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Is IPF the Next Big Market Opportunity for United Therapeutics?
ZACKS· 2025-10-01 15:41
Key Takeaways United Therapeutics' TETON-2 study showed Tyvaso improved lung function in IPF patients.Benefits were consistent across subgroups, with safety aligning with prior Tyvaso studies.UTHR plans FDA talks this year, with TETON-1 study results expected in early 2026.United Therapeutics (UTHR) remains poised to expand Tyvaso’s label in the respiratory disease space. It recently unveiled results from the late-stage TETON-2 study, which showed clinical benefit in idiopathic pulmonary fibrosis (IPF) pati ...
Phase II and Phase III Catalyst Monitor: Q3 2025 Outlook Report - Upcoming FDA Decisions Drive Momentum in Biopharma with Key Catalysts Across GHD, PKU, Presbyopia, and Wet AMD Treatments
GlobeNewswire News Room· 2025-07-22 14:50
行业动态 - 报告《Catalyst Monitor: Q3 2025 Outlook》提供前瞻性行业洞察,涵盖18项重要催化剂事件,包括临床试验启动、完成、顶线结果、监管申请、PDUFA日期和预期批准 [1] - 报告基于关键意见领袖(KOL)访谈,预测2025年第三季度可能影响市场的重大事件 [3] - 重点关注生物制药行业在2025年第三季度的里程碑事件,包括FDA决定和后期临床试验完成及结果 [7] 公司动态 - Ascendis Pharma的Skytrofa针对成人生长激素缺乏症(GHD)的FDA审批决定 [2] - PTC Therapeutics的sepiapterin针对苯丙酮尿症的审批进展 [2] - Lenz Therapeutics的LNZ100针对老花眼的治疗潜力 [2][7] - Outlook Therapeutics的Lytenava(bevacizumab-vikg)针对湿性年龄相关性黄斑变性(AMD)的审批前景 [2] - Eli Lilly的orforglipron针对肥胖症的持续临床试验 [3] - aTyr Pharma的efzofitimod针对肺结节病的III期EFZO-FIT试验结果 [7] 报告内容 - 报告独家提供II期和III期临床试验结果、监管药物批准等方面的前瞻性见解 [4] - 包含季度催化剂比较,涵盖事件类型、治疗领域、分子类型和公司细分 [7] - 提供催化剂日历,列出2025年第三季度预期发生的重大事件 [7] 涉及公司 - 报告提及多家生物制药公司,包括Wave Life Sciences、Eli Lilly、Ascendis Pharma、PTC Therapeutics、aTyr Pharma、Lenz Therapeutics、Boehringer Ingelheim等 [10]