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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 Inc. (Nasdaq: RGLS) announced a private placement to institutional and accredited investors, aiming to raise approximately $15.0 million. The financing is led by the Federated Hermes Kaufmann Funds and New Enterprise Associates, with completion expected on April 13, 2023. Investors will purchase 2,615,536 shares of common stock at $0.9001 per share and 140,827 shares of non-voting Class A-5 convertible preferred stock for $90.01 per share, convertible to 100 shares of common stock. The offering is not registered under the Securities Act of 1933, thus limiting resale in the U.S. without proper registration. Regulus focuses on innovative microRNA medicines, emphasizing its commitment to drug discovery and development.
Regulus Therapeutics Inc. (Nasdaq: RGLS) has successfully completed enrollment in the first cohort of its Phase 1b multiple ascending dose (MAD) clinical trial for RGLS8429, aimed at treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). This trial evaluates the drug's safety, tolerability, and pharmacokinetics in adults diagnosed with ADPKD. Topline data is anticipated by Q3 2023. The first cohort will receive RGLS8429 at a dose of 1 mg/kg every other week for three months. Following safety reviews, a second cohort will commence with a 2 mg/kg dosing regime. RGLS8429, designed to inhibit miR-17, has shown promising preclinical results, indicating improvements in kidney function and other disease metrics. ADPKD affects roughly 160,000 people in the U.S. and 4 to 7 million globally, making this research particularly significant.
Regulus Therapeutics (RGLS) provided an update on its clinical progress and financial results for 2022. The Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 for Autosomal Dominant Polycystic Kidney Disease (ADPKD) is underway, with top-line data expected in the second half of 2023. The company reported a net loss of $28.3 million for the year, equating to $1.86 per share, on increased R&D expenses of $18.4 million. As of December 31, 2022, Regulus had $39.2 million in cash. Key leadership appointments were made to bolster clinical development operations.
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company, announced that its President and CEO, Jay Hagan, will present at the SVB Securities Global Biopharma Conference on February 16, 2023, at 1:00 p.m. ET. The company focuses on discovering and developing innovative medicines targeting microRNAs. A replay of the presentation will be available for 30 days on the company's investor relations website. Regulus has built a strong pipeline and intellectual property portfolio in the microRNA field. Forward-looking statements in the press release highlight potential risks and uncertainties affecting the company’s drug development programs.
On January 13, 2023, Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the grant of inducement stock options to Dr. Claire Padgett and Dr. Rekha Garg upon their appointments as Senior Vice Presidents. Each received an option to purchase 120,000 shares at an exercise price of $1.48 per share. The options have a 10-year term and will vest over four years, starting with 25% vesting on December 1, 2023. This grant aligns with NASDAQ Listing Rule 5635(c)(4) and is considered material to their employment acceptance. Regulus focuses on developing medicines targeting microRNAs and holds a robust intellectual property portfolio.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the resignation of Simos Simeonidis from its Board of Directors, effective December 6, 2022. His departure is attributed to his new role as co-CEO and co-CIO at Ally Bridge Group. The Board expressed gratitude for his leadership, noting his significant contributions to the company's strategic direction. Regulus specializes in developing innovative medicines targeting microRNAs and is advancing the clinical development of RGLS8429 for treating ADPKD. The company emphasized its commitment to long-term success despite the leadership change.
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced key appointments to its leadership team, including Rekha Garg, M.D., and Claire Padgett, Ph.D., as Senior Vice Presidents for Clinical Development and Clinical Operations, respectively. Both have been instrumental in advancing the Phase 1 clinical program for RGLS8429, targeting ADPKD. Additionally, Morgan Carlson, Ph.D., and Edmund Lee, Ph.D., received promotions to Vice Presidents, recognizing their contributions to biomarker strategy. The company expressed gratitude to Denis Drygin, Ph.D., who has stepped down as Chief Scientific Officer.
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