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) reported its Q2 2021 financial results and key program developments, emphasizing progress in its ADPKD treatment program. Notably, the second cohort in the Phase 1b trial of RGLS4326 has been enrolled, with topline data expected soon. Financially, Regulus raised $15.4 million through an ATM facility and had $41.4 million in cash as of June 30, 2021. The net loss was $6.0 million for the quarter, improving from $6.9 million in the previous year. The company plans to discuss remaining clinical hold requirements with the FDA.
Regulus Therapeutics (Nasdaq: RGLS) will announce its financial results for Q2 2021 on August 10, 2021, after market close. The company will host a conference call at 5:00 PM ET on the same day to discuss the results and provide corporate updates. CEO Jay Hagan will also speak at the Wedbush PacGrow Healthcare Conference on August 11, 2021. Regulus focuses on developing innovative medicines targeting microRNAs and emphasizes its drug discovery expertise and intellectual property in this field. The release mentions forward-looking statements subject to various risks and uncertainties.
Regulus Therapeutics (Nasdaq: RGLS) announced new data from its Phase 1b clinical trial of RGLS4326 for treating autosomal dominant polycystic kidney disease (ADPKD) during the PKD Connect Conference 2021. The results indicate significant target engagement in kidneys, with increased urinary biomarkers PC1 and PC2, correlating inversely with disease severity. RGLS4326 was well-tolerated, showing no serious adverse events. Preclinical data demonstrated improved gene expression and kidney function in animal models. The trial is ongoing with further cohorts being enrolled.
Regulus Therapeutics (Nasdaq: RGLS) announced its presentation of new preclinical and clinical data on RGLS4326 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This will take place at the PKD Connect Conference on June 25, 2021. The Phase 1b trial aims to evaluate safety and efficacy across three patient cohorts, utilizing specific dosing regimens. Jay Hagan, CEO, emphasized the significance of sharing data that supports miR-17 as a therapeutic target. RGLS4326, targeting kidney microRNAs, shows promise in mitigating cyst growth and enhancing kidney function.
Regulus Therapeutics Inc. (Nasdaq: RGLS) provided an update on its Phase 1b clinical trial of RGLS4326 for patients with autosomal dominant polycystic kidney disease (ADPKD). Nine patients in the first cohort received 1 mg/kg doses every other week, leading to a mean increase in polycystin levels of 58% for PKD1 and 38% for PKD2, both statistically significant (p=.0004 and p=.026). The treatment was well-tolerated with no serious adverse events. Regulus plans to present further data at upcoming conferences, with the next cohort results expected in Q3 2021.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that CEO Jay Hagan will present at the Oppenheimer Rare & Orphan Disease Summit on May 21, 2021, at 11:35 A.M. ET. The conference will highlight innovative medicines targeting microRNAs. A live webcast of the presentation will be available on the company's investor relations website, with an archived replay for 30 days post-event. Regulus is dedicated to developing treatments based on its expertise in oligonucleotide drug discovery, bolstered by a strong intellectual property portfolio.
Regulus Therapeutics (Nasdaq: RGLS) announced financial results for Q1 2021, with a cash position of $31.6 million. Their clinical trial for RGLS4326 in treating ADPKD showed promising results, with PC1 and PC2 levels increasing by over 50% and 20%, respectively. RGLS4326 was well tolerated with no serious adverse events. Research and development expenses rose to $3.3 million, while general and administrative costs were $2.5 million. The net loss for the quarter was $6.0 million.
Regulus Therapeutics Inc. (Nasdaq: RGLS) will announce its financial results for Q1 2021 on May 13, 2021, after market close. A conference call will follow at 5:00 PM EDT, where the company will provide updates on its business and financial performance. Regulus specializes in developing innovative medicines targeting microRNAs, leveraging its drug discovery expertise for potential therapeutic applications. Investors are advised to be attentive to upcoming results and corporate updates, especially considering the potential impacts of COVID-19 on operations.
Regulus Therapeutics (Nasdaq: RGLS) announced promising top-line results from the first cohort of its Phase 1b clinical trial for RGLS4326, targeting patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Involving nine patients receiving 1 mg/kg doses, the trial demonstrated the drug's safety, with no serious adverse events and mild, transient effects observed. Notably, a significant increase of over 50% in the biomarker Polycystin 1 was recorded. Data from this cohort will be presented at the upcoming Kidney Week in November 2021.
Regulus Therapeutics Inc (Nasdaq: RGLS) has completed dosing for the first cohort of nine patients in its Phase 1b clinical trial of RGLS4326, focusing on autosomal dominant polycystic kidney disease (ADPKD). This trial aims to assess safety and pharmacokinetics of RGLS4326, with results expected in the coming weeks. The study includes multiple cohorts with varying doses, and RGLS4326 has shown promise in preclinical models by regulating Pkd1 and Pkd2. Notably, the drug is currently under a Partial Clinical Hold by the FDA for extended duration treatment.