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REPL Replimune Group Inc.
盘后交易 08-13 17:46:11 EDT
15.19
-0.05
-0.33%
盘后
15.24
+0.05
+0.33%
17:44 EDT
最高
15.71
最低
14.98
成交量
322.01万
今开
15.00
昨收
15.24
日振幅
4.76%
总市值
14.24亿
流通市值
11.06亿
总股本
9,373万
成交额
4,911万
换手率
4.42%
流通股本
7,281万
市净率
--
ROE
--
每股收益
0.00
52周最高
--
52周最低
--
市盈率
--
股息
--
股息收益率
--
ROA
--
分时
五日
日K
周K
月K
数据加载中...
北京优虎网络科技有限公司
资讯
新帖
简况
Wedbush上调Replimune Group评级至“跑赢大盘”,目标价从12美元升至19美元
美股速递 · 08-07
Wedbush上调Replimune Group评级至“跑赢大盘”,目标价从12美元升至19美元
把肿瘤变成“原位疫苗”!Replimune(REPL.US)溶瘤病毒闯过FDA,PD-1耐药黑色素瘤迎来新一代免疫重启方案
智通财经 · 08-07
把肿瘤变成“原位疫苗”!Replimune(REPL.US)溶瘤病毒闯过FDA,PD-1耐药黑色素瘤迎来新一代免疫重启方案
Replimune宣布:Tudriqevtm联合纳武单抗获FDA加速批准,用于抗PD-1方案后进展的不可切除晚期皮肤黑色素瘤
美股速递 · 08-07
Replimune宣布:Tudriqevtm联合纳武单抗获FDA加速批准,用于抗PD-1方案后进展的不可切除晚期皮肤黑色素瘤
Replimune Group获加速批准:基于客观缓解率与缓解持续时间,确证性研究尚待完成
美股速递 · 08-07
Replimune Group获加速批准:基于客观缓解率与缓解持续时间,确证性研究尚待完成
Leerink Partners上调Replimune Group评级至跑赢大盘,目标股价从11美元升至17美元
美股速递 · 08-04
Leerink Partners上调Replimune Group评级至跑赢大盘,目标股价从11美元升至17美元
Piper Sandler上调Replimune Group Inc.评级至“增持”,目标价从9美元大幅提升至14美元
美股速递 · 07-31
Piper Sandler上调Replimune Group Inc.评级至“增持”,目标价从9美元大幅提升至14美元
美国FDA顾问力挺Replimune皮肤癌药物,盘前股价飙涨逾一倍至11.75美元
美股速递 · 07-31
美国FDA顾问力挺Replimune皮肤癌药物,盘前股价飙涨逾一倍至11.75美元
Replimune公司宣布FDA细胞、组织与基因治疗咨询委员会对Rp1治疗晚期黑色素瘤给出积极评价
美股速递 · 07-31
Replimune公司宣布FDA细胞、组织与基因治疗咨询委员会对Rp1治疗晚期黑色素瘤给出积极评价
美国FDA顾问:Replimune皮肤癌药物研究疗效结果可评估且具临床意义
美股速递 · 07-31
美国FDA顾问:Replimune皮肤癌药物研究疗效结果可评估且具临床意义
FDA内部审查员对Replimune癌症药物试验提出质疑,7月30日咨询委员会会议前发布简报文件
美股速递 · 07-28
FDA内部审查员对Replimune癌症药物试验提出质疑,7月30日咨询委员会会议前发布简报文件
FDA工作人员对疗效提出质疑,Replimune皮肤癌疗法前景堪忧,盘前股价重挫25%
美股速递 · 07-28
FDA工作人员对疗效提出质疑,Replimune皮肤癌疗法前景堪忧,盘前股价重挫25%
Replimune公布2026财年第四季度及全年业绩并更新业务进展
美股速递 · 06-29
Replimune公布2026财年第四季度及全年业绩并更新业务进展
摩根大通将Replimune Group评级上调至“增持”,目标价翻倍至17美元
美股速递 · 06-26
摩根大通将Replimune Group评级上调至“增持”,目标价翻倍至17美元
Replimune宣布FDA受理其Rp1生物制品许可申请重新提交,用于晚期黑色素瘤
美股速递 · 06-26
Replimune宣布FDA受理其Rp1生物制品许可申请重新提交,用于晚期黑色素瘤
Replimune Group:Rp1联合纳武利尤单抗在抗PD-1治疗失败的黑色素瘤患者中实现32.9个月中位总生存期
美股速递 · 05-30
Replimune Group:Rp1联合纳武利尤单抗在抗PD-1治疗失败的黑色素瘤患者中实现32.9个月中位总生存期
美股异动 | 两次遭FDA拒绝后Replimune(REPL.US)皮肤癌药物迎转机 股价暴涨超77%
智通财经 · 05-29
美股异动 | 两次遭FDA拒绝后Replimune(REPL.US)皮肤癌药物迎转机 股价暴涨超77%
Replimune有望与FDA达成协议,将重新提交晚期黑色素瘤疗法以寻求批准
美股速递 · 05-29
Replimune有望与FDA达成协议,将重新提交晚期黑色素瘤疗法以寻求批准
FDA局长Marty Makary为机构对Replimune癌症药物决定辩护后,公司股价下跌5%
美股速递 · 05-05
FDA局长Marty Makary为机构对Replimune癌症药物决定辩护后,公司股价下跌5%
Replimune股价盘前暴跌58% 两款皮肤癌疗法未获FDA批准遭多家券商降级
美股速递 · 04-13
Replimune股价盘前暴跌58% 两款皮肤癌疗法未获FDA批准遭多家券商降级
Replimune:基于FDA反馈启动Ignyte-3试验,满足加速批准所需的确证性研究要求
美股速递 · 04-11
