美股詳情

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萬達生物製藥

8.60

-0.2100-2.38%

盤後：8.760.1640+1.91%18:29 EDT

成交量：121.02萬

成交額：1,037.29萬

市值：5.08億

市盈率：-2.30

高：8.88

開：8.73

低：8.41

收：8.81

52周最高：9.94

52周最低：3.81

股本：5,909.66萬

流通股本：4,948.31萬

量比：0.59

換手率：2.45%

股息：- -

股息率：- -

每股收益(TTM):-3.7413

每股收益(LYR):-3.7413

淨資產收益率：-50.93%

總資產收益率：-16.50%

市淨率：1.55

市盈率(LYR):-2.30

資料載入中...

總覽公司新聞資訊公告

歐洲藥管局拒絕Hetlioz新增史密斯-馬吉利斯綜合徵成人夜間睡眠障礙適應症的申請

Vanda Pharmaceuticals Inc.盤中異動大幅上漲5.07%報8.29美元

BUZZ-美國食品及藥物管理局罕見地就時差藥競標舉行聽證會後，萬達股價上漲

萬達生物製藥宣佈美國FDA為Hetlioz®時差障礙適應症召開里程碑式聽證會，系40餘年來首次新藥審批聽證

EMA人用醫藥產品委員會：萬達生物製藥的伊洛哌酮獲負面意見用於精神分裂症治療

萬達生物製藥盤前股價上漲2.3%，FDA受理其罕見皮膚病藥物審查申請

BUZZ-FDA接受罕見皮膚病藥物審查申請，萬達股價上漲

萬達生物製藥宣佈美國FDA受理imsidolimab治療泛發性膿皰型銀屑病的生物製品許可申請

萬達生物製藥宣佈美國FDA受理Imsidolimab治療泛發性膿皰型銀屑病的生物製品許可申請

BUZZ--美國股票走勢-禮來、達美樂、諾和諾德

BUZZ-美國 FDA 批准新型抗精神病藥，萬達醫藥一躍而起

BUZZ-抗精神病藥物獲 FDA 批准後，萬達業績大漲

萬達生物製藥更新Bysanti安全警告：老年痴呆相關精神病患者死亡率上升

美國食品和藥物管理局批准萬達的精神科藥物

萬達生物製藥宣佈Bysanti™（米沙哌隆）獲FDA批准用於治療雙相I型障礙和精神分裂症——新化學實體開啓精神科創新新紀元

萬達生物製藥公布年度營收指引：現有商業化產品收入預計達2.3億至2.6億美元

BUZZ--美國股票走勢-布魯姆能源公司、泰森食品公司、旅行者科技公司

美國FDA拒絕時差症藥物申請，萬達生物製藥盤前股價重挫近12%

BUZZ-美國 FDA 駁回時差藥申請，旺達跌停

萬達生物製藥宣佈收到美國食品藥品監督管理局關於Hetlioz®時差障礙補充新藥申請的決定函

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当长途旅行扰乱了人体的内部时钟，导致疲劳和睡眠不佳时，就会出现时差现象。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:20260303:nL4T3ZR19F:1","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"1146152400","title":"萬達生物製藥宣佈美國FDA為Hetlioz®時差障礙適應症召開里程碑式聽證會，系40餘年來首次新藥審批聽證","url":"https://stock-news.laohu8.com/highlight/detail?id=1146152400","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1146152400?lang=zh_tw&edition=fundamental","pubTime":"2026-03-03 21:04","pubTimestamp":1772543085,"startTime":"0","endTime":"0","summary":"万达生物制药宣布，美国食品药品监督管理局已为其药物Hetlioz®用于治疗时差障碍的申请召开了一次具有里程碑意义的听证会。此次听证会是FDA超过40年来首次针对新药审批举行的听证会，标志着监管程序的一个重要突破。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"1119330741","title":"EMA人用醫藥產品委員會：萬達生物製藥的伊洛哌酮獲負面意見 用於精神分裂症治療","url":"https://stock-news.laohu8.com/highlight/detail?id=1119330741","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1119330741?lang=zh_tw&edition=fundamental","pubTime":"2026-02-27 18:54","pubTimestamp":1772189699,"startTime":"0","endTime":"0","summary":"欧洲药品管理局人用医药产品委员会对万达生物制药旗下药物伊洛哌酮治疗精神分裂症的申请出具了否定性评估意见。该决定意味着该药物现阶段未获得委员会推荐批准。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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","VNDA"],"gpt_icon":0},{"id":"1138725313","title":"萬達生物製藥盤前股價上漲2.3%，FDA受理其罕見皮膚病藥物審查申請","url":"https://stock-news.laohu8.com/highlight/detail?id=1138725313","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1138725313?lang=zh_tw&edition=fundamental","pubTime":"2026-02-25 21:39","pubTimestamp":1772026751,"startTime":"0","endTime":"0","summary":"万达生物制药股价在盘前交易中录得2.3%的上涨，此前美国食品药品监督管理局已正式受理该公司针对罕见皮肤病药物的审查申请。这一进展标志着该药物在监管审批流程中迈出了关键一步，为后续可能的市场准入奠定了基础。