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About Regulus Therapeutics Inc.
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a pioneering biopharmaceutical company dedicated to the discovery and development of innovative medicines targeting microRNAs (miRNAs). With headquarters in San Diego, California, Regulus has established itself as a leader in the miRNA field by leveraging its proprietary oligonucleotide drug discovery platform and a strong intellectual property portfolio. The company’s mission is to address unmet medical needs in complex diseases by modulating miRNA pathways, a novel approach in the pharmaceutical industry.
Core Expertise and Therapeutic Focus
Regulus specializes in developing miRNA-based therapeutics, which offer a unique mechanism of action by targeting the regulatory functions of miRNAs in various biological pathways. This innovative approach allows Regulus to address diseases at their genetic and molecular roots, providing potential solutions for conditions that currently lack effective treatments. The company's expertise in oligonucleotide chemistry and biology underpins its ability to design and develop next-generation therapies with high specificity and efficacy.
Pipeline and Key Programs
Regulus' lead product candidate, RGLS8429 (also known as farabursen), is a next-generation oligonucleotide therapy designed to inhibit miR-17 and preferentially target kidney tissues. This drug is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), a genetic disorder characterized by the formation of fluid-filled cysts in the kidneys, leading to progressive kidney failure. ADPKD affects millions globally and has limited therapeutic options, making RGLS8429 a potential game-changer in nephrology.
RGLS8429 has demonstrated promising results in preclinical studies and early-phase clinical trials. The company has completed multiple cohorts in its Phase 1b Multiple Ascending Dose (MAD) study, showing dose-dependent increases in urinary polycystin levels (PC1 and PC2), reductions in height-adjusted total kidney volume (htTKV), and a favorable safety profile. These biomarkers are critical indicators of disease severity and progression in ADPKD.
Strategic Collaborations and Intellectual Property
Regulus has strategically aligned itself with leading academic and industry partners to enhance its research and development capabilities. Notable collaborations include a partnership with The University of Texas Southwestern Medical Center for intellectual property related to miR-17 targeting in ADPKD. The company also maintains a rich portfolio of patents and proprietary technologies, reinforcing its leadership in the miRNA therapeutics space.
Market Significance
The biopharmaceutical industry is increasingly recognizing the potential of miRNA-targeting therapies, and Regulus stands out as a key innovator in this niche. By focusing on diseases like ADPKD, which have high unmet medical needs and limited competition, Regulus is well-positioned to make a significant impact. Its advancements in miRNA biology not only pave the way for new treatments but also set a precedent for future therapeutic development in this emerging field.
Challenges and Opportunities
Regulus faces challenges typical of early-stage biopharmaceutical companies, including the need for substantial capital to fund its R&D activities and the complexities of navigating regulatory pathways. However, its robust clinical data, strategic partnerships, and focus on high-value therapeutic areas provide a strong foundation for growth and innovation.
Conclusion
Regulus Therapeutics Inc. exemplifies innovation in the biopharmaceutical industry through its focus on miRNA-targeting therapies. With a promising pipeline led by RGLS8429 for ADPKD, the company is addressing critical gaps in medical treatment while advancing the field of genetic and molecular therapeutics. Regulus' expertise, strategic collaborations, and commitment to scientific excellence position it as a noteworthy player in the quest to develop transformative medicines for complex diseases.
Regulus Therapeutics (Nasdaq: RGLS) reported its Q3 2021 financial results on November 10, 2021. The company had $35.8 million in cash as of September 30, 2021, with net losses of $8.6 million for the quarter. Regulus is focusing on the development of RGLS8429 for ADPKD, having discontinued RGLS4326 due to its limitations. A pre-IND meeting with the FDA is expected in December 2021, with clinical development anticipated in Q2 2022. The company reported increased R&D expenses of $5.9 million for the quarter, up from $4.0 million the previous year.
