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) announced that CEO Jay Hagan will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 7:00 a.m. ET. An on-demand webcast will be accessible through the investor relations section of their website and archived for 90 days post-presentation. Regulus focuses on microRNA-targeted biopharmaceuticals and boasts a robust pipeline and intellectual property portfolio in this area. The company, headquartered in San Diego, is navigating various risks, including those presented by the COVID-19 pandemic, which may impact its operations and stock value.
Regulus Therapeutics (RGLS) announced FDA acceptance of the IND for RGLS8429 targeting Autosomal Dominant Polycystic Kidney Disease (ADPKD), with a Phase 1 study set for Q2 2022. The company reported Q1 2022 financial results: cash position at $53.9 million, R&D expenses increased to $3.7 million, and G&A expenses at $2.9 million. Net loss was $6.7 million, or $0.05 per share. Upcoming milestones include top-line data from the healthy volunteer study in H2 2022 and ADPKD patient data in H1 2023.
Regulus Therapeutics Inc (Nasdaq: RGLS) announced that the FDA has accepted its IND application for RGLS8429, a treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). This approval allows the company to move forward with its planned Phase 1 clinical study in healthy volunteers, slated for the second quarter of 2022. The study aims to evaluate the safety and pharmacokinetics of RGLS8429, with subsequent Phase 1b trials to assess its efficacy in ADPKD patients. Regulus anticipates initiating patient dosing in the latter half of 2022.
Regulus Therapeutics Inc. (Nasdaq: RGLS) will report its first quarter 2022 financial results on May 12, 2022, after market close. A live conference call and webcast will be held at 5:00 PM ET the same day to discuss these results and offer a corporate update. Investors can access the call by dialing (866) 652-5200 domestically. Regulus focuses on developing innovative medicines targeting microRNAs and holds a strong intellectual property portfolio in this field.
Regulus Therapeutics (RGLS) has announced the initiation of preclinical studies targeting miR-155 for the treatment of Amyotrophic Lateral Sclerosis (ALS), in collaboration with Brigham and Women's Hospital. This collaboration, established in September 2021, aims to explore the efficacy of miR-155 inhibitors in both in vitro and in vivo models of ALS. Preliminary data is anticipated in the second half of 2022. Research indicates that blocking miR-155 can positively impact ALS progression, highlighting the potential of these compounds as therapeutic candidates for this severe neurodegenerative disease.
Regulus Therapeutics Inc. (Nasdaq: RGLS) reported financial results for the fourth quarter and full year ending December 31, 2021. The company had a net loss of $7.1 million for Q4 and $27.8 million for the year, compared to $1.3 million and $15.7 million in 2020, respectively. Cash and cash equivalents stood at $60.4 million at year-end. Significant progress was made in their ADPKD program with RGLS8429, having completed a Pre-IND meeting with the FDA. The company closed a $34.6 million private placement in November 2021 to support clinical development activities.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a conference call to discuss its fourth quarter and year-end 2021 financial results, scheduled for March 10, 2022, at 5:00 PM ET. Subsequently, management will provide updates on its developments, including its RGLS8429 program. Regulus emphasizes its focus on innovative medicines targeting microRNAs while cautioning that forward-looking statements about clinical studies and potential impacts from COVID-19 may vary from actual results. Access details for the live call and a replay option post-event are provided.
Regulus Therapeutics Inc. (Nasdaq: RGLS) has completed enrollment in the Phase 2 HERA clinical trial for lademirsen, targeting Alport Syndrome, a genetic nephrology disease with no current treatments. Under a partnership with Sanofi, the study will evaluate safety and efficacy in adult patients. Final results are anticipated in the first half of 2023. Regulus is eligible for up to $35 million in milestone payments from Sanofi, with $10 million already received for prior achievements. This trial represents a significant step in developing treatments for kidney diseases.
Regulus Therapeutics Inc (Nasdaq: RGLS) announced that its CEO, Jay Hagan, will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 3:00 p.m. ET. A live webcast of the event will be available on the investor relations section of the Company's website, with a replay accessible for 90 days post-event. Regulus focuses on developing innovative medicines targeting microRNAs and possesses a robust intellectual property portfolio in this field, headquartered in San Diego, CA.
Regulus Therapeutics (Nasdaq: RGLS) announced the successful completion of a pre-investigational new drug (Pre-IND) meeting with the FDA regarding its compound RGLS8429, aimed at treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The FDA approved the trial design and dosing plan, allowing Regulus to submit an IND application in Q2 2022 for a Phase 1 clinical trial. The study will assess the drug's safety, tolerability, and dose response in healthy volunteers and ADPKD patients, with expected data releases in 2022 and 2023. The company also secured $34.6 million in funding to support this clinical development.
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