therapeutic capabilities.

Novartis Completes Merger with Regulus, Finalizing Full Acquisition

Following completion of the tender offer, Novartis completed the acquisition of Regulus through the merger of its indirect wholly owned subsidiary, Redwood Merger Sub Inc., with and into Regulus, without a vote of Regulus’ stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware.
As a result of the merger, each Share issued and outstanding and not tendered in the tender offer was canceled and extinguished and automatically converted into the right to receive the same consideration (including the CVR) per Share payable in the tender offer.

Disclaimer

This press release includes forward-looking statements, which are not historical facts and involve known and unknown risks and uncertainties.
These statements relate to, among other things:
The acquisition of Regulus by Novartis
The clinical and commercial potential of farabursen
Expected benefits or synergies from the acquisition
Possible future revenues, marketing approvals, or label expansions for farabursen.
Forward-looking language includes terms such as “potential,” “expect,” “plan,” “believe,” “may,” “will,” “anticipate,” and similar expressions.
These statements are based on current assumptions and expectations, which may prove incorrect due to:
Regulatory delays or failures
Clinical trial uncertainties
Market dynamics, pricing pressures, or commercial performance
Disruption or uncertainty from the transaction itself
Stockholder litigation, management distractions, or legal obligations related to CVR milestones.
Broader economic, political, or competitive conditions

There is no guarantee that:

- Farabursen trials will succeed
- It will be submitted or approved for marketing
- It will achieve commercial success
- The transaction benefits or milestone payments will materialize

• Novartis and Regulus disclaim any obligation to update forward-looking statements unless legally required, and encourage readers to review their latest filings with the U.S. SEC, including annual and quarterly reports, for a comprehensive understanding of associated risks.

About Novartis

Novartis is an innovative medicines company.
Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.
Our medicines reach nearly 300 million people worldwide.

Kymera Therapeutics & Sanofi Advance KT-485 into Clinical Development for Immune Diseases
Overview
Kymera Therapeutics has announced an update regarding its partnership with Sanofi on the IRAK4 programme.

KT-485: an anti-inflammatory molecule & its MOA

KT-485 is designed to treat immuno-inflammatory diseases where significant unmet need remains. IRAK4 plays a key role in regulating innate immunity and inflammatory signalling through IL-1 and toll-like receptors.
Unlike traditional small molecule inhibitors, KT-485 works by degrading IRAK4, potentially affecting both its kinase and scaffolding functions.
This mechanism may offer a more comprehensive and well-tolerated anti-inflammatory response.

Development of KT-485 for future

Sanofi has selected KT-485 (also known as SAR447971), an oral, potent, and selective IRAK4 degrader, to move forward into clinical development.
KT-485 was discovered and developed by Kymera through extensive preclinical studies.
It will now be prioritised under the companies’ existing collaboration, with Phase 1 trials expected to begin in 2026.
As a result of this decision, Sanofi will no longer continue development of KT-474, an earlier candidate in the same programme.

Terms of agreement

In line with this development, Sanofi has chosen to exercise its participation rights under the terms of the collaboration.
Kymera has received a milestone payment of US$20 million in Q2 2025 related to KT-485’s preclinical progress.
The company remains eligible for up to US$975 million in future clinical, regulatory, and commercial milestones, including a payment once KT-485 enters Phase 1 trials.
Sanofi and Kymera will continue their collaboration in this area, excluding oncology and immuno-oncology indications.

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