Sep 12, 2025 7:00 AM Eastern Daylight Time United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at the European Respiratory Society Congress Share Results of the successful phase 3 TETON-2 study of inhaled treprostinil in idiopathic pulmonary fibrosis will be presented in an oral presentation SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent rese ...

United Therapeutics Has Near-Perfect Composite Rating Decades of market research reveals that the market's biggest winners tend to have an RS Rating above 80 as they launch their biggest runs. Among its other key ratings United Therapeutics carries an 84 EPS Rating out of 99. It also boasts a terrific 96 Composite Rating. The Composite score combines five separate proprietary ratings into one. The best growth stocks have a Composite Rating of 90 or better. Additionally, it has a best-possible SMR Rating (sa ...

PresentationTerence FlynnEquity Analyst All right. Great. Thanks. I think we're going to get started here, but I'm Terence Flynn, the U.S. biopharma analyst at Morgan Stanley. Very pleased to be hosting United Therapeutics this afternoon. Today from the company, we have James Edgemond, the company's CFO and Treasurer; and Harry Silvers, Investor Relations team. Thank you both so much for being here. Just before we get started, for important disclosures, please see the Morgan Stanley research disclosure webs ...

**公司 United Therapeutics (UTHR) 电话会议纪要关键要点** **1 公司业务与核心产品** - 公司专注于罕见肺部疾病、心肺疾病和肿瘤学领域 重点关注内部研发和设施投资[27] - 核心产品Tyvaso（曲前列尼尔）用于治疗肺动脉高压（PAH）和间质性肺病（ILD） 近期在特发性肺纤维化（IPF）适应症上取得突破[2][3][30] - 拥有异种移植项目（xenotransplant） 包括U-kidney和thymokidney产品 目前处于临床阶段[42][46] **2 Teton临床项目与IPF适应症进展** - Teton项目包括Teton 1和Teton 2两项临床试验 Teton 2针对美国和加拿大市场 已公布阳性结果 Teton 1预计2026年上半年读出数据[6][8] - Teton 2试验中 雾化Tyvaso在IPF患者中显示绝对FVC（用力肺活量）较基线改善95.6毫升（p值<0.0001） 且与标准疗法联用效果更佳[3] - 公司已获得FDA和EMA授予的IPF适应症孤儿药资格 预计在IPF市场拥有长期独占期[4] - 计划2025年下半年与FDA会议 探讨基于Teton 2单一研究加速提交sNDA（补充新药申请）的可能性[10] **3 商业机会与市场策略** - IPF美国患者约10万人 市场潜力达数十亿美元 公司计划组建独立的IPF/ILD销售团队[15][16][20] - 当前增长驱动来自PAH/ILD适应症和Tyvaso DPI（干粉吸入剂）的持续放量[30] - 针对竞争对手Utrepia（Liquidi） 公司强调Tyvaso DPI的优势：无最大剂量限制、耐受性随时间改善、颗粒尺寸优化、每日四次给药无需清洁设备[31][32] - 2025年已完成2026年医保合同谈判 旨在确保Tyvaso与竞品处于同等报销地位 目前无需额外合同调整[40] **4 资本配置与财务策略** - 资本配置优先级：内部研发与设施投资、企业发展、股东回报[25] - 2025年8月启动10亿美元加速股票回购计划 反映对公司商业实力、资产负债表和股价潜力的信心[26] - 不提供具体收入指引 但预计现有商业业务将实现两位数收入增长[29] **5 异种移植项目进展与产能规划** - EXPAND研究（首个人体移植试验）即将启动 预计首例患者移植在短期内进行[42] - 目前运营弗吉尼亚州Christiansburg设施（已通过FDA检查） 正在建设明尼苏达州和德克萨斯州新设施 每个设施年产能约125个器官[46][54] - 放弃原10-20亿美元大型设施计划 转向多个小型设施（单设施投资约数亿美元）以实现地理分散和灵活扩产[50][51] - 目标人群为50万透析但不符肾移植条件的患者 商业机会取决于器官供应能力[45] **6 其他重要信息** - 治疗持续时间：IPF预期与PAH/ILD相似 但需更多数据确认[24] - 竞争对手WinRevare（细胞毒性疗法）可能提前至二线治疗 但公司认为不影响Tyvaso长期使用（因疾病进展仍需联合治疗）[34][35] - 异种移植数据披露策略未定 但将比此前医院主导的紧急使用IND更严谨[44]

