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Regulus Therapeutics Inc. (RGLS) is a biopharmaceutical innovator focused on developing microRNA-targeted therapies through advanced oligonucleotide technology. This page serves as the definitive source for official company announcements, research milestones, and regulatory developments.
Investors and researchers will find timely updates on clinical trial progress, including the Phase 1b study of RGLS8429 for autosomal dominant polycystic kidney disease (ADPKD). Our curated news collection provides essential insights into therapeutic advancements, partnership agreements, and strategic initiatives shaping the company's trajectory.
The repository features rigorously verified information across key categories: clinical program updates, financial disclosures, intellectual property developments, and scientific publications. Each entry maintains factual accuracy while highlighting implications for Regulus' position in the precision medicine landscape.
Bookmark this page for direct access to primary source materials from Regulus Therapeutics. Regularly updated content ensures stakeholders maintain current understanding of the company's progress in addressing complex diseases through RNA-targeted therapeutics.
Regulus Therapeutics (RGLS) has announced its Q1 2025 financial results and significant corporate updates. The company has entered into an acquisition agreement with Novartis for $7.00 per share in cash, plus a potential additional $7.00 per share through a CVR upon achieving regulatory milestones, valuing the deal at up to $1.7 billion. The transaction is expected to close in H2 2025.
The company reported positive topline data from the fourth cohort of its Phase 1b MAD study of farabursen (RGLS8429) for ADPKD treatment. The study demonstrated favorable safety profiles and efficacy in halting kidney volume growth. Regulus plans to initiate a Phase 3 pivotal trial in Q3 2025.
Q1 2025 financial results showed $65.4 million in cash and investments, with a net loss of $9.6 million ($0.15 per share). R&D expenses were $6.8 million, and G&A expenses were $3.7 million.
Novartis has agreed to acquire Regulus Therapeutics in a deal worth up to $1.7 billion. The acquisition offers $7.00 per share in upfront cash, representing a 274% premium over Regulus' 60-day volume-weighted average stock price. Shareholders will receive an additional $7.00 per share through a contingent value right (CVR) if certain milestones for their lead product farabursen are met.
The deal focuses on advancing treatment for ADPKD (the most common genetic cause of renal failure worldwide) through farabursen, which could become a first-in-class medicine. The transaction, unanimously approved by both companies' boards, is expected to close in the second half of 2025.
The merger requires tender of at least a majority of Regulus' shares and regulatory clearance. Evercore serves as financial advisor, with Latham & Watkins as legal counsel to Regulus.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicine development, has announced its participation in the 2025 Oppenheimer Innovation on the Island Biotech Summit.
CEO Jay Hagan will deliver a presentation on Wednesday, April 9th at 11:32 a.m. ET. Investors and interested parties can access both the live event and replay through the company's investor relations website at https://ir.regulusrx.com/events. The presentation recording will remain accessible for 90 days following the event.
Regulus Therapeutics (Nasdaq: RGLS) reported positive topline results from its Phase 1b Multiple-Ascending Dose clinical trial of farabursen (RGLS8429) for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The fourth cohort, involving 26 patients receiving 300mg fixed dose, demonstrated:
- Mean halting of height-adjusted total kidney volume (htTKV) growth over 4 months
- Significant increases in urinary PC1 (p=0.026) and PC2 (p=0.014) levels compared to placebo
- Mean htTKV growth rate of 0.05% vs placebo's 2.58%
An exploratory analysis of high-dose cohorts (n=35) showed statistical significance in htTKV change compared to historical placebo-treated patients (n=550), with treated patients experiencing -0.14% mean reduction vs +1.87% increase in placebo group (p=0.0056). The company plans to initiate a Phase 3 single pivotal trial in Q3 2025.
Regulus Therapeutics (RGLS) announced positive topline results from its Phase 1b multiple-ascending dose trial of farabursen (RGLS8429) for autosomal dominant polycystic kidney disease (ADPKD). The interim analysis of 14 subjects in the fourth cohort showed encouraging safety profiles and evidence of mechanistic dose response.
The company reached an agreement with the FDA on key components of a Phase 3 single pivotal trial design for potential Accelerated Approval. The trial includes a 12-month htTKV endpoint analysis.
Financial highlights for Q4 and full-year 2024:
- Cash position: $75.8 million, runway extending into early 2026
- Q4 R&D expenses: $9.7 million vs $5.8 million in 2023
- Q4 net loss: $12.8 million ($0.20 per share) vs $8.1 million ($0.40 per share) in 2023
- Full-year net loss: $46.4 million ($0.82 per share) vs $30.0 million ($1.58 per share) in 2023
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicine development, has announced its upcoming participation at the Leerink Partners 2025 Global Healthcare Conference. The company's management team will engage in a fireside chat scheduled for Tuesday, March 11th at 3:40 p.m. ET.
Investors and interested parties can access both the live presentation and its replay through the 'Events and Presentations' section on Regulus' investor relations website. The presentation recording will remain accessible for 90 days following the event.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicine development, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management team will engage in a fireside chat scheduled for Tuesday, February 11th at 2:40 p.m. ET.
Investors and interested parties can access both the live event and replay through the investor relations section of Regulus' website at https://ir.regulusrx.com/events. The presentation recording will remain accessible for 90 days following the event.
Regulus Therapeutics announced positive updates for its ADPKD treatment program with farabursen (RGLS8429). The fourth cohort of the Phase 1b Multiple-Ascending Dose study, involving 26 subjects receiving 300mg fixed doses, showed promising results. An interim analysis of 14 subjects demonstrated continued mechanistic dose response and notable reduction in height-adjusted total kidney volume (htTKV) growth rate.
The company also reported a successful End-of-Phase 1 meeting with the FDA, reaching agreement on key components for a Phase 3 single pivotal trial. The trial design includes a 2:1 randomization scheme with placebo, targeting a 12-month htTKV endpoint for potential Accelerated Approval and a 24-month eGFR endpoint for Full Approval.
Safety data from all 26 subjects showed farabursen was well tolerated, with effects on polycystin biomarker levels similar to the previous cohort. The results were consistent across Mayo Imaging Class and PKD1 mutations, with exploratory analyses suggesting high probability of meeting efficacy thresholds.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicines, has announced its participation in two major healthcare investment conferences. The company will present at the Evercore 7th Annual HealthCONx Conference on December 3, 2024, at 3:50 p.m. ET, and the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, at 11:10 a.m. ET. Both presentations will be accessible through live events and replays on the company's investor relations website for 90 days after the events.
Regulus Therapeutics has completed enrollment in the fourth cohort of its Phase 1b MAD clinical trial of RGLS8429 for treating ADPKD. The company presented promising data at ASN Kidney Week and is on track for an End-of-Phase 1 meeting with the FDA by year-end. Financially, Regulus ended Q3 2024 with $87.3 million in cash, ensuring a runway into H1 2026. R&D expenses increased to $11.3 million for Q3 2024, up from $5.5 million in Q3 2023. G&A expenses rose to $3.9 million, and the net loss widened to $14.1 million, or $0.21 per share, compared to $7.8 million, or $0.40 per share, in Q3 2023. Additionally, Regulus entered a licensing agreement with The University of Texas System, acquiring exclusive rights to patents targeting miR-17 for ADPKD treatment.
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