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"2614082897","title":"BUZZ-FDA接受罕見皮膚病藥物審查申請，萬達股價上漲","url":"https://stock-news.laohu8.com/highlight/detail?id=2614082897","media":"路透中文","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2614082897?lang=zh_tw&edition=fundamental","pubTime":"2026-02-25 20:53","pubTimestamp":1772024027,"startTime":"0","endTime":"0","summary":"BUZZ-FDA接受罕见皮肤病药物审查申请，万达股价上涨2月25日 - ** 万达制药VNDA.O股价盘前上涨5.39%，报8.61美元 ** 制药商称美国FDA接受了其对imsidolimab的审查申请，该药用于治疗泛发性脓疱型银屑病，一种会导致皮肤出现疼痛脓疱、发烧和疲劳的罕见疾病。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":"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:20260225:nL4T3ZL16T:1","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"1130498462","title":"萬達生物製藥宣佈美國FDA受理imsidolimab治療泛發性膿皰型銀屑病的生物製品許可申請","url":"https://stock-news.laohu8.com/highlight/detail?id=1130498462","media":"投资观察","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1130498462?lang=zh_tw&edition=fundamental","pubTime":"2026-02-25 20:41","pubTimestamp":1772023308,"startTime":"0","endTime":"0","summary":"万达生物制药公司宣布，美国食品药品监督管理局已正式受理其候选药物imsidolimab用于治疗泛发性脓疱型银屑病的生物制品许可申请。\nFDA已为该申请设定了目标审评日期为2026年12月12日。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"1177212007","title":"萬達生物製藥宣佈美國FDA受理Imsidolimab治療泛發性膿皰型銀屑病的生物製品許可申請","url":"https://stock-news.laohu8.com/highlight/detail?id=1177212007","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1177212007?lang=zh_tw&edition=fundamental","pubTime":"2026-02-25 20:30","pubTimestamp":1772022603,"startTime":"0","endTime":"0","summary":"万达生物制药近日宣布，其针对泛发性脓疱型银屑病治疗的生物制剂Imsidolimab的生物制品许可申请，已获得美国食品药品监督管理局的正式受理。这一进展标志着该药物向获批上市迈出了关键一步。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"2613782199","title":"BUZZ--美國股票走勢-禮來、達美樂、諾和諾德","url":"https://stock-news.laohu8.com/highlight/detail?id=2613782199","media":"路透中文","labels":["event"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2613782199?lang=zh_tw&edition=fundamental","pubTime":"2026-02-23 21:22","pubTimestamp":1771852942,"startTime":"0","endTime":"0","summary":".N** 礼来公司LLLY.N：BUZZ - 诺和诺德肥胖症药物在哥本哈根试验中表现不佳，导致该公司股价上涨。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:20260223:nL4T3ZJ0WD: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":["MAAY","COIG","CONI","LLY","BK4534","VNDA","ELIL","COIO","LU1551013425.SGD","LLYX","DPZ","IMRA","HL","CONX","ICOI","FBIN","DOCU","ACLX","COII","DE","ELIS","RIOT","LU1629891620.HKD","RTYY","CDE","MARO","LLYZ","SGXZ81514606.USD","FRSH","MNDY","COIW","LU2361044949.HKD","COIA","CONY","MRAL","COYY","MLTX","MRK","LLII","RIOX","VFC","LDOS","LU0210536198.USD","WDAY","FIAT","LU0345781412.USD","IE00BBT3K403.USD"],"gpt_icon":1},{"id":"2613789898","title":"BUZZ-美國 FDA 批准新型抗精神病藥，萬達醫藥一躍而起","url":"https://stock-news.laohu8.com/highlight/detail?id=2613789898","media":"路透中文","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2613789898?lang=zh_tw&edition=fundamental","pubTime":"2026-02-23 19:32","pubTimestamp":1771846325,"startTime":"0","endTime":"0","summary":"2月23日 - ** Vanda Pharmaceuticals VNDA.O股价盘前上涨37%至7.91美元** 周五晚些时候，美国 FDA 批准了  VNDA 用于治疗两种严重精神疾病的药物** 该药名为 Bysanti，是一种抗精神病药，主要用于治疗精神分裂症和急性双相情感障碍。