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 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.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the appointment of Amin Kamel, Ph.D., as Vice President of DMPK, to enhance its clinical development efforts, particularly for RGLS8429, aimed at treating autosomal dominant polycystic kidney disease (ADPKD). Dr. Kamel's previous roles at Takeda and Biogen equip him with extensive expertise. As part of his compensation, he received an option for 200,000 shares at an exercise price of $0.29 per share, vesting over four years. This strategic hire is expected to bolster Regulus's upcoming Phase 1 clinical study.