Regulus Therapeutics Inc. (RGLS) announced it will report its financial results for Q3 2021 on November 10, 2021, after market close. A conference call and webcast will also be held on the same day at 5:00 PM EDT. The call can be accessed domestically at (877) 257-8599 or internationally at (970) 315-0459, with a replay option available. The company focuses on microRNA-targeted medicines and notes potential risks affecting its business, including impacts from the COVID-19 pandemic.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced a strategic focus on RGLS8429 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). Following the completion of IND-enabling toxicity studies, the firm plans to submit an Investigational New Drug (IND) application and has scheduled a Phase 1 study in Q2 2022, subject to FDA approval. The decision stems from recent data suggesting RGLS8429's improved pharmacological profile and absence of negative CNS effects previously seen with RGLS4326. Initial biomarker data is expected in early 2023.
Regulus Therapeutics (Nasdaq: RGLS) announced that its director, David Baltimore, Ph.D., received the 2021 Lasker-Koshland Special Achievement Award for his significant contributions to virology, immunology, and cancer. This prestigious award celebrates advances in medical science and highlights the importance of public support for research. The CEO, Jay Hagan, praised Dr. Baltimore's extensive work and its influence on biotechnology and public health, including his role during the AIDS crisis. Regulus continues to benefit from his guidance in advancing its pipeline of microRNA therapeutics.
Regulus Therapeutics (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA therapeutics, announced that its CEO, Jay Hagan, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 a.m. ET. The presentation will be accessible via an on-demand webcast available on their investor relations website. A replay will be archived for 30 days. Regulus focuses on developing innovative medicines and holds a strong intellectual property portfolio in the microRNA sector.
Regulus Therapeutics (Nasdaq: RGLS) reported its Q2 2021 financial results and key program developments, emphasizing progress in its ADPKD treatment program. Notably, the second cohort in the Phase 1b trial of RGLS4326 has been enrolled, with topline data expected soon. Financially, Regulus raised $15.4 million through an ATM facility and had $41.4 million in cash as of June 30, 2021. The net loss was $6.0 million for the quarter, improving from $6.9 million in the previous year. The company plans to discuss remaining clinical hold requirements with the FDA.
Regulus Therapeutics (Nasdaq: RGLS) will announce its financial results for Q2 2021 on August 10, 2021, after market close. The company will host a conference call at 5:00 PM ET on the same day to discuss the results and provide corporate updates. CEO Jay Hagan will also speak at the Wedbush PacGrow Healthcare Conference on August 11, 2021. Regulus focuses on developing innovative medicines targeting microRNAs and emphasizes its drug discovery expertise and intellectual property in this field. The release mentions forward-looking statements subject to various risks and uncertainties.
Regulus Therapeutics (Nasdaq: RGLS) announced new data from its Phase 1b clinical trial of RGLS4326 for treating autosomal dominant polycystic kidney disease (ADPKD) during the PKD Connect Conference 2021. The results indicate significant target engagement in kidneys, with increased urinary biomarkers PC1 and PC2, correlating inversely with disease severity. RGLS4326 was well-tolerated, showing no serious adverse events. Preclinical data demonstrated improved gene expression and kidney function in animal models. The trial is ongoing with further cohorts being enrolled.
Regulus Therapeutics (Nasdaq: RGLS) announced its presentation of new preclinical and clinical data on RGLS4326 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This will take place at the PKD Connect Conference on June 25, 2021. The Phase 1b trial aims to evaluate safety and efficacy across three patient cohorts, utilizing specific dosing regimens. Jay Hagan, CEO, emphasized the significance of sharing data that supports miR-17 as a therapeutic target. RGLS4326, targeting kidney microRNAs, shows promise in mitigating cyst growth and enhancing kidney function.
Regulus Therapeutics Inc. (Nasdaq: RGLS) provided an update on its Phase 1b clinical trial of RGLS4326 for patients with autosomal dominant polycystic kidney disease (ADPKD). Nine patients in the first cohort received 1 mg/kg doses every other week, leading to a mean increase in polycystin levels of 58% for PKD1 and 38% for PKD2, both statistically significant (p=.0004 and p=.026). The treatment was well-tolerated with no serious adverse events. Regulus plans to present further data at upcoming conferences, with the next cohort results expected in Q3 2021.
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