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Celcuity Inc

63.19

-2.6600-4.04%

盘后：63.190.00000.00%16:54 EDT

成交量：145.93万

成交额：9,297.68万

市值：30.82亿

市盈率：-14.62

高：65.69

开：65.17

低：62.86

收：65.85

52周最高：151.02

52周最低：45.03

股本：4,876.63万

流通股本：2,971.92万

量比：0.76

换手率：4.91%

股息：- -

股息率：- -

每股收益(TTM):-4.3223

每股收益(LYR):-3.7900

净资产收益率：-1433.70%

总资产收益率：-25.78%

市净率：-241.10

市盈率(LYR):-16.67

数据加载中...

总览公司新闻资讯公告

异动解读｜Celcuity盘中上涨5.22%，FDA关键审评日临近催化市场预期

异动解读｜Celcuity盘中下跌5.37%，FDA审评目标日期临近多空博弈加剧

异动解读｜Celcuity盘中上涨5.02%，核心药物FDA审评目标日期临近

市场快讯——美股行情动态-联合健康集团、Pinterest、Celcuity

Celcuity Inc. 定价增发5亿美元、2032年到期的0.25%可转换优先票据

市场快讯——美股行情动态-美国稀土、MiniMed、Rent the Runway

热门话题-Celcuity宣布发行4亿美元可转换债券后股价进一步下跌

Celcuity Inc宣布公开发行2032年到期的可转换优先票据

Celcuity股价暴跌，因乳腺癌实验性治疗数据令人失望

异动解读｜Celcuity盘中下跌23.24%，III期VIKTORIA-1临床数据公布后股价承压

Celcuity公布III期VIKTORIA-1试验PIK3CA突变队列结果 - SEC文件披露

FDA授予Celcuity公司Gedatolisib新药申请优先审评资格；PDUFA目标日期定于2026年7月17日

Celcuity：Gedatolisib三联疗法对比Alpelisib联合Fulvestrant，中位无进展生存期达11.1个月 vs 5.6个月

Celcuity公司：Gedatolisib治疗方案总体耐受性良好，不良事件多为低级别

Celcuity公司将于2026年6月2日召开电话会议，讨论Gedatolisib方案针对HR+/HER-晚期乳腺癌的3期Viktoria-1临床试验中PIK3CA突变队列的结果