Replimune:基于FDA反馈启动Ignyte-3试验,满足加速批准所需的确证性研究要求
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公司概况
公司名称:
Replimune Group Inc.
所属市场:
NASDAQ
上市日期:
--
主营业务:
Replimune Group, Inc.于2015年在特拉华州注册成立。该公司是一家临床阶段的生物技术公司,致力于应用他们在溶瘤免疫治疗领域的领先专业技术,改变癌症患者的生活。使用该公司专有的Immulytic平台来设计和开发旨在最大限度激活免疫系统对抗癌症的候选产品。
发行价格:
--
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04:01","pubTimestamp":1786046474,"startTime":"0","endTime":"0","summary":"Replimune Group Inc.宣布,其创新疗法Tudriqevtm与纳武单抗联合用药,已获得美国食品药品监督管理局(FDA)的加速批准。这一批准针对的是那些在接受抗PD-1为基础的治疗方案后,疾病仍出现进展的不可切除晚期皮肤黑色素瘤患者。此举标志着在肿瘤免疫治疗领域,又一重要里程碑的达成。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1187007639","title":"Replimune Group获加速批准:基于客观缓解率与缓解持续时间,确证性研究尚待完成","url":"https://stock-news.laohu8.com/highlight/detail?id=1187007639","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1187007639?lang=zh_cn&edition=full","pubTime":"2026-08-07 04:01","pubTimestamp":1786046472,"startTime":"0","endTime":"0","summary":"Replimune Group Inc. 的批准依据,聚焦于客观缓解率与缓解持续时间这两个关键指标。然而,这并非终点——确证性试验的要求,如同悬在头顶的利剑,仍需后续完成。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1171415359","title":"Leerink Partners上调Replimune Group评级至跑赢大盘,目标股价从11美元升至17美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1171415359","media":"美股速递","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1171415359?lang=zh_cn&edition=full","pubTime":"2026-08-04 11:04","pubTimestamp":1785812659,"startTime":"0","endTime":"0","summary":"Leerink Partners近日调整了对Replimune Group Inc.(REPL)的评级,将其从“市场表现”上调至“跑赢大盘”。与此同时,这家投行还将该股的目标股价从此前的11.00美元大幅提升至17.00美元。这一调整反映了机构对其前景的乐观态度。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"shareholding","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1159719965","title":"Piper Sandler上调Replimune Group Inc.评级至“增持”,目标价从9美元大幅提升至14美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1159719965","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1159719965?lang=zh_cn&edition=full","pubTime":"2026-07-31 20:48","pubTimestamp":1785502125,"startTime":"0","endTime":"0","summary":"Piper Sandler对Replimune Group Inc.(股票代码:REPL)的评级进行了显著调整。这家投行将该公司股票评级从“中性”一举上调至“增持”,与此同时,其目标价也从之前的9美元大幅提高至14美元。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1105497517","title":"美国FDA顾问力挺Replimune皮肤癌药物,盘前股价飙涨逾一倍至11.75美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1105497517","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1105497517?lang=zh_cn&edition=full","pubTime":"2026-07-31 17:46","pubTimestamp":1785491170,"startTime":"0","endTime":"0","summary":"Replimune Group Inc.的股价在盘前交易中飙升。