Mineralys Therapeutics(MLYS)

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Mineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM)
GlobeNewswire· 2025-04-24 05:23
– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of dysregulated aldosterone in disease onset and progression – – Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication – RADNOR, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focu ...
Mineralys Therapeutics to Host KOL Call to Discuss Clinical Data from Launch-HTN and Advance-HTN Pivotal Trials Tuesday, April 1, 2025, at 8:00 AM ET
Newsfilter· 2025-03-25 20:00
RADNOR, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will host a conference call and webinar featuring Dr. Luke Laffin of the Cleveland Clinic, who will discuss the latest results from the pivotal Advance-HTN and Launch-HTN clinical trials, ...
Mineralys Therapeutics Announces Closing of Underwriters' Option to Purchase Additional Shares in Connection with Public Offering of Common Stock
GlobeNewswire News Room· 2025-03-19 04:01
文章核心观点 - Mineralys Therapeutics完成额外股票出售,获约2.012亿美元毛收入,将用于产品临床开发等 [1][2] 公司概况 - Mineralys Therapeutics是临床阶段生物制药公司,专注开发治疗高血压、慢性肾病、阻塞性睡眠呼吸暂停等疾病药物,初始候选产品为lorundrostat [5] 股票发行情况 - 公司完成额外1944444股普通股出售,每股公开发行价13.50美元,发行总毛收入约2.012亿美元,所有证券均由公司出售 [1] - BofA Securities等担任联合账簿管理人,LifeSci Capital担任牵头管理人,H.C. Wainwright & Co.担任联合管理人 [2] 资金用途 - 公司打算用发行净收入资助lorundrostat临床开发、研发和制造、商业化前活动,以及用作营运资金和一般公司用途 [2] 招股文件获取方式 - 可从BofA Securities等机构获取最终招股说明书补充文件和随附招股说明书,也可在SEC网站获取电子版 [3] 联系方式 - 投资者关系联系邮箱为investorrelations@mineralystx.com [8] - 媒体关系联系人是Tom Weible,电话(1) 515 - 707 - 9678,邮箱tweible@elixirhealthpr.com [8]
Mineralys Therapeutics Announces Data from the Phase 2 Advance-HTN Trial of Lorundrosat for the Treatment of Hypertension Has Been Accepted as a Late-Breaking Presentation at the 2025 American College of Cardiology's Annual Scientific Session & Expo
GlobeNewswire News Room· 2025-03-17 20:00
RADNOR, Pa., March 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea and other diseases driven by dysregulated aldosterone, today announced that data from the Phase 2 Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be pres ...
Mineralys Therapeutics Announces Pricing of $175.0 Million Underwritten Public Offering of Common Stock
GlobeNewswire News Room· 2025-03-12 10:20
RADNOR, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the pricing of an underwritten public offering of 12,962,962 shares of its common stock at a public offering price of $13.50 per share. The aggregate gross proceeds to Mineralys from the of ...
