LOS ANGELES, Sept. 16, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Summit Therapeutics Inc. investors  ("Summit" or the "Company") (NASDAQ: SMMT) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors.  Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: lesley@portnoylaw.com, to discuss their legal rights, or join the case via https://portnoylaw.com/summit-therapeutics-in ...

U.S. stock futures are showing modest gains this Tuesday, September 16, 2025, as investors eagerly await the Federal Reserve's crucial policy decision, expected to include an interest rate cut. The positive sentiment is largely a carryover from Monday's record-setting session for technology-heavy indexes and renewed optimism surrounding U.S.-China trade relations. Premarket indicators suggest a cautious but upward trend as market participants digest a slew of economic data and corporate news before the open ...

法律调查事件 - Pomerantz LLP正在调查Summit Therapeutics Inc 是否涉及证券欺诈或其他非法商业行为 [1] 临床实验结果 - 2025年5月30日公司公布ivonescimab联合化疗的三期临床研究HARMONi顶线结果 显示治疗组疾病进展或死亡风险降低48% 但未达到总生存期的主要终点统计学显著性 [3] - 2025年9月7日公司补充发布试验数据 显示ivonescimab在北美和欧洲患者中的疗效表现弱于其他地区患者 [4] 股价波动 - 2025年5月30日临床数据公布后 公司股价单日下跌7.99美元 跌幅达30.5% 收盘报18.22美元 [4] - 2025年9月8日地区疗效差异数据披露后 公司股价单日下跌6.54美元 跌幅达25.15% 收盘报19.45美元 [4]

Summit Therapeutics Inc. (NASDAQ:SMMT) is one of the Best Stocks to Buy for the Next 3 Months According to Hedge Funds. On September 3, Bradley Canino from Guggenheim initiated coverage on Summit Therapeutics Inc. (NASDAQ:SMMT) with a Buy rating and a $40 price target. The analyst noted that they liked the stock when it was trading at $3 as the market overlooked an important upcoming progression-free survival readout for its drug Ivonescimab in direct comparison to Merck’s Pembrolizumab in lung cancer. No ...

公司调查动态 - Portnoy Law Firm对Summit Therapeutics Inc（纳斯达克代码SMMT）展开涉嫌证券欺诈的调查 可能代表投资者提起集体诉讼[2][4] - 调查涉及公司可能违反联邦证券法行为 重点关注其临床药物数据披露问题[4] 药物临床试验结果 - 2025年5月30日公布ivonescimab联合化疗的三期临床研究HARMONi顶线结果 显示治疗组疾病进展或死亡风险降低48% 但总生存期未达到统计学显著差异[4] - 2025年9月7日追加公布试验数据 显示ivonescimab在北美和欧洲患者中的疗效弱于亚洲患者群体[4] 股价市场反应 - 5月30日负面临床数据导致股价单日下跌7.99美元 跌幅达30.5% 收盘报18.22美元[4] - 9月8日区域疗效差异数据公布后股价再跌6.54美元 单日跌幅25.15% 收盘报19.45美元[4]

Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Sept. 09, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Summit Therapeutics Inc. ("Summit" or the "Company") (NASDAQ: SMMT) investors of a class action representing investors that bought securities between March 17, 2022 and September 22, 2022, inclusive (the "Class Period"). Summit investors have until September 24, 2025 to file a lead plaintiff motion. Investors are encouraged to contact attorney ...

Key Takeaways Summit stock fell 25% after new HARMONi data on its lung cancer drug ivonescimab.Western patients saw a 33% risk reduction, compared with 45% for Asian patients.The FDA has indicated a significant OS benefit is required for drug approval.Shares of Summit Therapeutics (SMMT) tanked 25% yesterday after it reported a final analysis of data from the HARMONi study, which evaluated its investigational antibody ivonescimab in certain patients with non-small cell lung cancer (NSCLC).This analysis show ...

公司活动 - Summit Therapeutics公司举行电话会议更新业务进展 [1] - 首席业务与战略官Dave Gancarz主持本次会议 [1]

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, ...

**Summit Therapeutics (SMMT) 电话会议纪要关键要点** 公司及行业背景 - 公司专注于肺癌治疗药物 ivonescimab（PD-1/VEGF 双特异性抗体）的临床开发[1][2][4] - 核心研究为 Harmony 3 期试验 针对 EGFR 突变非小细胞肺癌（NSCLC）患者 该人群占肺癌市场不足 5%[31][32] - 行业背景：EGFR 突变 NSCLC 靶向治疗后进展的患者治疗选择有限 目前仅有一种美国获批方案（amivantamab + 化疗）[28][29] 核心临床数据（Harmony 试验） **试验设计** - 全球多区域 3 期试验 共纳入 438 例患者 其中北美和欧洲患者占 38%（165 例）[12] - 比较 ivonescimab + 化疗 vs 安慰剂 + 化疗 主要终点为无进展生存期（PFS）和总生存期（OS）[11] **疗效结果** - PFS 显著改善：风险比（HR）= 0.52（p < 0.0001） 中位 PFS 为 6.8 个月 vs 4.4 个月（差异 2.4 个月）[13] - OS 趋势积极：HR = 0.79（p = 0.0570） 中位 OS 为 16.8 个月 vs 14.0 个月[18] - 更新后 OS 分析（2025 年 9 月数据锁库）：HR = 0.78（p = 0.0332） 中位 OS 在西方患者中为 17.0 个月 vs 14.0 个月[20] - 客观缓解率（ORR）绝对改善 11% 中位缓解持续时间（DoR）从 4.2 个月延长至 7.6 个月[23] **亚组分析** - PFS 获益在所有预设亚组中一致 包括脑转移患者（HR = 0.34）和无脑转移患者（HR = 0.59）[15] - 北美患者 OS HR = 0.70 亚洲患者 OS HR = 0.76 显示区域一致性[22][51] **安全性** - 治疗相关不良事件（TRAE）发生率：ivonescimab 组 95% vs 对照组 93% 3 级事件为 50% vs 42%[25] - 免疫相关和 VEGF 相关事件发生率低 3 级出血事件 <1% 停药率 7.3% vs 5%[25][26] 监管与战略规划 - FDA 要求 OS 达到统计学显著性以支持批准[36][37] - 公司计划与 FDA 讨论最新数据（2025 年 9 月锁库）并制定后续策略[37][91] - 计划启动更多 3 期试验（包括非肺癌适应症）并开放合作伙伴关系以加速开发[64][65] 其他关键信息 - 试验设计特殊性：延续中国单区域研究（Harmony A）至多区域 导致西方患者随访时间较短（中位随访 9 个月）[4][6][18] - 西方患者数据成熟度影响初始 OS 结果 更新后分析（中位随访 13.7 个月）显示一致性[19][20] - 竞品对比：ivonescimab 在耐受性和机制上可能优于现有方案（如 amivantamab）[29] - 即将公布数据：Harmony 6（一线鳞状 NSCLC）由合作伙伴 Akeso 主导[66][94] 潜在风险与挑战 - OS 未达到预设统计学显著性阈值（p ≤ 0.0448）[21] - 西方患者招募延迟可能影响数据解读[81][109] - 部分投资者和 KOL 对数据成熟度和区域差异存在质疑[44][70] **数据来源** 所有数据基于 2025 年 9 月 8 日电话会议及 WCLC 2025 公布结果[1][10][20]