该公司股价涨幅超过一倍,达到了11.75美元。这一惊人涨势的背后,是来自美国食品药品监督管理局(FDA)顾问委员会的支持。这些专家们一致认可了Replimune所研发的皮肤癌药物。市场对这一积极信号反应极为热烈,直接推动股价大幅攀升。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1149658600","title":"Replimune公司宣布FDA细胞、组织与基因治疗咨询委员会对Rp1治疗晚期黑色素瘤给出积极评价","url":"https://stock-news.laohu8.com/highlight/detail?id=1149658600","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1149658600?lang=zh_cn&edition=full","pubTime":"2026-07-31 06:17","pubTimestamp":1785449845,"startTime":"0","endTime":"0","summary":"Replimune Group Inc.正式宣布,美国食品药品监督管理局(FDA)下属的细胞、组织与基因治疗咨询委员会,已就其在研疗法Rp1用于治疗晚期黑色素瘤一事,给出了有利的审议结果。这一进展标志着该公司在肿瘤免疫治疗领域的研发迈出了关键一步。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1194793413","title":"美国FDA顾问:Replimune皮肤癌药物研究疗效结果可评估且具临床意义","url":"https://stock-news.laohu8.com/highlight/detail?id=1194793413","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1194793413?lang=zh_cn&edition=full","pubTime":"2026-07-31 04:49","pubTimestamp":1785444549,"startTime":"0","endTime":"0","summary":"美国FDA顾问指出,Replimune Group Inc.旗下皮肤癌药物研究的疗效数据不仅具备可评估性,而且具有显著的临床意义。这些结论标志着该药物在研发进程中迈出了关键一步。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1121106550","title":"FDA内部审查员对Replimune癌症药物试验提出质疑,7月30日咨询委员会会议前发布简报文件","url":"https://stock-news.laohu8.com/highlight/detail?id=1121106550","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1121106550?lang=zh_cn&edition=full","pubTime":"2026-07-28 19:42","pubTimestamp":1785238937,"startTime":"0","endTime":"0","summary":"在即将于7月30日召开的咨询委员会会议前夕,美国食品药品监督管理局的内部审查人员对Replimune Group Inc.的癌症药物试验提出了若干关键性担忧。这些担忧已通过一份详细简报文件正式披露。Replimune正致力于开发一种新型的溶瘤病毒免疫疗法,旨在激活患者自身免疫系统以对抗肿瘤。此次审查意见的发布,标志着FDA在正式决策前与外部专家进行深入探讨的重要环节。最终结果不仅可能影响Replimune的研发进程,亦可能为同类癌症免疫治疗方案带来监管风向标。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1186148876","title":"FDA工作人员对疗效提出质疑,Replimune皮肤癌疗法前景堪忧,盘前股价重挫25%","url":"https://stock-news.laohu8.com/highlight/detail?id=1186148876","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1186148876?lang=zh_cn&edition=full","pubTime":"2026-07-28 19:41","pubTimestamp":1785238870,"startTime":"0","endTime":"0","summary":"FDA工作人员对Replimune Group Inc.旗下皮肤癌治疗方案的疗效提出质疑,引发市场剧烈反应——该公司盘前股价应声暴跌25%,跌幅令人咋舌。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1198316202","title":"Replimune公布2026财年第四季度及全年业绩并更新业务进展","url":"https://stock-news.laohu8.com/highlight/detail?id=1198316202","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1198316202?lang=zh_cn&edition=full","pubTime":"2026-06-29 20:00","pubTimestamp":1782734429,"startTime":"0","endTime":"0","summary":"Replimune Group Inc. 已发布其2026财年第四季度及全年财务报告,同时向市场通报了公司最新的运营动态。