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Regulus Therapeutics Inc. (NASDAQ: RGLS) is a pioneering biopharmaceutical company dedicated to discovering and developing novel medicines that target microRNAs. With a strong foundation in oligonucleotide drug discovery and development, Regulus has established a comprehensive pipeline of microRNA-based therapeutics and an advanced biomarkers platform known as MicroMarkersSM. The company’s intellectual property estate further solidifies its leadership in the microRNA field.
Regulus is at the forefront of developing innovative treatments for critical health issues. One of its significant projects includes RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 aimed at treating chronic hepatitis C virus infection. Another promising drug candidate is RG-012, which targets microRNA-21 for treating Alport Syndrome, a severe kidney disease driven by genetic mutations with no approved therapies currently available.
Moreover, Regulus, in collaboration with AstraZeneca, is working on RG-125, an anti-miR targeting microRNA-103/107 for treating non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes/pre-diabetes, which has already entered Phase I clinical development. Additionally, RGLS8429, an anti-miR next-generation oligonucleotide targeting miR-17, is in Phase 1b clinical development for treating autosomal dominant polycystic kidney disease (ADPKD).
Recently, Regulus reported positive topline data from the first and second cohorts of the Phase 1b MAD study of RGLS8429. The company has completed enrollment for the third cohort of this study, with topline data expected in mid-2024. The latest updates indicate the initiation of the fourth cohort in May 2024, focusing on a fixed dose of 300 mg of RGLS8429, which will provide further insights into its efficacy and safety.
Financially, Regulus is in a stable position, having recently raised $100 million through a private placement to institutional investors, extending its cash runway until the first half of 2026. For the quarter ended March 31, 2024, the company reported $107.7 million in cash and investments.
Regulus is committed to advancing its pipeline and bringing life-changing therapeutics to patients, with a particular focus on orphan kidney diseases. The company’s strategic collaborations and solid financial base are instrumental in driving its innovative research and development initiatives.
Regulus Therapeutics (Nasdaq: RGLS) announced that its director, David Baltimore, Ph.D., received the 2021 Lasker-Koshland Special Achievement Award for his significant contributions to virology, immunology, and cancer. This prestigious award celebrates advances in medical science and highlights the importance of public support for research. The CEO, Jay Hagan, praised Dr. Baltimore's extensive work and its influence on biotechnology and public health, including his role during the AIDS crisis. Regulus continues to benefit from his guidance in advancing its pipeline of microRNA therapeutics.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA therapeutics, announced that its CEO, Jay Hagan, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 a.m. ET. The presentation will be accessible via an on-demand webcast available on their investor relations website. A replay will be archived for 30 days. Regulus focuses on developing innovative medicines and holds a strong intellectual property portfolio in the microRNA sector.
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.
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