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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 (RGLS) announced significant advancements in its clinical trials for RGLS8429, a treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The first patient has been dosed in the Phase 1b Multiple-Ascending Dose (MAD) study, following positive topline safety and pharmacokinetic results from the Phase 1 Single-Ascending Dose (SAD) study. The company raised $4.5 million in net proceeds through an At-the-Market (ATM) sale to a new institutional investor, bolstering cash resources. As of September 30, 2022, Regulus reported $45.3 million in cash and equivalents.
Regulus Therapeutics Inc. (Nasdaq: RGLS) will report its third quarter 2022 financial results on November 10, 2022, after market close. A live conference call is scheduled for the same day at 5:00 PM ET, where management will discuss the results and provide updates. The call can be accessed via phone or webcast, and replays will be available on the company's website. Regulus focuses on developing innovative medicines targeting microRNAs, with a robust intellectual property in this area.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the dosing of the first patient in the Phase 1b multiple ascending dose (MAD) study of RGLS8429 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This double-blind, placebo-controlled trial will assess RGLS8429's safety, tolerability, and pharmacokinetics in adult patients. The study aims to evaluate treatment effects across three dose levels, with topline data expected in mid-2023. ADPKD affects approximately 160,000 individuals in the U.S., leading to end-stage renal disease in many cases.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a poster presentation at ASN Kidney Week 2022 in Orlando, showcasing data on RGLS8429, a next-generation oligonucleotide targeting microRNAs for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The session will be led by Dr. Edmund Lee on November 3, 2022, highlighting the potential of RGLS8429 to improve kidney function and reduce disease severity based on preclinical studies. ADPKD affects around 160,000 individuals in the U.S. and has a global prevalence of 4 to 7 million.
Regulus Therapeutics has initiated a Phase 1b Multiple Ascending Dose study for RGLS8429 in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The Phase 1 Single Ascending Dose study showed RGLS8429 was well-tolerated with no serious adverse events. Among 32 subjects, only mild adverse events were reported, with one moderate case. The MAD study aims to assess safety and efficacy across different doses, with topline data expected in 1H 2023. RGLS8429 targets microRNAs to improve kidney function, showing promise in preclinical models.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company, announced its participation in two investor conferences. The first is the Wells Fargo Healthcare Conference from September 7-9, 2022 in Boston, MA. The second is the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022 in New York, NY, where CEO Jay Hagan will present on September 12, 2022 at 2:30 p.m. ET. A replay will be available on the company’s website.
Regulus Therapeutics (RGLS) announced significant advancements in the Phase 1 study of RGLS8429 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD), with the first subject dosed. The FDA granted Orphan Drug Designation (ODD) to RGLS8429, enhancing its development potential. Financial results for Q2 2022 showed a net loss of $7.3 million, with $47.5 million in cash reserves. R&D expenses increased to $4.7 million from $4.2 million year-over-year. The company has strengthened its team with the appointment of Dr. Amin Kamel as VP of Drug Metabolism and Pharmacokinetics.
Regulus Therapeutics (Nasdaq: RGLS) announced it will report its second-quarter 2022 financial results on August 11, 2022, after market close. A conference call will be held at 5:00 PM ET the same day to discuss results and provide updates. Interested parties can access the call by dialing (866) 652-5200 for domestic callers. Regulus specializes in the development of medicines targeting microRNAs.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced that the FDA has granted orphan drug designation to RGLS8429 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD), affecting approximately 160,000 Americans. This designation may provide financial incentives and up to seven years of market exclusivity. RGLS8429, designed to inhibit miR-17, has shown promising preclinical results. The company is currently conducting a Phase 1 study to evaluate its safety and pharmacokinetics. The CEO expressed a commitment to improving treatment options for ADPKD patients.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the dosing of the first healthy volunteer in the Phase 1 Single Ascending Dose (SAD) study for RGLS8429, aimed at treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This trial marks a significant milestone in addressing the unmet medical needs of ADPKD patients. The company plans to follow up with a Phase 1b study to further assess RGLS8429's safety, tolerability, and efficacy in patients. ADPKD affects about 160,000 people in the U.S., leading to serious kidney complications in many cases.
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