Basel, June 25, 2025 – Novartis today announced that it has successfully completed its acquisition of Regulus Therapeutics Inc. (“Regulus”). With the completion of the acquisition, shares of common stock, par value $0.001 per share (the “Shares”), of Regulus, have ceased trading on the Nasdaq Stock Market LLC and Regulus is now an indirect wholly owned subsidiary of Novartis. “We are pleased to complete this transaction and take the next step in advancing clinical development for a potential first-in-class ...

Basel, June 25, 2025 – Novartis today announced that its previously announced tender offer (the “Offer”) by Redwood Merger Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Novartis (“Purchaser”), to acquire all of the outstanding shares of common stock, par value $0.001 per share (the “Shares”), of Regulus Therapeutics Inc. (“Regulus”), in exchange for (i) $7.00 in cash per share, subject to any applicable withholding and without interest thereon, plus (ii) one contingent value ri ...

Core Points - Novartis announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act in relation to its tender offer to acquire Regulus Therapeutics Inc. [1][2] - The tender offer includes $7.00 in cash per share and one contingent value right (CVR) per share, which represents the right to receive an additional $7.00 upon achieving a regulatory milestone [1][2]. - The expiration of the HSR Act waiting period is a necessary condition for the completion of the merger agreement dated April 29, 2025 [2]. Tender Offer Details - The offer will expire one minute past 11:59 p.m. New York City Time on June 24, 2025, unless extended or terminated earlier [2]. - The completion of the transaction requires validly tendered shares that, along with shares owned by Novartis and its subsidiaries, represent at least one more than 50% of the total outstanding shares [2]. Additional Information - Novartis and its subsidiary filed a tender offer statement with the U.S. Securities and Exchange Commission (SEC), and Regulus filed a solicitation/recommendation statement regarding the tender offer [3]. - Investors are encouraged to read the tender offer materials and the solicitation/recommendation statement for important information before making decisions [4].

Entered into an agreement to be acquired by Novartis for $7.00 per share in cash, with potential to receive an additional $7.00 per share in cash through a contingent value right ("CVR") upon the achievement of a regulatory milestone, for a total equity value of up to approximately $1.7 billion; Expected to be completed in the second half of 2025, subject to customary closing conditionsPositive topline data from the completed fourth cohort of patients in the Phase 1b multiple-ascending dose (MAD) study of f ...

智通财经APP获悉，诺华制药(NVS.US)周三发布声明称，已达成协议将收购美国生物技术公司Regulus Therapeutics Inc.(RGLS.US)，这笔交易最高价值可达17亿美元。报告显示，这家瑞士制药巨头将通过一 家子公司，以每股7美元的价格预付总计8亿美元现金。 受此消息影响，Regulus Therapeutics股价在周三美股盘前飙升，截至发稿，上涨134%。同日，诺华股 票在瑞士市场表现平稳，不过在过去12个月里，其股价已累计上涨近6%。 此外，Regulus Therapeutics的股东还将获得一项或有价值权(CVR)——如果用于治疗常染色体显性多囊 肾病(ADPKD，这是导致肾衰竭最常见的遗传病因)的药物farabursen获得监管批准，他们还可额外获得9 亿美元。 目前，这笔收购交易已获得双方董事会批准，预计将于2025年下半年完成。 诺华首席财务官哈里·基尔希本周表示，公司正在积极寻求并购机会，希望借此在2025年后提升销售额; 同时他也指出，生物技术领域的企业估值正呈现下行趋势。 Regulus Therapeutics专注于研发靶向微小核糖核酸(microRNA)的疗法， ...

Regulus is a clinical-stage biopharmaceutical company developing microRNA therapeutics with a focus on autosomal dominant polycystic kidney disease (ADPKD), a severe renal diseaseLead asset for ADPKD, farabursen, is a novel, next-generation oligonucleotide targeting miR-17 that recently completed a Phase 1b multiple-ascending dose clinical trial Transaction includes USD 0.8 billion upfront with a potential additional USD 0.9 billion payment upon the achievement of a future regulatory milestone; transaction ...

Core Insights - Regulus Therapeutics announced positive topline results from the fourth cohort of its Phase 1b MAD study of farabursen for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD) [2][4] - The study demonstrated a significant halting of kidney volume growth in patients receiving a 300 mg fixed dose of farabursen over four months [1][4] - The company is on track to initiate a Phase 3 pivotal trial in Q3 2025, with a focus on a 12-month endpoint for kidney volume change [2][6] Study Details - The Phase 1b MAD study was a double-blind, placebo-controlled trial assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of farabursen in adult ADPKD patients [3] - The study included three weight-based dose levels and one fixed dose level, with primary endpoints focused on urinary PC1 and PC2 changes, and an exploratory examination of htTKV growth rate [3][4] - In the fourth cohort, 26 subjects received 300 mg of farabursen bi-weekly for three months, showing consistent mechanistic responses and halting htTKV growth [4][5] Efficacy and Safety - Patients treated with farabursen showed a mean htTKV growth rate of 0.05%, compared to 2.58% in placebo subjects, indicating a significant reduction in kidney volume growth [5] - Urinary levels of PC1 and PC2 increased significantly, correlating with the observed effects on kidney volume [5] - Farabursen demonstrated a favorable safety and tolerability profile, consistent with earlier cohorts, with no serious adverse events reported [5][9] Future Plans - The company has confirmed alignment with the FDA regarding the Phase 3 trial design, which includes a 12-month htTKV endpoint for Accelerated Approval and a 24-month eGFR endpoint for Full Approval [6][9] - Regulus aims to advance farabursen as a potential treatment option for ADPKD, addressing a significant unmet medical need [6][10] Background on ADPKD - ADPKD is a common genetic disorder characterized by the development of multiple cysts in the kidneys, leading to end-stage renal disease in approximately 50% of patients by age 60 [8] - The disease affects around 160,000 individuals in the U.S., with a global prevalence estimated between 4 to 7 million [8]