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Key Takeaways United Therapeutics surged 33% after positive results from the TETON-2 Tyvaso study in IPF.Tyvaso showed superiority over placebo in lung function after 52 weeks with consistent safety.UTHR aims to expedite review by meeting the FDA this year ahead of TETON-1 results in 2026.Shares of United Therapeutics (UTHR) surged 33% on Tuesday after it announced positive top-line results from the late-stage TETON-2 study evaluating the nebulized version of Tyvaso (treprostinil) in adult patients with idi ...

CANADA - 2025/06/10: In this photo illustration, the United Therapeutics Corporation logo is seen displayed on a smartphone. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty Images United Therapeutics' stock (NASDAQ: UTHR) surged 33% on September 2nd after the company announced positive late-stage clinical trial results for Tyvaso (treprostinil) Inhalation Solution in idiopathic pulmonary fibrosis (IPF). The trial met its primary endpoint, and t ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

核心临床研究结果 - TETON-2研究达到主要疗效终点 与安慰剂相比绝对用力肺活量改善95.6毫升[1] - 在所有亚组中均观察到Tyvaso获益 包括背景治疗使用情况、吸烟状态和补充氧气使用[2] - 多数次要终点显示统计学显著改善 包括首次临床恶化事件时间、预测FVC百分比变化、K-BILD生活质量问卷和DLCO[3] - 首次IPF急性加重时间和52周总生存期虽未达统计显著性 但呈现有利于Tyvaso的趋势[4] - 治疗耐受性良好 安全性与既往研究一致 未发现新的安全信号[4] 监管申请与后续计划 - 公司拟结合TETON-2和正在进行中的TETON-1研究数据 向FDA提交补充新药申请以扩大标签适应症至IPF[5] - 计划2024年底前与FDA会晤 讨论加速审评流程的可行性[5] - TETON-1研究数据预计2026年上半年公布[5] 财务表现与市场反应 - 公司销售额达7.986亿美元 同比增长12%[6] - Tyvaso DPI收入3.15亿美元 同比增长22%[6] - 雾化Tyvaso、Orenitram和Unituxin均实现两位数收入增长[6] - 股价单日上涨41.09%至430美元[6]

合作与协议 - 联合治疗公司行使选择权 与曼恩凯德公司扩大合作 共同开发第二款干粉吸入疗法[1] - 此次合作基于双方2018年达成的许可与合作协议 该协议曾促成Tyvaso DPI在2022年5月获得美国FDA批准[2] - 曼恩凯德将使用其专有Technosphere平台配制第二个研究分子 联合治疗负责临床前和临床开发工作[2] 财务条款 - 曼恩凯德将获得500万美元首付款 并有资格获得高达3500万美元的开发里程碑付款[3] - 公司还将获得任何最终产品净销售额10%的特许权使用费[3] 技术平台与产品 - Technosphere是曼恩凯德的专有干粉制剂平台 可实现药物快速便捷地输送至肺部深处[6] - 公司专注于开发创新吸入治疗产品和设备 针对内分泌和罕见肺部疾病的未满足医疗需求[5] - 技术平台可使药物在肺部局部发挥作用或进入体循环 具体取决于目标适应症[6] 战略意义与管理层评论 - 此次合作建立在Tyvaso DPI成功基础上 Tyvaso DPI是FDA批准的首个治疗肺动脉高压的干粉吸入疗法[1][3] - 公司首席执行官强调合作彰显了合作伙伴关系的实力及干粉制剂和吸入装置在治疗严重呼吸系统疾病方面的多功能性[3] - 新研究分子的制剂和开发活动将立即开始[4] 公司背景 - 曼恩凯德致力于利用其制剂能力和设备工程技术 减轻糖尿病、非结核分枝杆菌肺病、肺纤维化和肺动脉高压等疾病负担[6] - 公司通过全国范围内的专业团队合作 致力于让人们掌控健康并获得生活自由[7]