Welcome to our dedicated page for Regulus Therapeu news (Ticker: RGLS), a resource for investors and traders seeking the latest updates and insights on Regulus Therapeu stock.
Regulus Therapeutics Inc. (RGLS) is a biopharmaceutical company headquartered in San Diego, California, that focuses on the discovery and development of medicines targeting microRNAs. Its recent news flow has centered on its lead candidate, farabursen (RGLS8429), a next generation oligonucleotide designed to inhibit miR‑17 and preferentially target the kidney for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
News updates for RGLS commonly include clinical trial milestones for farabursen, such as topline data from the Phase 1b multiple-ascending dose (MAD) study in adult ADPKD patients. Regulus has reported mechanistic responses based on urinary polycystins 1 and 2 (PC1 and PC2), exploratory findings on height-adjusted total kidney volume (htTKV), and safety and tolerability data from multiple cohorts, including a fixed 300 mg dose regimen. Company releases also describe interactions with the U.S. Food and Drug Administration (FDA), including an End-of-Phase 1 meeting and alignment on key elements of a planned single pivotal Phase 3 trial with htTKV and eGFR endpoints.
Another major theme in Regulus news is corporate and transaction activity. The company announced an Agreement and Plan of Merger with Novartis AG, under which Novartis, through a subsidiary, launched a tender offer to acquire all outstanding Regulus shares for cash plus a non-tradeable contingent value right (CVR) tied to a regulatory milestone for farabursen. Subsequent disclosures report the successful completion of the tender offer and the closing of the merger, after which Regulus became an indirect wholly owned subsidiary of Novartis.
Additional RGLS news items include financial results for recent quarters and years, updates on cash runway expectations, and participation in healthcare and biotech investment conferences where management discusses the farabursen program and the company’s microRNA-targeting platform. For investors and researchers, the RGLS news page provides a consolidated view of clinical progress, regulatory interactions, transaction developments, and financial updates related to Regulus Therapeutics and its microRNA-based therapeutic strategy.
Regulus Therapeutics (Nasdaq: RGLS) has initiated dosing in a Phase 1b clinical study of RGLS4326 for patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This study aims to assess safety, pharmacokinetics, and biomarker changes in up to three cohorts. The first cohort will consist of nine patients receiving RGLS4326 biweekly for six weeks, with results expected by the end of Q1 2021. Regulus aims to use these results to address FDA requirements for extended-duration studies. RGLS4326 targets microRNAs to elevate polycystin levels linked to ADPKD.
Regulus Therapeutics (Nasdaq: RGLS) announced the receipt of $5 million from Sanofi as part of milestone and material payments related to its miR-21 programs. The company utilized these funds to pay down its term loan to approximately $9.6 million. Regulus is eligible for additional payments, including $5 million upon achieving an interim milestone and $25 million for a development milestone. The loan agreement with Oxford includes provisions for an additional interest-only period if the company pays down another $5 million by April 30, 2021.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that CEO Jay Hagan will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 11:00 AM EDT. This presentation will focus on the company’s innovative medicines targeting microRNAs. A live webcast will be available on the company’s investor relations website. Regulus specializes in oligonucleotide drug development and holds a robust intellectual property portfolio in the microRNA field.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that CEO Jay Hagan will present at the Wells Fargo Virtual Healthcare Conference on September 9, 2020, at 10:40 AM EDT. The event will be accessible via a live webcast on the company's website. Regulus focuses on developing medicines targeting microRNAs and possesses a robust intellectual property portfolio. The company is based in La Jolla, California.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced amendments to its loan agreement with Oxford LLC, allowing for up to seven months of interest-only payments if $10 million in principal is paid by April 30, 2021. Concurrently, the company restructured its agreement with Sanofi, resulting in a $1 million sale of materials and potential milestone payments totaling $9 million, with an additional $25 million milestone related to miR-21 compounds. CEO Jay Hagan expressed optimism about these agreements, which aim to ease financial pressures and extend operational flexibility.
Regulus Therapeutics (Nasdaq: RGLS) reported its Q2 2020 financial results, noting a net loss of $6.9 million, or $0.23 per share. Revenue was negligible, down from $6.8 million in Q2 2019. The company highlighted progress in its ADPKD program with the completion of the dosing for RGLS4326 in a clinical study. Additionally, RGLS4326 received Orphan Drug Designation from the FDA. The firm also announced advancements in its Hepatitis B program, where a lead compound demonstrated significant efficacy in preliminary studies.
Regulus Therapeutics Inc. (Nasdaq: RGLS) has announced that CEO Jay Hagan will present at the Wedbush PacGrow Healthcare Virtual Conference on August 12, 2020, at 2:20 PM EDT. Regulus focuses on innovative medicines targeting microRNAs, leveraging its expertise in oligonucleotide drug discovery. The company is based in La Jolla, California, and is actively engaged in preclinical and clinical studies, particularly with the RGLS4326 program. Forward-looking statements regarding its business, particularly amidst the COVID-19 pandemic, emphasize risks and uncertainties that could impact its operations.
Regulus Therapeutics (Nasdaq: RGLS) announced the appointment of Denis Drygin, Ph.D., as Chief Scientific Officer effective August 3, 2020. Dr. Drygin brings nearly 20 years of experience in drug discovery and development, previously serving at Pimera and Cylene Pharmaceuticals. CEO Jay Hagan expressed confidence in Dr. Drygin's expertise to enhance Regulus' innovative microRNA therapeutics pipeline. This strategic hire aims to strengthen the company's position in addressing high unmet medical needs in various indications.
Regulus Therapeutics (Nasdaq: RGLS) announced that the FDA has granted Orphan Drug Designation to its drug RGLS4326 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This designation offers significant benefits, including seven years of market exclusivity upon FDA approval, tax credits, and fee waivers. RGLS4326 is designed to inhibit miR-17 and targets the kidneys, demonstrating promising preclinical results in reducing cyst growth. A Phase 1b study for RGLS4326 in ADPKD patients is set to evaluate its safety and pharmacokinetics.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the successful completion of the Phase 1 multiple ascending dose study for RGLS4326, focusing on safety and tolerability in healthy volunteers. The study showed that RGLS4326 was well-tolerated with no serious adverse events reported, leading to plans for a Phase 1b open-label study in patients with autosomal dominant polycystic kidney disease (ADPKD). This upcoming study aims to evaluate the drug's safety and its potential to enhance biomarkers related to ADPKD, with results expected within six weeks after dosing.
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