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AMPLIFY WEIGHT LOSS DRUG & TREATMENT ETF
25.37
-0.0975
-0.38%
盤後:
25.29
-0.0763
-0.30%
16:10 EDT
成交量:
860
成交額:
2.18萬
市值:
583.42萬
市盈率:
- -
高:
25.72
開:
25.72
低:
25.29
收:
25.46
52周最高:
27.94
52周最低:
22.63
股本:
23.00萬
流通股本:
23.00萬
量比:
1.35
換手率:
0.37%
股息:
0.41
股息率:
1.63%
淨資產收益率:
--
總資產收益率:
--
市淨率:
--
市盈率(LYR):
- -
資料載入中...
總覽
公司
新聞資訊
公告
Hims & Hers Health提前測試肽類成分,靜待FDA關於允許藥物配製的決定——電話會議透露
美股速递
·
08/11
Hims & Hers Health:CFO稱國際業務與減肥產品拖累Q2利潤率
美股速递
·
08/11
Hims & Hers Health CFO:若現行法規允許,有信心快速擴大肽類產品規模
美股速递
·
08/11
「Hims and Hers」股價上漲,因上調業績預期且季度營收增長
路透中文
·
08/11
Hims & Hers Health Inc.:預計AI投資將在12至18個月內實現自我回報,並有望讓產品對客户更實惠
美股速递
·
08/11
Hims & Hers Health:預計其國內業務將在下半年持續加速增長
美股速递
·
08/11
得益於訂閲用户數量的強勁增長,Hims & Hers 季度營收實現增長
路透中文
·
08/11
Hims & Hers Health:對2030年至少65億美元營收及13億美元調整後EBITDA目標信心倍增
美股速递
·
08/11
數據簡報-全球製藥企業斥資數十億以擴大在美國的市場份額
路透中文
·
08/10
諾和諾德與亞馬遜AWS建立戰略合作伙伴關係 推動通過人工智能加速藥物研發
格隆汇
·
08/10
亞馬遜公司:諾和諾德選定 AWS 作為合作伙伴。
智通财经
·
08/10
諾和諾德(NVO.US):各方人士在倫敦共同打造了一個創新中心。該合作將利用人工智能作為諾和諾德的創新驅動力。
智通财经
·
08/10
禮來減肥藥在英國獲歐洲首項批准
路透中文
·
08/10
英國批准禮來的 Foundayo 用於體重管理及 2 型糖尿病治療。
智通财经
·
08/10
伯恩斯坦將諾和諾德目標價從200丹麥克朗上調至203丹麥克朗。
智通财经
·
08/10
更正-Scholar Rock將諾和諾德的生產設施從肌肉無力藥物的上市申請中剔除
路透中文
·
08/08
Scholar Rock 因FDA質控警告,將諾和諾德工廠從藥物申請中剔除
投资观察
·
08/08
Scholar Rock Holding Corporation 已全面就緒,只待FDA批准即刻啓動Apitegromab美國上市
美股速递
·
08/08
Scholar Rock宣佈FDA受理Apitegromab治療脊髓性肌萎縮症(SMA)的生物製品許可申請(BLA),並推進第二家灌裝-封裝工廠建設;預計2026年9月30日前作出審批決定
美股速递
·
08/08
Scholar Rock Holding Corp 與歐洲藥品管理局溝通,計劃將第二家灌裝-封裝設施納入Apitegromab上市申請
美股速递
·
08/08
更多
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Health提前測試肽類成分,靜待FDA關於允許藥物配製的決定——電話會議透露","url":"https://stock-news.laohu8.com/highlight/detail?id=1124573842","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1124573842?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 05:20","pubTimestamp":1786396838,"startTime":"0","endTime":"0","summary":"在即将到来的FDA关键决策之前,Hims & Hers Health Inc.已悄然展开肽类成分的测试工作。这家健康科技公司正密切关注监管机构是否允许针对这些药物进行配制。","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":["HIMS","GLAM","BK4196","HIYY","HMYY","THNR","HIMY","HIMZ","HEAL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1168471363","title":"Hims & Hers Health:CFO稱國際業務與減肥產品拖累Q2利潤率","url":"https://stock-news.laohu8.com/highlight/detail?id=1168471363","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1168471363?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:56","pubTimestamp":1786395415,"startTime":"0","endTime":"0","summary":"Hims & Hers Health Inc. 首席财务官坦言,国际业务拓展以及减肥产品的销售,在第二季度拉低了公司的整体利润率。这些领域的运营特征,与核心业务相比,呈现出不同的盈利表现。","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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HEAL","HIYY","HIMZ","BK4196","THNR","HIMY","GLAM","HIMS","HMYY"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1192063839","title":"Hims & Hers Health CFO:若現行法規允許,有信心快速擴大肽類產品規模","url":"https://stock-news.laohu8.com/highlight/detail?id=1192063839","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1192063839?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:44","pubTimestamp":1786394681,"startTime":"0","endTime":"0","summary":"Hims & Hers Health Inc. 