Mineralys: Prospects Just Got Better With Successful Pivotal Data Readouts
Seeking Alpha· 2025-03-11 06:25
文章核心观点 介绍Biotech Analysis Central服务及Mineralys Therapeutics相关文章情况 [1][2] 服务信息 - Biotech Analysis Central服务由Terry Chrisomalis运营 提供多家制药公司深度分析 [1] - 该服务在Seeking Alpha Marketplace平台每月收费49美元 年度订阅有33.50%折扣 每年399美元 现提供两周免费试用 [1] - Biotech Analysis Central投资组有600多篇生物技术投资文章 10多只中小盘股的模型投资组合及详细分析 还有实时聊天及一系列分析和新闻报道 帮助医疗保健投资者决策 [2] 公司相关 - 曾写过关于Mineralys Therapeutics的文章《Mineralys: 2nd Half 2024 Hypertension Data Readout》 [2]
Mineralys Therapeutics Announces Proposed Public Offering of Common Stock
GlobeNewswire News Room· 2025-03-11 04:01
文章核心观点 - 临床阶段生物制药公司Mineralys Therapeutics宣布开展2.5亿美元普通股包销公开发行,还可能授予承销商30天选择权额外购买3750万美元普通股,所得款项用于产品临床开发等 [1] 公司概况 - Mineralys Therapeutics是临床阶段生物制药公司,专注开发治疗高血压、慢性肾病、阻塞性睡眠呼吸暂停等疾病药物,初始候选产品为lorundrostat,公司位于宾夕法尼亚州拉登诺,由Catalys Pacific创立 [6] 发行情况 - 公司开展2.5亿美元普通股包销公开发行,预计授予承销商30天选择权额外购买3750万美元普通股,所有待售证券由公司出售,发行受市场等条件限制 [1] 承销团队 - BofA Securities、Evercore ISI、Goldman Sachs & Co. LLC、Stifel和Wells Fargo Securities担任联合账簿管理人,LifeSci Capital担任牵头管理人,H.C. Wainwright & Co.担任联合管理人 [2] 资金用途 - 公司拟将发行所得净收益用于lorundrostat临床开发、研发和制造、商业化前活动,以及营运资金和一般公司用途 [3] 文件获取 - 发行相关初步招股说明书补充文件和随附招股说明书将提交美国证券交易委员会,可从各承销商处获取,电子副本也可在SEC网站获取 [4] 联系方式 - 投资者关系联系邮箱为investorrelations@mineralystx.com,媒体关系联系人是Tom Weible,电话(1) 515 - 707 - 9678,邮箱tweible@elixirhealthpr.com [9]
Mineralys Therapeutics Unveils Positive Data From Two Trials For Hypertension Drug Candidate
Benzinga· 2025-03-11 01:50
On Monday, Mineralys Therapeutics, Inc. MLYS released topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials of lorundrostat for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).Both trials achieved statistical significance, were clinically meaningful in their prespecified primary efficacy endpoints, and demonstrated a favorable safety and tolerability profile.The Launch-HTN trial met the primary endpoint with lorundrostat 50 mg dose achieved a 16.9 mmHg red ...
Mineralys Therapeutics Announces Positive Topline Results from Launch-HTN and Advance-HTN Pivotal Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension
Newsfilter· 2025-03-10 19:00
– Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 –– Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at end of treatment, week 12 –– Ad ...
Mineralys Therapeutics to Announce Topline Data from Launch-HTN and Advance-HTN Pivotal Trials Monday, March 10, 2025, at 8:00 AM ET
Newsfilter· 2025-03-08 05:01
文章核心观点 - 临床阶段生物制药公司Mineralys Therapeutics宣布将于2025年3月10日上午8点举办电话会议和网络研讨会,公布Launch - HTN和Advance - HTN关键试验的 topline 结果 [1] 公司信息 - Mineralys Therapeutics是专注于开发治疗高血压、慢性肾病、阻塞性睡眠呼吸暂停等由醛固酮失调引起疾病药物的临床阶段生物制药公司,总部位于宾夕法尼亚州拉德诺,由Catalys Pacific创立 [1][5] - 公司初始候选产品lorundrostat是一种专有的、口服的、高选择性醛固酮合酶抑制剂,正被开发用于受醛固酮失调影响的心脏肾脏疾病 [5] 试验信息 - Launch - HTN试验评估了lorundrostat作为现有2至5种降压药物背景治疗的附加疗法,治疗未控制高血压或难治性高血压的疗效和安全性 [2] - Advance - HTN试验评估了lorundrostat作为2至3种标准化降压药物背景治疗的附加疗法,治疗未控制高血压或难治性高血压的疗效和安全性 [3] 会议信息 - 会议时间为2025年3月10日上午8点(美国东部时间) [1][4] - 国内拨打1 - 877 - 704 - 4453,国际拨打1 - 201 - 389 - 0920,也可在公司网站投资者关系板块的“新闻与活动”页面观看网络直播 [4] 联系方式 - 投资者关系联系邮箱为investorrelations@mineralystx.com [6] - 媒体关系联系人是Tom Weible,电话(1) 515 - 707 - 9678,邮箱tweible@elixirhealthpr.com [6]