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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 its expected inclusion in the Russell 3000® and Russell 2000® Indexes effective July 1, 2024, according to a preliminary list. This annual reconstitution captures the 4,000 largest US stocks by market capitalization as of April 30, 2024. Membership in the Russell 3000® Index means automatic inclusion in the large-cap Russell 1000® or small-cap Russell 2000® Indexes as well as growth and value style indexes. CEO Jay Hagan highlighted this achievement as a reflection of the company's forward momentum and the value of its pipeline, including the RGLS8429 program for ADPKD treatment. Russell indexes are important benchmarks for investment managers, with approximately $10.5 trillion in assets benchmarked against them as of December 2023.
Regulus Therapeutics (Nasdaq: RGLS) announced the promotion of Rekha Garg, M.D., M.S., to Chief Medical Officer, effective May 16, 2024. Previously, Dr. Garg was the Senior Vice President of Clinical Development and Regulatory. She has been with Regulus since 2022 and has played a key role in advancing RGLS8429, a treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Dr. Garg has over 20 years of experience in the biopharma industry, holding senior roles at Sanifit Therapeutics, Infinity Pharmaceuticals, Amgen, and Eli Lilly. She holds a B.A. in Biology, an M.D. from the Medical College of Ohio, and an M.S. in Epidemiology from the University of Maryland School of Medicine.
Regulus Therapeutics Inc. reported financial results for Q1 2024, showing a cash position of $107.7 million with a cash runway into H1 2026. The company initiated the fourth cohort in the Phase 1b MAD study of RGLS8429 for ADPKD, with topline data expected in mid-2024. Positive topline data from the second cohort indicated promising results in reducing kidney volume in patients with ADPKD. The company also closed an oversubscribed $100 million private placement in March 2024.
Regulus Therapeutics Inc. announced the advancement to cohort 4 of the Phase 1b Clinical Trial of RGLS8429 for the treatment of ADPKD. The study will evaluate the safety, efficacy, and impact on total kidney volume in patients with this disease. Positive data from previous cohorts has paved the way for this advancement, with potential for a pivotal Phase 2 trial. The trial aims to assess changes in urinary polycystins, kidney volume, cyst architecture, and overall kidney function.
Regulus Therapeutics Inc. will participate in the Canaccord Genuity Genetic Medicine for Generalists Webcast Series, with CEO Jay Hagan and President Preston Klassen, M.D. The event, hosted by Whitney Ijem on May 1, 2024, at 1:00 p.m. ET, will be live and available for replay on the company's investor relations website for 90 days.
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