Celcuity Inc：预计现金、现金等价物、投资及信贷额度提款将支撑运营至2027年

异动解读 | 新药获FDA优先审评且临床试验扩大，Celcuity盘中大涨6.23%

Celcuity Inc 新药申请获FDA优先审评资格，关键审评日期定于2026年7月17日

Celcuity公司Gedatolisib一线治疗HR+/HER2-晚期乳腺癌的III期Viktoria-2试验将扩大至纳入内分泌敏感患者

Celcuity公司Viktoria-1三期试验达成主要终点 Pik3CA突变队列无进展生存期获临床意义改善

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00:07","pubTimestamp":1783440465,"startTime":"0","endTime":"0","summary":"7月8日，Celcuity盘中上涨5.02%，报114.03美元/股，成交额5562.87万美元。消息面上，公司核心候选药物gedatolisib的FDA处方药用户付费法案目标审评日期定于7月17日，距今仅约一周。该药物此前已获FDA新药申请优先审评资格，用于HR+/HER2-/PIK3CA突变晚期乳腺癌治疗。III期Viktoria-1试验数据显示，gedatolisib三联疗法将疾病进展或死亡风险降低50%，中位无进展生存期达11.1个月，较对照组5.6个月近乎翻倍。市场对即将到来的FDA审批决定持乐观预期，推动股价走强。","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":["CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640166952","title":"市场快讯——美股行情动态-联合健康集团、Pinterest、Celcuity","url":"https://stock-news.laohu8.com/highlight/detail?id=2640166952","media":"路透中文","labels":["event"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640166952?lang=zh_cn&edition=fundamental","pubTime":"2026-06-04 23:47","pubTimestamp":1780588076,"startTime":"0","endTime":"0","summary":"美国东部时间11:30，道琼斯工业平均指数 .DJI 上涨1.75%，报51,575.56点。标普500指数 .SPX 上涨0.27%，报7,573.97点；纳斯达克综合指数 .IXIC 下跌0.19%，报26,801.49点。","market":"us","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":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260604:nL4S42C1FS:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"event","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0203347892.USD","LU0432979614.USD","SG9999014914.USD","SG9999014906.USD","IE00B2B36J28.USD","LU0077335932.USD","BK4139","IE00BJJMRZ35.SGD","LU0256863811.USD","IE00B19Z3581.USD","LU1551013342.USD","LU2089283258.USD","IE0004445239.USD","BK4588","LU1061106388.HKD","LU0211327993.USD","LU2125154778.USD","LU0128525689.USD","LU2361044949.HKD","BK4585","LU2362541513.USD","SG9999018865.SGD","LU2279689827.SGD","LU0795875169.SGD","LU1720051017.SGD","BK4581","LU0689472784.USD","LU1496350502.SGD","LU0456855351.SGD","LU0094547139.USD","LU1069347547.HKD","LU2028103732.USD","LU1066051225.USD","LU0545039389.USD","IE00B19Z9P08.USD","LU1989771016.USD","LU2089984988.USD","LU0234572021.USD","LU0203345920.USD","IE00B894F039.SGD","LU0289739699.SGD","LU0496365809.HKD","LU1066053197.SGD","LU2362540622.SGD","IE00B19Z8W00.USD","LU2468319806.SGD","LU2491050154.USD","LU2552382215.SGD","BK4533","IE00BKPKM429.USD","LU0011850046.USD","LU0342679015.USD","LU0965509010.AUD","LU0348723411.USD","PINS","IE00B19Z9505.USD","IE00BJJMRY28.SGD","IE00BJT1NW94.SGD","SG9999001176.USD","LU1778281490.HKD","LU2357305700.SGD","LU1732800096.USD","SG9999002224.SGD","LU0820562030.AUD","IE00BJJMRX11.SGD","LU2242649171.HKD","GB00BDT5M118.USD","IE00B1XK9C88.USD","LU0158827948.USD","LU1084165304.USD","LU1674673691.USD","LU2112291526.USD","LU0128525929.USD","LU1506573853.SGD","LU0861579265.USD","LU0708995401.HKD","IE000M9KFDE8.USD","LU1670627923.USD","LU0345770993.USD","LU0965508806.USD","LU1323610961.USD","LU0553294199.USD","SGXZ99366536.SGD","LU0661504455.SGD","LU0114720955.EUR","LU0310800965.SGD","IE00B4JS1V06.HKD","LU0528227936.USD","LU0820561909.HKD","LU0795875086.SGD","LU1153585028.USD","BK4548","LU2361044865.SGD","LU2023251221.USD","IE0009355771.USD","LU2361045086.USD","SGXZ51526630.SGD","LU1267930573.SGD","LU0949170772.SGD","LU2317271919.USD","CELC","LU0052756011.USD","LU1267930730.SGD","LU0557290698.USD","LU1064131342.USD","LU1119994496.HKD","LU1023059063.AUD","LU1551013425.SGD","LU2125154935.USD","IE0005OL40V9.USD","UNHG","LU0079474960.USD","LU2271345857.HKD","LU1003077747.HKD","LU0345770308.USD","LU2111349929.HKD","BK4566","IE00BFTCPJ56.SGD","LU2324357040.USD","LU0353189680.USD","LU2244417387.USD","LU1267930490.SGD","SG9999018857.SGD","LU2347655156.SGD","BK4154","BK4534","LU0158827781.USD","IE00B19Z3B42.SGD","IE00BFXG1179.USD","LU2087625088.SGD","SG9999014898.SGD","BK4508","IE00BZ9MQY76.HKD","SGXZ81514606.USD","LU2133065610.SGD","LU0122379950.USD","LU0198837287.USD","IE00BFSS7M15.SGD","IE00B1BXHZ80.USD","LU0353189763.USD","LU0708994859.HKD","LU1791710582.SGD","LU1988902786.USD","LU1035773651.USD","LU0187121727.USD","LU0943347566.SGD","LU1732799900.SGD","LU0965509101.SGD","LU0820561818.USD","LU0266013472.USD","IE00BKVL7J92.USD","LU2236285917.USD","LU0683600562.USD","SG9999001176.SGD","LU0058720904.USD","IE00BFSS8Q28.SGD","IE0004445015.USD","LU0738911758.USD","LU2362541273.HKD","LU0882574055.USD","BK4551","LU1814569148.SGD","LU0672654240.SGD","LU0976567544.SGD","LU0238689110.USD","SG9999014880.SGD","SG9999002232.USD","IE00BN29S564.USD","LU0417517546.SGD","IE00BWXC8680.SGD","LU0912757837.SGD","SG9999013999.USD","LU1037948541.HKD","LU0354030511.USD","LU1066051498.USD","LU2552382132.HKD","LU1914381329.SGD","LU2264538146.SGD","LU0965509283.SGD","LU0211328371.USD","IE00B7KXQ091.USD","LU0320765059.SGD","LU1548497426.USD","LU0310799852.SGD","LU0048584097.USD","LU0787776722.HKD","LU0109391861.USD","LU1934455194.USD","LU1854104046.USD","LU2461242641.AUD","IE00B775H168.HKD","SG9999017495.SGD","IE00B19Z8X17.USD","LU0211326839.USD","LU1261432733.SGD","LU2211815571.USD","IE0002141913.USD","IE0002270589.USD","LU2491049909.HKD","LU2491050071.SGD","IE00B7SZLL34.SGD","SGXZ31699556.SGD","LU1037948897.HKD","LU1720051108.HKD","LU0107464264.USD","LU1670628061.USD","LU1934455277.USD","SGXZ57979304.SGD","IE00BSNM7G36.USD","LU0354030438.USD","LU1854103824.USD","LU1718418525.SGD","LU1983299246.USD","LU0310800379.SGD","LU0823416689.USD","IE00B3T34201.USD","IE00BZ1G4Q59.USD","LU0251132253.USD","LU1674673428.USD","LU1267930227.SGD","LU2360032135.SGD","LU2552382058.USD","LU2089284900.SGD","LU0029864427.USD","LU0211326755.USD","LU1066051811.HKD","LU1791710400.SGD","UNHW","LU1057294990.SGD","LU0316494557.USD","BK4077","IE00B4R5TH58.HKD","BK4532","LU0097036916.USD","UNH","LU1074936037.SGD","LU1934455863.HKD","LU0053666078.USD","LU1291159041.SGD","LU0149725797.USD","IE00B19Z9Z06.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1187497120","title":"Celcuity Inc. 定价增发5亿美元、2032年到期的0.25%可转换优先票据","url":"https://stock-news.laohu8.com/highlight/detail?id=1187497120","media":"投资观察","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1187497120?lang=zh_cn&edition=fundamental","pubTime":"2026-06-04 10:23","pubTimestamp":1780539808,"startTime":"0","endTime":"0","summary":"6月3日 - 生物技术公司 Celcuity Inc. 宣布，已为其增发的2032年到期、利率为0.250%的可转换优先票据完成定价。此次发行规模最终确定为5亿美元。\n该笔票据的发行规模较原计划有所扩大，凸显了市场对其融资条款的认可。可转换票据为投资者提供了未来将债务转换为公司股权的选择权，是成长型公司常见的融资工具之一。","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":["CELC","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640835721","title":"市场快讯——美股行情动态-美国稀土、MiniMed、Rent the Runway","url":"https://stock-news.laohu8.com/highlight/detail?id=2640835721","media":"路透中文","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640835721?lang=zh_cn&edition=fundamental","pubTime":"2026-06-03 23:44","pubTimestamp":1780501468,"startTime":"0","endTime":"0","summary":".N美国东部时间11:30，道琼斯工业平均指数 .DJI 下跌0.73%，报50,932.08点。标普500指数 .SPX 下跌0.45%，报7,575.85点；纳斯达克综合指数 .IXIC 下跌0.65%，报26,917.86点。","market":"hk","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":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260603:nL4T42B1G0:1","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":["GME","CTMX","XOS","KKR","STLD","COCP","GMEY","FLR","FDX","TPL","USAR","RENT","OWL","SDOT","MLYS","OLLI","NRXP","TISI","AXSM","REGN","GPN","THO","MX","JZ","BX","HGV","INCY","TTI","CETX","ARES","RJF","SMR","MDT","HIMS","LDOS","GTLB","LUNR","MMED","TBN","YUM","TGTX","FICO","GRRR","NOTV","WCT","WDC","AADX","TE","CELC"],"isVideo":false,"video":null,"gpt_icon":1},{"id":"2640900712","title":"热门话题-Celcuity宣布发行4亿美元可转换债券后股价进一步下跌","url":"https://stock-news.laohu8.com/highlight/detail?id=2640900712","media":"路透中文","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640900712?lang=zh_cn&edition=fundamental","pubTime":"2026-06-03 22:34","pubTimestamp":1780497259,"startTime":"0","endTime":"0","summary":"由于自动化翻译可能有误，或未能包含所需语境，路透不保证自动化翻译文本的准确性，仅是为了便利读者而提供自动化翻译。