** H.C. Wainwright 分析师表示：\"Bysanti 的市场独占期预计将延长至 2044 年，这为长期创新和患者获益奠定了坚实的基础。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:20260223:nL4T3ZJ0NQ:1","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"2613139662","title":"BUZZ-抗精神病藥物獲 FDA 批准後，萬達業績大漲","url":"https://stock-news.laohu8.com/highlight/detail?id=2613139662","media":"路透中文","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2613139662?lang=zh_tw&edition=fundamental","pubTime":"2026-02-21 07:35","pubTimestamp":1771630542,"startTime":"0","endTime":"0","summary":"BUZZ-抗精神病药物获 FDA 批准后，万达业绩大涨2月20日 - ** 制药商旺达制药公司VNDA.O的股票在延时交易中上涨34.7%，至7.77美元** 美国FDA批准该公司的抗精神病药物Bysanti上市** 旨在治疗精神分裂症和急性双相情感障碍的药物** 批准该药的同时，FDA 提出了最严重的警告，即老年痴呆症相关精神病患者的死亡风险增加** 2025 年股价上涨 84.1%(为便利非英文母语者，路透将其报导自动化翻译为数种其他语言。","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:20260220:nL4S3ZG1JT:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["VNDA","BK4139"],"gpt_icon":0},{"id":"1189163157","title":"萬達生物製藥更新Bysanti安全警告：老年痴呆相關精神病患者死亡率上升","url":"https://stock-news.laohu8.com/highlight/detail?id=1189163157","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1189163157?lang=zh_tw&edition=fundamental","pubTime":"2026-02-21 07:02","pubTimestamp":1771628539,"startTime":"0","endTime":"0","summary":"万达生物制药公司近日对其药物Bysanti的使用说明进行了重要更新，新增了一项安全警告。该警告指出，在患有痴呆相关精神病的老年患者群体中，使用Bysanti可能导致死亡率增加。\n这一更新是基于最新的临床数据和安全性评估结果。公司强调，医疗专业人员在为这类特定患者群体处方Bysanti时，需仔细权衡其获益与潜在风险。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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","VNDA"],"gpt_icon":0},{"id":"2613218066","title":"美國食品和藥物管理局批准萬達的精神科藥物","url":"https://stock-news.laohu8.com/highlight/detail?id=2613218066","media":"路透中文","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2613218066?lang=zh_tw&edition=fundamental","pubTime":"2026-02-21 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万达制药公司周五表示，美国食品和药物管理局已批准其VNDA.O药物用于治疗两种严重的精神疾病。\n(为便利非英文母语者，路透将其报导自动化翻译为数种其他语言。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:20260220:nL4T3ZG1IV:1","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"1107914472","title":"萬達生物製藥宣佈Bysanti™（米沙哌隆）獲FDA批准用於治療雙相I型障礙和精神分裂症——新化學實體開啓精神科創新新紀元","url":"https://stock-news.laohu8.com/highlight/detail?id=1107914472","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1107914472?lang=zh_tw&edition=fundamental","pubTime":"2026-02-21 07:00","pubTimestamp":1771628411,"startTime":"0","endTime":"0","summary":"万达生物制药宣布，其创新药物Bysanti™（米沙哌隆）已获得美国食品药品监督管理局批准，用于治疗双相I型障碍与精神分裂症。作为全新化学实体，该药物的获批标志着精神疾病治疗领域迎来重大突破，为精神病学创新开辟了全新视野。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"1172660268","title":"萬達生物製藥公布年度營收指引：現有商業化產品收入預計達2.3億至2.6億美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1172660268","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1172660268?lang=zh_tw&edition=fundamental","pubTime":"2026-02-12 05:03","pubTimestamp":1770843790,"startTime":"0","endTime":"0","summary":"万达生物制药近日发布了针对当前已商业化产品的年度财务展望，公司预计其全年营收将落在2.3亿美元至2.6亿美元的区间内。这一指引反映了公司对其核心产品市场表现的信心与预期。