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.
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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.
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.