对于因为使用自动化翻译功能而造成的任何损害或损失，路透不承担任何责任。","market":"us","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":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260603:nL4T42B1D9:1","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","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1187515046","title":"Celcuity Inc宣布公开发行2032年到期的可转换优先票据","url":"https://stock-news.laohu8.com/highlight/detail?id=1187515046","media":"投资观察","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1187515046?lang=zh_cn&edition=fundamental","pubTime":"2026-06-03 19:39","pubTimestamp":1780486794,"startTime":"0","endTime":"0","summary":"Celcuity Inc于6月3日宣布，将公开发行一批于2032年到期的可转换优先票据。此举旨在为公司运营及战略发展募集资金。","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":"shareholding","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640947864","title":"Celcuity股价暴跌，因乳腺癌实验性治疗数据令人失望","url":"https://stock-news.laohu8.com/highlight/detail?id=2640947864","media":"路透中文","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2640947864?lang=zh_cn&edition=fundamental","pubTime":"2026-06-03 01:17","pubTimestamp":1780420658,"startTime":"0","endTime":"0","summary":"路透6月2日 - Celcuity股价周二暴跌25% CELC.O，创下该公司最大单日跌幅，此前其一款实验性乳腺癌治疗药物虽延长了患者无病进展生存期，但疗效表现逊于此前一项试验。在一项涉及30名患者的小型早期试验中，Celcuity的药物组合显示出14.6个月的PFS。Celcuity计划为gedatolisib提交补充上市申请，以扩大适应症范围，使其适用于所有晚期乳腺癌患者，无论其PIK3CA基因状态如何。","market":"hk","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":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260602:nL4T42A1J3:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1199488490","title":"异动解读｜Celcuity盘中下跌23.24%，III期VIKTORIA-1临床数据公布后股价承压","url":"https://stock-news.laohu8.com/highlight/detail?id=1199488490","media":"行情直击","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1199488490?lang=zh_cn&edition=fundamental","pubTime":"2026-06-03 00:20","pubTimestamp":1780417249,"startTime":"0","endTime":"0","summary":"6月2日，Celcuity盘中下跌23.24%，报93.69美元/股，成交额3.2亿美元。消息面上，公司通过SEC文件公布了III期VIKTORIA-1试验PIK3CA突变队列结果：Gedatolisib三联疗法中位无进展生存期为11.1个月，对照组Alpelisib联合Fulvestrant为5.6个月；安全性方面不良事件多为低级别。FDA已授予其新药申请优先审评资格，PDUFA目标日期定为7月17日。尽管临床数据及监管进展积极，股价仍大幅回落，提示市场此前或已充分定价甚至对数据抱有更高预期。","market":"hk","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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1169917585","title":"Celcuity公布III期VIKTORIA-1试验PIK3CA突变队列结果 - SEC文件披露","url":"https://stock-news.laohu8.com/highlight/detail?id=1169917585","media":"投资观察","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1169917585?lang=zh_cn&edition=fundamental","pubTime":"2026-06-02 20:34","pubTimestamp":1780403640,"startTime":"0","endTime":"0","summary":"Celcuity公司近期通过提交给美国证券交易委员会的文件，公布了其关键III期VIKTORIA-1临床试验中针对PIK3CA突变患者队列的详细数据。安全性方面，gedatolisib相关治疗方案普遍耐受性良好，报告的大多数不良事件为低级别。美国食品药品监督管理局已授予Celcuity公司gedatolisib的新药申请优先审评资格，并设定了处方药用户付费法案目标日期为2026年7月17日。公司表示，若获得FDA批准，正按计划推进gedatolisib在2026年第三季度的商业化上市准备工作。","market":"hk","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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1107864078","title":"FDA授予Celcuity公司Gedatolisib新药申请优先审评资格；PDUFA目标日期定于2026年7月17日","url":"https://stock-news.laohu8.com/highlight/detail?id=1107864078","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1107864078?lang=zh_cn&edition=fundamental","pubTime":"2026-06-02 20:16","pubTimestamp":1780402573,"startTime":"0","endTime":"0","summary":"美国食品药品监督管理局（FDA）已授予Celcuity公司旗下药物Gedatolisib的新药申请（NDA）优先审评资格。根据提交至美国证券交易委员会（SEC）的文件，该申请的处方药使用者付费法案（PDUFA）目标日期设定为2026年7月17日。此举标志着该药物在监管审批流程中迈出了关键一步，有望加速其上市进程。","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":["BK4139","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1134324033","title":"Celcuity：Gedatolisib三联疗法对比Alpelisib联合Fulvestrant，中位无进展生存期达11.1个月 vs 5.6个月","url":"https://stock-news.laohu8.com/highlight/detail?id=1134324033","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1134324033?lang=zh_cn&edition=fundamental","pubTime":"2026-06-02 20:15","pubTimestamp":1780402521,"startTime":"0","endTime":"0","summary":"根据一份提交给美国证券交易委员会的文件，Celcuity Inc 公布的数据显示，其Gedatolisib三联疗法在关键试验中取得了显著成果。