Regulus Therapeu Stock Price, News & Analysis
Company Description
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company focused on the discovery and development of medicines that target microRNAs. According to the company, it has leveraged its oligonucleotide drug discovery and development expertise to build a pipeline of microRNA-targeting therapeutics supported by a substantial intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in San Diego, California.
The company describes itself as concentrating on the development of innovative medicines targeting microRNAs, a class of small, non-coding RNAs that regulate gene expression. Its work is based on oligonucleotide chemistry and microRNA biology, with the goal of modulating disease processes by inhibiting specific microRNAs. Regulus states that its pipeline is complemented by a rich intellectual property position around microRNA therapeutics.
Focus on ADPKD and Farabursen (RGLS8429)
Recent company disclosures highlight farabursen (RGLS8429) as Regulus Therapeutics’ lead product candidate. Farabursen is described as a novel, next generation oligonucleotide for the treatment of autosomal dominant polycystic kidney disease (ADPKD). It is designed to inhibit miR-17 and to preferentially target the kidney. In preclinical models, administration of farabursen has shown improvements in kidney function, kidney size, and other measures of disease severity, based on the company’s reports.
Regulus has conducted a Phase 1 single-ascending dose (SAD) study and a Phase 1b multiple-ascending dose (MAD) study of farabursen in adult patients with ADPKD. The Phase 1 SAD study demonstrated a favorable safety and pharmacokinetic profile, with farabursen reported as well-tolerated and plasma exposure approximately linear across the doses tested. In the Phase 1b MAD study, Regulus evaluated farabursen across three weight-based dose levels and one fixed dose level, with primary endpoints including changes in urinary polycystins 1 and 2 (PC1 and PC2) and exploratory evaluation of height-adjusted total kidney volume (htTKV).
In the fourth cohort of the Phase 1b MAD study, patients received a fixed dose of 300 mg of farabursen every other week for three months. According to topline data released by Regulus, this cohort showed mechanistic responses based on urinary PC1 and PC2 levels and results suggesting a mean halting of htTKV growth over the four-month study period. Across cohorts, the company reports that farabursen was well tolerated and that observed biomarker responses and imaging findings potentially support advancement into a pivotal Phase 3 trial design, with a 12‑month htTKV endpoint for potential Accelerated Approval and a 24‑month eGFR endpoint for potential Full Approval, as discussed with the U.S. Food and Drug Administration (FDA).
MicroRNA-Targeted Therapeutics Platform
Regulus describes itself as having oligonucleotide drug discovery and development expertise focused on microRNAs. The company reports that it has developed a pipeline of microRNA-targeting candidates and holds a rich intellectual property estate in the microRNA field. In past descriptions, Regulus has characterized its work as building microRNA therapeutics and associated biomarker capabilities based on its platform.
The company’s disclosures emphasize the role of miR‑17 in ADPKD and the design of farabursen to inhibit this microRNA. Regulus has also reported work on earlier-generation anti‑miR compounds and the refinement of its chemistry to address off‑target effects, which informed the development of RGLS8429/farabursen.
Corporate Transactions and Listing Status
Regulus Therapeutics entered into an Agreement and Plan of Merger with Novartis AG and an indirect wholly owned subsidiary of Novartis. Under this agreement, Novartis commenced a tender offer to acquire all outstanding shares of Regulus common stock for a cash amount per share plus a non-tradeable contingent value right (CVR) tied to a regulatory milestone related to farabursen. A Form 8‑K filed by Regulus reports that the tender offer expired on June 24, 2025, that the minimum tender condition and other conditions were satisfied, and that Merger Sub irrevocably accepted for payment all shares validly tendered and not validly withdrawn.
On June 25, 2025, following the tender offer, Novartis completed the acquisition of Regulus by causing the merger of its subsidiary with and into Regulus. As described in the Form 8‑K, Regulus continued as the surviving corporation and became an indirect wholly owned subsidiary of Novartis. At the effective time of the merger, each issued and outstanding share of Regulus common stock (subject to specified exceptions) was automatically canceled and converted into the right to receive the offer consideration, including the CVR, subject to applicable terms.
In connection with the completion of the merger, Regulus notified The Nasdaq Stock Market LLC of the consummation of the transaction and requested the filing of a Form 25 to remove its common stock from listing and registration on Nasdaq. A Form 25 filed on June 25, 2025, by Nasdaq Stock Market LLC relates to the removal of Regulus Therapeutics Inc. common stock from listing and/or registration under Section 12(b) of the Securities Exchange Act of 1934. Subsequently, Regulus filed a Form 15 on July 7, 2025, certifying the termination of registration under Section 12(g) of the Exchange Act and the suspension of its duty to file reports under Sections 13 and 15(d). The Form 15 notes that the approximate number of holders of record as of the certification date was one.
Implications for RGLS Stock
Based on the Form 8‑K, Form 25, and Form 15, Regulus Therapeutics Inc. common stock is no longer listed on Nasdaq and its registration under Section 12 of the Exchange Act has been terminated. The company is now an indirect wholly owned subsidiary of Novartis, and its public reporting obligations under Sections 13 and 15(d) have been suspended. Historical references to RGLS stock therefore relate to the period prior to the completion of the acquisition and delisting.
ADPKD Disease Context (Company-Provided)
In its public communications, Regulus describes autosomal dominant polycystic kidney disease (ADPKD) as a common human monogenic disorder caused by mutations in the PKD1 or PKD2 genes and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid-filled cysts primarily in the kidneys, with excessive kidney cyst cell proliferation ultimately leading to end-stage renal disease in a substantial portion of patients by age 60. The company cites estimates of diagnosed individuals in the United States and an estimated global prevalence in the millions.
Position Within Pharmaceutical Preparation Manufacturing
Within the broader pharmaceutical preparation manufacturing sector, Regulus is described as a biopharmaceutical company with a specific focus on microRNA-targeting oligonucleotides. Its disclosed activities center on research and clinical development rather than on commercial-scale manufacturing, with farabursen for ADPKD as its primary clinical-stage asset according to recent company communications.
Key Points for Investors and Researchers
- Regulus Therapeutics Inc. is a biopharmaceutical company focused on medicines targeting microRNAs, with headquarters in San Diego, California.
- The company has developed a pipeline based on oligonucleotide drug discovery and reports a rich intellectual property estate in the microRNA field.
- Farabursen (RGLS8429), designed to inhibit miR‑17 and preferentially target the kidney, is the company’s lead candidate for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
- Phase 1 SAD and Phase 1b MAD studies of farabursen in adult ADPKD patients have been conducted, with company-reported favorable safety, pharmacokinetic characteristics, and biomarker and imaging findings that support progression to a planned pivotal Phase 3 trial.
- Regulus entered into a merger agreement with Novartis AG; following a tender offer and subsequent merger completed on June 25, 2025, Regulus became an indirect wholly owned subsidiary of Novartis.
- A Form 25 filed on June 25, 2025, and a Form 15 filed on July 7, 2025, indicate that Regulus common stock has been delisted from Nasdaq and its registration under the Exchange Act has been terminated, with reporting obligations suspended.