首席财务官表示,公司对在现行法规允许的情况下快速扩大其肽类产品供应规模充满信心。","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":["BK4196","GLAM","HMYY","THNR","HIYY","HEAL","HIMS","HIMZ","HIMY"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2658590369","title":"「Hims and Hers」股價上漲,因上調業績預期且季度營收增長","url":"https://stock-news.laohu8.com/highlight/detail?id=2658590369","media":"路透中文","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2658590369?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:21","pubTimestamp":1786393262,"startTime":"0","endTime":"0","summary":"BUZZ-“Hims and Hers”股价上涨,因上调业绩预期且季度营收增长8月10日-** 远程医疗公司 Hims & Hers(HIMS.N)的股价在盘后交易中上涨 3%,报 33 美元**得益于订阅用户数量增长及个性化医疗服务范围的扩大,HIMS公布第二季度营收增长(link),并上调全年业绩预期** 据伦敦证券交易所集团(LSEG)汇编的数据,该公司第二季度营收为7.53亿美元,而去年同期为5.44亿美元;分析师此前预计营收为6.9989亿美元**将2026财年营收预期从之前的28亿至30亿美元区间上调至31亿至33亿美元** 计入当日交易波动,该股年初至今累计下跌2.2%","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:20260810:nL4T4471FP:1","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":["HIYY","HMYY","HEAL","HIMS","HIMY","BK4196","GLAM","THNR","HIMZ"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1137770526","title":"Hims & Hers Health Inc.:預計AI投資將在12至18個月內實現自我回報,並有望讓產品對客户更實惠","url":"https://stock-news.laohu8.com/highlight/detail?id=1137770526","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1137770526?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:11","pubTimestamp":1786392685,"startTime":"0","endTime":"0","summary":"Hims & Hers Health Inc. 预计其在人工智能领域的投资,将在12至18个月内实现自我回报。公司还预期,这些投入将有助于使其产品和服务对客户而言更加亲民、更具性价比。","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":["BK4196","GLAM","HMYY","THNR","HIYY","HEAL","HIMS","HIMZ","HIMY"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1169345584","title":"Hims & Hers Health:預計其國內業務將在下半年持續加速增長","url":"https://stock-news.laohu8.com/highlight/detail?id=1169345584","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1169345584?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:09","pubTimestamp":1786392543,"startTime":"0","endTime":"0","summary":"Hims & Hers Health Inc. 表示,预计其国内业务将在今年下半年继续加速扩张。这一乐观展望,凸显了公司对自身增长轨迹的坚定信心。随着市场对其健康解决方案的需求持续攀升,该企业正积极准备迎接新一轮业绩高峰。从当前态势看,其国内业务不仅有望维持强劲势头,更可能进一步突破预期,为整体财务表现注入源源不断的动力。","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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["GLAM","BK4196","HIMY","HMYY","HIMZ","HIYY","HIMS","THNR","HEAL"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2658959351","title":"得益於訂閲用户數量的強勁增長,Hims & Hers 季度營收實現增長","url":"https://stock-news.laohu8.com/highlight/detail?id=2658959351","media":"路透中文","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2658959351?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:08","pubTimestamp":1786392507,"startTime":"0","endTime":"0","summary":"得益于订阅用户数量的强劲增长,Hims & Hers 季度营收实现增长路透纽约8月10日-远程医疗公司Hims & Hers Health(HIMS.N)周一公布了第二季度营收增长,这得益于订阅用户数量的增加以及个性化医疗服务范围的扩大。该公司报告称,本季度营收为7.53亿美元,而去年同期为5.44亿美元。