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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 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.
Regulus Therapeutics (Nasdaq: RGLS) has completed enrollment of 26 patients in the fourth cohort of its Phase 1b Multiple-Ascending Dose (MAD) clinical trial for RGLS8429, targeting Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study has shown positive results from previous cohorts, demonstrating a mechanistic dose response based on increased urinary polycystins (PC1 and PC2). Exploratory imaging analysis revealed mean reductions in height adjusted total kidney volume (htTKV). The company plans an End of Phase 1 meeting with the FDA by the end of 2024 and expects to share topline data from cohort four in early 2025. The Phase 1b MAD study is evaluating safety, tolerability, and pharmacokinetics/pharmacodynamics of RGLS8429 across different dose levels in ADPKD patients.
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on developing innovative medicines targeting microRNAs, has announced its participation in two upcoming healthcare investment conferences. The company will be presenting at the Wells Fargo Healthcare Conference on September 4, 2024, at 2:15 p.m. ET, and the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 10:00 a.m. ET.
Both presentations will be available as live events and replays through the investor relations section of Regulus Therapeutics' website. The recordings will be archived for 90 days following each presentation date.
Regulus Therapeutics (Nasdaq: RGLS) reported positive Q2 2024 results and updates for its ADPKD treatment, RGLS8429. Key highlights include:
- Positive topline data from the third cohort of the Phase 1b MAD study
- Advancement to the fourth cohort with 300 mg dosing
- Plans for an End-of-Phase 1 FDA meeting by year-end
- Appointment of Dr. Rekha Garg as Chief Medical Officer
- $95.9 million in cash, extending runway into H1 2026
Financials: R&D expenses increased to $8.3 million, G&A expenses rose to $4.0 million, and net loss was $11.0 million ($0.17 per share) for Q2 2024. The company aims to discuss a potential pivotal Phase 2/3 study under an Accelerated Approval pathway with the FDA.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicines, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The company's management team is scheduled to present on Tuesday, August 13th at 8:30 a.m. ET.
Investors and interested parties can access a replay of the live presentation through the investor relations section of Regulus Therapeutics' website at https://ir.regulusrx.com/events. The replay will be available under the "Events and Presentations" tab and will remain archived for 90 days following the presentation date.
Regulus Therapeutics, a biopharmaceutical firm focusing on microRNA-targeted medicines, announced its participation in two key healthcare investment conferences. The company will present at the H.C. Wainwright Third Annual Kidney Virtual Conference on July 15, 2024, at 10:30 a.m. ET, and later at the JonesHealthcare Seaside Summit at 4:00 p.m. ET the same day. During these events, Regulus will provide a corporate update and share new analyses from the third cohort of its Phase 1b clinical trial of RGLS8429, targeting autosomal dominant polycystic kidney disease (ADPKD). The presentations will be accessible live and as replays on the company's website for 90 days.
Regulus Therapeutics announced positive topline results from the third cohort of its Phase 1b multiple-ascending dose (MAD) clinical trial of RGLS8429 for treating autosomal dominant polycystic kidney disease (ADPKD). The trial evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of RGLS8429 across different doses. Key findings include a significant dose response in urinary biomarkers PC1 and PC2 at 3 mg/kg compared to placebo, and a reduction in total kidney volume in 70% of patients. The drug was well tolerated with no safety concerns. Enrollment for the fourth cohort is underway, with plans for a potentially pivotal Phase 2/3 study under discussion with the FDA.
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.
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