此次披露涵盖了关键财务数据与战略发展近况,为投资者提供了评估公司业绩与未来前景的重要依据。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1170634578","title":"摩根大通将Replimune Group评级上调至“增持”,目标价翻倍至17美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1170634578","media":"美股速递","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1170634578?lang=zh_cn&edition=full","pubTime":"2026-06-26 23:30","pubTimestamp":1782487819,"startTime":"0","endTime":"0","summary":"摩根大通发布最新研究报告,将生物技术公司Replimune Group Inc.的股票评级从“中性”大幅上调至“增持”。与此同时,该行将其目标价从原先的8美元显著提升至17美元,涨幅超过一倍。\n此举反映了摩根大通对该公司未来发展前景的积极看法转变。目标价的大幅上调,通常意味着分析师认为公司基本面或市场环境出现了显著改善,其股价有较大的上行潜力。评级调整与目标价变动,是投资者评估股票价值与风险时关注的重要参考指标。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"shareholding","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1199980725","title":"Replimune宣布FDA受理其Rp1生物制品许可申请重新提交,用于晚期黑色素瘤","url":"https://stock-news.laohu8.com/highlight/detail?id=1199980725","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1199980725?lang=zh_cn&edition=full","pubTime":"2026-06-26 20:00","pubTimestamp":1782475247,"startTime":"0","endTime":"0","summary":"Replimune Group Inc. 宣布,美国食品药品监督管理局(FDA)已正式受理其针对候选疗法RP1用于治疗晚期黑色素瘤的生物制品许可申请(BLA)的重新提交。\n此次受理标志着该公司在推进这一溶瘤病毒免疫疗法上市进程中迈出了关键一步。FDA设定的处方药用户费用法案(PDUFA)目标审评日期为2024年12月25日。\n该BLA的提交主要基于关键的CERPASS临床试验数据,该研究评估了RP1与抗PD-1疗法利博利单抗联合使用,相较于单独使用利博利单抗,在晚期黑色素瘤患者中的疗效与安全性。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1189204083","title":"Replimune Group:Rp1联合纳武利尤单抗在抗PD-1治疗失败的黑色素瘤患者中实现32.9个月中位总生存期","url":"https://stock-news.laohu8.com/highlight/detail?id=1189204083","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1189204083?lang=zh_cn&edition=full","pubTime":"2026-05-30 20:11","pubTimestamp":1780143081,"startTime":"0","endTime":"0","summary":"Replimune Group Inc.公布其候选疗法Rp1联合纳武利尤单抗的最新数据,在对抗PD-1疗法已产生耐药性的晚期黑色素瘤患者群体中,展现出令人瞩目的长期生存获益,中位总生存期达到32.9个月。这一结果凸显了该联合疗法为这类难治性患者提供潜在新治疗选择的临床价值。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2639067536","title":"美股异动 | 两次遭FDA拒绝后Replimune(REPL.US)皮肤癌药物迎转机 股价暴涨超77%","url":"https://stock-news.laohu8.com/highlight/detail?id=2639067536","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2639067536?lang=zh_cn&edition=full","pubTime":"2026-05-29 22:30","pubTimestamp":1780065021,"startTime":"0","endTime":"0","summary":"智通财经APP获悉,周五,Replimune股价暴涨,截至发稿,该股涨超77%,报8.27美元。今年4月,FDA第二次否决了Replimune针对晚期黑色素瘤的联合疗法,该方案结合了公司自研的免疫疗法与另一种抗癌药物。FDA此次转变态度,决定重新考虑Replimune的申请,外界普遍解读为,该机构在药物审评方面的强硬立场可能正在松动。截至周四收盘,Replimune股价今年已累计下跌52%。近期FDA连续拒绝多款药物申请,已引发业界普遍担忧。","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://www.zhitongcaijing.com/content/detail/1448093.