Regulus Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of drugs targeting microRNAs. Its two lead product candidates, RG-012 and RGLS4326, are in clinical development. RG-012 is an anti-miR targeting miR-21 in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease. RGLS4326 is an anti-miR targeting miR-17 in Phase I clinical trial for the treatment of autosomal dominant polycystic kidney disease. The firm is also developing a pipeline of preclinical drug product candidates in renal, hepatic, and central nervous systems diseases. The company was founded in 2007 and is headquartered in San Diego, CA.
相关临床试验
12
8 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
8
66.7%
已完成
4
33.3%
暂无批准数据
- Novartis has entered a $1.7 billion partnership with Relation Therapeutics to develop treatments for allergic diseases using AI-driven drug discovery platforms that analyze patient datasets and human tissue to identify genetic triggers. - The deal includes $55 million upfront payment with potential milestone payments up to $1.7 billion plus tiered royalties, representing part of Novartis' broader strategy to build a resilient pipeline beyond 2025. - Relation's AI technology aims to nominate genetically validated drug targets faster than traditional discovery methods, potentially improving success rates in a field where roughly 75% of drugs fail in phase 2 trials. - The partnership addresses a significant unmet medical need as atopic diseases affect hundreds of millions of patients worldwide despite heavy R&D investment in the space.
- Novartis agreed to acquire New York-based biotech Tourmaline Bio for $1.4 billion, paying $48 per share in cash, representing a 60% premium to the company's Monday closing price. - The acquisition centers on Tourmaline's lead candidate pacibekitug, an anti-IL-6 IgG2 antibody targeting atherosclerotic cardiovascular disease, which could address a significant unmet medical need. - The deal strengthens Novartis's cardiovascular portfolio as the company faces generic competition for key drugs including top-selling heart medicine Entresto later this year. - The transaction has received board approval from both companies and is expected to close in the fourth quarter of 2025.
- Renasant Bio secured $54.5 million in seed funding from investors including 5AM Ventures, Atlas Venture, OrbiMed and Qiming Venture Partners USA to develop treatments for autosomal dominant polycystic kidney disease (ADPKD). - The company is developing corrector and potentiator therapies inspired by cystic fibrosis treatments, targeting malformed ion channels that cause ADPKD in approximately 12 million people worldwide. - Renasant's lead small molecule corrector candidate is currently in preclinical testing and designed to work across the wide range of mutations that cause ADPKD, with clinical trials planned for the next few years.
- A shareholder lawsuit seeks to block Novartis' acquisition of Regulus Therapeutics, alleging the deal primarily benefits company insiders rather than public stockholders. - The $1.7 billion transaction includes Regulus' lead candidate farabursen for treating the most common inherited kidney disease, with regulatory approval triggering additional payments. - The complaint claims Regulus violated securities laws by omitting critical information about the sales process, conflicts of interest, and financial projections in its recommendation statement. - The acquisition is structured as $7 per share upfront plus contingent value rights of up to $7 per share upon farabursen's regulatory approval.
- Novartis has commenced a tender offer to acquire all outstanding shares of Regulus Therapeutics for $7.00 per share in cash plus one contingent value right per share. - The contingent value rights represent an additional $7.00 payment upon achievement of an unspecified regulatory milestone, potentially doubling shareholder value. - The tender offer expires on June 24, 2025, and Regulus' board of directors has recommended that stockholders accept the offer. - The acquisition is subject to customary conditions including Hart-Scott-Rodino antitrust clearance and requires more than 50% of outstanding shares to be tendered.
- Novartis has agreed to acquire Regulus Therapeutics for $800 million upfront, with potential additional payments of up to $900 million tied to regulatory milestones. - The acquisition centers on farabursen, Regulus' experimental oligonucleotide therapy targeting miR-17 for autosomal dominant polycystic kidney disease (ADPKD), currently in Phase Ib trials. - The deal values Regulus shares at $7 each—a 108% premium over the biotech's closing price—and could ultimately be worth $1.7 billion if all milestones are achieved.
- Pharmaceutical M&A activity is experiencing a significant rebound with major deals including Novartis's $1.7 billion acquisition of Regulus Therapeutics and Merck KGaA's $3.9 billion purchase of SpringWorks Therapeutics. - Small-cap biotechs are becoming prime acquisition targets as 22% of the sector now trades below cash value, the highest level in nine years, creating opportunities for pharma companies with strong balance sheets. - Major pharmaceutical companies including Pfizer, Bristol Myers Squibb, and Sanofi have signaled business development as a top priority, with Pfizer specifically targeting $10-15 billion acquisitions to rebuild its pipeline. - Deal momentum in biotech and pharma sectors rose 63% in Q1 2025 after falling 26% over the previous 12 months, indicating a market recovery despite ongoing tariff concerns.
- DelveInsight's 2025 report reveals a robust pipeline with 75+ companies developing 80+ therapies for chronic kidney disease, highlighting significant industry investment in addressing this growing health concern. - Key late-stage candidates include AstraZeneca's Baxdrostat and Novo Nordisk's Ziltivekimab, targeting different pathways in CKD progression with promising clinical results. - Multiple novel mechanisms are being explored across all development stages, including aldosterone synthase inhibition, anti-inflammatory approaches, and soluble guanylate cyclase activation, expanding potential treatment options.
- New comprehensive report provides critical insights into the global clinical trial landscape for Polycystic Kidney Disease, covering regional distribution, trial phases, and sponsor involvement across G7 and E7 countries. - Major pharmaceutical companies including Otsuka Holdings, Sanofi, and Pfizer are leading clinical development efforts, with the report highlighting prominent drugs currently in various trial phases. - The analysis offers valuable strategic intelligence for stakeholders by tracking enrollment trends, trial statuses, and success rates, enabling more informed investment and research decisions in PKD therapeutics.
- Regulus Therapeutics announced positive topline results from an interim analysis of the Phase 1b MAD study of farabursen for ADPKD. - The study demonstrated a continued mechanistic dose response and a notable reduction in htTKV growth rate in ADPKD patients. - Regulus reached an agreement with the FDA on key components of a Phase 3 single pivotal trial for potential accelerated approval of farabursen. - Farabursen was well-tolerated in the Phase 1b study, reinforcing its potential as a safe treatment option for ADPKD.