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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":["VNDA","BK4139"],"gpt_icon":0},{"id":"2601413395","title":"BUZZ--美國股票走勢-布魯姆能源公司、泰森食品公司、旅行者科技公司","url":"https://stock-news.laohu8.com/highlight/detail?id=2601413395","media":"路透中文","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2601413395?lang=zh_tw&edition=fundamental","pubTime":"2026-01-08 23:44","pubTimestamp":1767887096,"startTime":"0","endTime":"0","summary":"标普500指数.SPX上涨0.01%，报6921.83点；纳斯达克综合指数.IXIC下跌0.46%，报23476.01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:20260108:nL4T3Y9169:1","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":["VNDA","TFX","IE00B19Z3581.USD","RTX","SCCO","CDE","VLO","DLR","TYL","F","LUMN","BW","LU0868494617.USD","GLUE","STZ","NEM","APD","LNN","ARWR","OMDA","GM","SHOO","VOYG","NOC","MLTX","JCAP","HL","NEOG","HELE","DASH","AA","LU0985489474.SGD","SG9999002521.SGD","GAP","MPC","RVMD","DRI","LU0368265764.SGD","KTOS","TSN","COMP","LU1894683348.USD","BE"],"gpt_icon":1},{"id":"1194839696","title":"美國FDA拒絕時差症藥物申請，萬達生物製藥盤前股價重挫近12%","url":"https://stock-news.laohu8.com/highlight/detail?id=1194839696","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1194839696?lang=zh_tw&edition=fundamental","pubTime":"2026-01-08 20:38","pubTimestamp":1767875892,"startTime":"0","endTime":"0","summary":"美国食品药品监督管理局（FDA）正式否决了万达生物制药针对时差症治疗药物的上市申请，这一监管挫折直接冲击了市场信心。\n受此消息影响，万达生物制药股价在盘前交易时段应声下挫，跌幅一度接近12%，反映出投资者对公司短期前景的担忧急剧升温。\n此次FDA的拒绝决定意味着该药物在获批道路上遭遇重大障碍，公司可能需要补充更多临床数据或调整申请策略，从而推迟了潜在商业化时间表。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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","VNDA"],"gpt_icon":0},{"id":"2601746369","title":"BUZZ-美國 FDA 駁回時差藥申請，旺達跌停","url":"https://stock-news.laohu8.com/highlight/detail?id=2601746369","media":"路透中文","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2601746369?lang=zh_tw&edition=fundamental","pubTime":"2026-01-08 20:30","pubTimestamp":1767875435,"startTime":"0","endTime":"0","summary":"BUZZ-美国 FDA 驳回时差药申请，旺达跌停1月8日 - ** 制药商旺达制药VNDA.O股价盘前下跌12.65%，至7.46美元** 该公司称已收到美国食品及药物管理局的一封信，拒绝批准    使用其睡眠药物 Hetlioz 治疗时差反应。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:20260108:nL4S3Y90UF:1","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","VNDA"],"gpt_icon":0},{"id":"1185252065","title":"萬達生物製藥宣佈收到美國食品藥品監督管理局關於Hetlioz®時差障礙補充新藥申請的決定函","url":"https://stock-news.laohu8.com/highlight/detail?id=1185252065","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1185252065?lang=zh_tw&edition=fundamental","pubTime":"2026-01-08 20:10","pubTimestamp":1767874255,"startTime":"0","endTime":"0","summary":"万达生物制药今日宣布，已正式收到美国食品药品监督管理局（FDA）针对其Hetlioz®药物治疗时差障碍的补充新药申请（sNDA）所发出的决定函。\n此次决定函的接收标志着Hetlioz®在拓展适应症方面迈出了关键一步。Hetlioz®是该公司的一款核心产品，此次补充申请旨在将其应用范围延伸至时差障碍的治疗领域。\n公司表示，将仔细评估FDA决定函中的具体内容，并据此确定下一步的研发与申报策略。","market":"us","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":"","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","VNDA"],"gpt_icon":0}],"pageSize":20,"totalPage":3,"pageCount":1,"totalSize":44,"code":"91000000","status":"200"}]}}