据伦敦证券交易所集团(LSEG)汇编的数据,分析师此前预计营收为6.9989亿美元。","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:20260810:nL4S4471EX: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":["BK4196","HEAL","GLAM","THNR","HMYY","HIMZ","HIMS","HIMY","HIYY"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1131347768","title":"Hims & Hers Health:對2030年至少65億美元營收及13億美元調整後EBITDA目標信心倍增","url":"https://stock-news.laohu8.com/highlight/detail?id=1131347768","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1131347768?lang=zh_tw&edition=fundamental","pubTime":"2026-08-11 04:07","pubTimestamp":1786392455,"startTime":"0","endTime":"0","summary":"Hims & Hers Health Inc.正日益坚定地看好其2030年发展蓝图。该公司如今对实现至少65亿美元营收与13亿美元调整后EBITDA的远期目标,抱有愈发强烈的信心。这一雄心勃勃的规划,彰显了管理层对长期增长轨迹的笃定,以及公司战略执行力的持续强化。","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":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["HIMZ","HIMY","HEAL","GLAM","HIMS","THNR","BK4196","HIYY","HMYY"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2658931998","title":"數據簡報-全球製藥企業斥資數十億以擴大在美國的市場份額","url":"https://stock-news.laohu8.com/highlight/detail?id=2658931998","media":"路透中文","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2658931998?lang=zh_tw&edition=fundamental","pubTime":"2026-08-10 21:18","pubTimestamp":1786367928,"startTime":"0","endTime":"0","summary":"数据简报-全球制药企业斥资数十亿以扩大在美国的市场份额修改发稿日期,补充百时美施贵宝的投资计划路透8月10日-全球制药企业正扩大在美国的业务布局,承诺投入数十亿美元以提升该国的生产能力和研发实力。该公司于6月表示,已在佛罗里达州杰克逊维尔投资约10亿美元,以加强其眼科护理业务在美国的制造能力。赛诺菲计划通过直接投资公司现有基地以及与其他国内制造商建立合作伙伴关系,扩大其在美国的生产能力。","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:20260810:nL4T4470YN: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":["LU0820561909.HKD","LU2271345857.HKD","LU0471298777.SGD","LU0353189763.USD","LU1074936037.SGD","SG9999014898.SGD","LU0208291251.USD","LU0306806265.USD","AZN","BK7508","LU0949170772.SGD","LU0057025933.USD","LU0965509283.SGD","LU2430703251.USD","LU2471134879.HKD","LU1623119135.USD","LU2237443465.HKD","LU0210528500.USD","LU1548497426.USD","LU0795875169.SGD","LU0471298694.HKD","IHE","LU2236285917.USD","LU0211331839.USD","LU2433249047.HKD","BK4566","LU0225283273.USD","LU0708995401.HKD","LU0889565916.HKD","LU1232071149.USD","LU1228905037.USD","LU1935042991.SGD","THNR","GLAM","LU0792757196.USD","LU2106854487.HKD","LU0868494708.USD","IE00BWXC8680.SGD","LU2023251221.USD","LU1551013342.USD","IE00B1XK9C88.USD","LU2357305700.SGD","LU0234572021.USD","LU2357627491.SGD","AZNH","LU0994945656.USD","LU2237443382.USD","LU2750360641.GBP","BK4139","SG9999015978.USD","LLII","LU1291159041.SGD","LU0345769128.USD","IE00BFXG1179.USD","LU0225771236.USD","LU0426417589.USD","LU2361044949.HKD","GSK","SG9999018865.SGD","LU0965509101.SGD","LU0823434740.USD","LU0072461881.USD","LU1366192091.USD","LU0130102774.USD","SG9999001176.USD","IE00BJJMRX11.SGD","LU0158827948.USD","LU0237698245.USD","IE00BZ1G4Q59.USD","IE00B2B36J28.USD","LU2430703178.SGD","LU2592432038.USD","SG9999014567.USD","LU0859254822.USD","IE00B1BXHZ80.USD","LU0265550359.USD","SG9999013999.USD","JDOC","LU0965508806.USD","LU1201861249.SGD","LU2087625088.SGD","LU2242646821.SGD","BK4532","LU0265550946.USD","LU0417517546.SGD","BIIB","LU2264538146.SGD","LU0511384066.AUD","LU0106261372.USD","LU