\n该疗法展现出的中位无进展生存期达到11.1个月，而对照组使用Alpelisib联合Fulvestrant方案的中位无进展生存期仅为5.6个月。这一对比数据突显了Gedatolisib三联疗法的潜在优势。","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","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1179894923","title":"Celcuity公司：Gedatolisib治疗方案总体耐受性良好，不良事件多为低级别","url":"https://stock-news.laohu8.com/highlight/detail?id=1179894923","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1179894923?lang=zh_cn&edition=fundamental","pubTime":"2026-06-02 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在其临床研究中评估的Gedatolisib治疗方案展现出积极的耐受性特征。数据显示，该治疗方案总体上被患者良好耐受，所报告的大多数不良事件严重程度较低，属于低级别范畴。这一发现为后续的临床开发提供了支持性数据。","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":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CELC","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1113606237","title":"Celcuity公司将于2026年6月2日召开电话会议，讨论Gedatolisib方案针对HR+/HER-晚期乳腺癌的3期Viktoria-1临床试验中PIK3CA突变队列的结果","url":"https://stock-news.laohu8.com/highlight/detail?id=1113606237","media":"美股速递","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1113606237?lang=zh_cn&edition=fundamental","pubTime":"2026-06-01 20:30","pubTimestamp":1780317020,"startTime":"0","endTime":"0","summary":"Celcuity公司计划于2026年6月2日举行一场电话会议，专门探讨其关键候选药物Gedatolisib联合方案在HR+/HER-晚期乳腺癌患者中的最新临床数据。此次会议的核心议题，将聚焦于3期Viktoria-1临床试验中，针对携带PIK3CA基因突变的患者队列所获得的详细结果。该数据的公布，预计将为评估Gedatolisib在这一特定患者群体中的疗效与安全性提供关键洞见，并可能影响未来的治疗策略与监管路径。","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":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1122239009","title":"Celcuity Inc：预计现金、现金等价物、投资及信贷额度提款将支撑运营至2027年","url":"https://stock-news.laohu8.com/highlight/detail?id=1122239009","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1122239009?lang=zh_cn&edition=fundamental","pubTime":"2026-05-15 04:04","pubTimestamp":1778789052,"startTime":"0","endTime":"0","summary":"Celcuity Inc 预计，其现有的现金及现金等价物、投资组合，以及通过信贷额度进行的潜在提款，将共同为公司运营提供资金支持，直至2027年。","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":["CELC","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1147706263","title":"异动解读 | 新药获FDA优先审评且临床试验扩大，Celcuity盘中大涨6.23%","url":"https://stock-news.laohu8.com/highlight/detail?id=1147706263","media":"异动解读","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1147706263?lang=zh_cn&edition=fundamental","pubTime":"2026-05-14 22:13","pubTimestamp":1778768010,"startTime":"0","endTime":"0","summary":"Celcuity Inc今日盘中股价大涨6.23%，引起了市场的广泛关注。首先，Celcuity Inc宣布，其针对核心药物Gedatolisib的新药申请已获得美国食品药品监督管理局的优先审评资格，关键审评日期定于2026年7月17日，这标志着该药物在监管审批流程中迈出了关键一步，有望加速上市进程。与此同时，公司另一则公告显示，其针对Gedatolisib作为HR+/HER2-晚期乳腺癌一线疗法的III期Viktoria-2临床试验，将扩大招募范围，将内分泌敏感患者群体也纳入其中。","market":"hk","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":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_cn","symbols":["CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1142039438","title":"Celcuity Inc 新药申请获FDA优先审评资格，关键审评日期定于2026年7月17日","url":"https://stock-news.laohu8.com/highlight/detail?id=1142039438","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1142039438?lang=zh_cn&edition=fundamental","pubTime":"2026-05-14 19:31","pubTimestamp":1778758282,"startTime":"0","endTime":"0","summary":"Celcuity Inc 宣布，其针对Gedatolisib的新药申请已获得美国食品药品监督管理局的优先审评资格。该申请的处方药用户付费法案目标审评日期定为2026年7月17日。此项决定标志着该药物在监管审批流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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CELC"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1155265476","title":"Celcuity公司Gedatolisib一线治疗HR+/HER2-晚期乳腺癌的III期Viktoria-2试验将扩大至纳入内分泌敏感患者","url":"https://stock-news.laohu8.com/highlight/detail?id=1155265476","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1155265476?lang=zh_cn&edition=fundamental","pubTime":"2026-05-14 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