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["REPL","BK4585","LABU","BK4588","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1143933611","title":"Replimune有望与FDA达成协议,将重新提交晚期黑色素瘤疗法以寻求批准","url":"https://stock-news.laohu8.com/highlight/detail?id=1143933611","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1143933611?lang=zh_cn&edition=full","pubTime":"2026-05-29 19:34","pubTimestamp":1780054456,"startTime":"0","endTime":"0","summary":"生物技术公司Replimune Group Inc.预计将宣布与美国食品药品监督管理局(FDA)达成一项协议,为其晚期黑色素瘤治疗药物重新提交上市申请。\n根据报道,双方已就相关事宜进行了沟通,并有望在近期正式公布这一安排。此举旨在解决此前申请过程中可能存在的问题,并为该疗法的最终获批铺平道路。\nReplimune的这款疗法针对晚期黑色素瘤患者,属于其研发管线中的重要候选药物。与监管机构达成协议,通常意味着公司获得了明确的路径指引,以补充数据或调整方案,从而再次寻求监管批准。这一进展对于依赖该产品未来商业前景的Replimune而言,是一个积极的信号。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1147501425","title":"FDA局长Marty Makary为机构对Replimune癌症药物决定辩护后,公司股价下跌5%","url":"https://stock-news.laohu8.com/highlight/detail?id=1147501425","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1147501425?lang=zh_cn&edition=full","pubTime":"2026-05-05 22:52","pubTimestamp":1777992722,"startTime":"0","endTime":"0","summary":"在FDA局长Marty Makary公开为监管机构对Replimune Group Inc.癌症药物的审评决定进行辩护后,该公司股价应声下跌5%。\n这一市场反应凸显了投资者对监管态度的敏感程度。Makary局长的表态被视为对Replimune药物前景的重要信号,直接影响了市场情绪。\n生物科技板块往往对监管动态表现出高度敏感性。此次股价波动再次印证了这一行业特性,同时也反映出市场对Replimune特定药物研发进展的持续关注。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","REPL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1188277711","title":"Replimune股价盘前暴跌58% 两款皮肤癌疗法未获FDA批准遭多家券商降级","url":"https://stock-news.laohu8.com/highlight/detail?id=1188277711","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1188277711?lang=zh_cn&edition=full","pubTime":"2026-04-13 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(REPL) 股价在盘前交易中重挫58%,创下历史最大单日跌幅。此次暴跌源于该公司针对晚期皮肤癌的两款核心疗法未能获得美国食品药品监督管理局(FDA)的批准许可。\n至少两家知名券商随后发布紧急报告,同步下调该股投资评级。分析师指出,监管审批的挫败不仅直接影响公司短期现金流,更对其肿瘤免疫疗法的商业化前景造成实质性打击。\n市场人士认为,此次FDA的否决决定可能迫使Replimune重新调整临床开发策略。受此影响,多只生物科技ETF持仓组合中出现连锁反应,板块情绪显著受挫。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["REPL","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1106873747","title":"Replimune:基于FDA反馈启动Ignyte-3试验,满足加速批准所需的确证性研究要求","url":"https://stock-news.laohu8.com/highlight/detail?id=1106873747","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1106873747?lang=zh_cn&edition=full","pubTime":"2026-04-11 05:06","pubTimestamp":1775855171,"startTime":"0","endTime":"0","summary":"生物技术公司Replimune Group Inc. 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