2129689605.HKD","IE0000B7K699.USD","LU1032955483.USD","BMED","GSKH","LU0310800379.SGD","LU0321505439.SGD","SG9999001176.SGD","LU1267930573.SGD","04332","LU1988902786.USD","LU0203347892.USD","LU1057294990.SGD","LU1720051017.SGD","LU1929549753.HKD","SGXZ57979304.SGD","IE00B42XCP33.USD","LU0787776722.HKD","LU1121112475.USD","MEDX","LU2468319806.SGD","LU1061106388.HKD","LU0029864427.USD","LU1069347547.HKD","LU0320765992.SGD","SG9999011175.SGD","JNJ","LU1571399168.USD","LU0203201768.USD","LU1941712264.USD","LU1670627923.USD","LU2487616109.SGD","LU0661504455.SGD","IE00BJLML261.HKD","IE000F7OJYX1.SGD","XLV","IE00BLSP4239.USD","LU0477156953.USD","LU1699723380.USD","LU2112291526.USD","BK4550","LU2461242641.AUD","LU1069344957.HKD","IE00BJJMRZ35.SGD","LU1585245621.USD","LU1244550221.USD","LU0211328371.USD","LU1868836591.USD","LU0708994859.HKD","LU1629891620.HKD","LU2211815571.USD","SG9999014542.SGD","LU0070217475.USD","IE00BGHQF631.EUR","SG9999003800.SGD","BMY","SG9999015986.USD","VHT","LU1145028129.USD","LU1196500208.SGD","LU0098860793.USD","LU2596442595.SGD","LU2361045086.USD","LU1064131342.USD","LU0912757837.SGD","LU2168563687.JPY","LU0130517989.USD","LU0354030511.USD","HRTS","LU1035775433.USD","BIB","LU0868494617.USD","LU2265009873.SGD","LU2756315664.SGD","LU1941712348.USD","LU0689626769.HKD","LU0203345920.USD","IXJ","IE00B894F039.SGD","LU0289739699.SGD","IE00BKVL7J92.USD","LU1261432733.SGD","LU0553294199.USD","LU1066051811.HKD","LU0882574055.USD","LU0795875086.SGD","LU0053666078.USD","SG9999002232.USD","IE00BSNM7G36.USD","LU1934455194.USD","LU2063271972.USD","BK4588","LU0965509010.AUD","LU2360106947.USD","LU1066053197.SGD","LU0266013472.USD","LU1221951129.SGD","LU1496350171.SGD","LU0109394709.USD","LU1732799900.SGD","LU0174119429.USD","SG9999014880.SGD","LU2168564222.USD","LU1244550577.SGD","IE00BKPKM429.USD","LU1989772840.SGD","BK4568","LU0466842654.USD","BBH","LU2125154778.USD","LU2129689431.USD","LU2462591350.SGD","SG9999017495.SGD","IE00BFSS8Q28.SGD","LU0640476718.USD","ILDR","IE0004445015.USD","LU1228905540.USD","LU2417539215.USD","LU2471134952.CNY","MHIP","IE0001KFT4U8.USD","LU2471134796.USD","LU0882574139.USD","LU1267930730.SGD","LU1778281490.HKD","LU1934455863.HKD","NVO","CANC","LU0069063385.USD","SG9999002224.SGD","LU1974910355.USD","LU0345769631.USD","BK4599","LU0310799852.SGD","SG9999014575.USD","LU0345770993.USD","LU1162221912.USD","ELIS","LU1670711040.USD","LU2089984988.USD","LU2237443895.HKD","LU1116320737.USD","LU1244550494.USD","LU0942090050.USD","LLYX","LU2129689514.USD","LU1829250122.USD","NVOX","IE00BKDWB100.SGD","LU1267930490.SGD","LU0648001328.SGD","BK4581","LU0726765562.USD","LU0320765059.SGD","IE00B7SZLL34.SGD","IE00BBT3K403.USD","IE00B7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15:57","pubTimestamp":1786348653,"startTime":"0","endTime":"0","summary":null,"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://www.zhitongcaijing.com/immediately.html?type=usstock","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":"live_zhitongcaijing","symbols":["OZEM","PPH","BK4007","IE00BKVL7J92.USD","LU1093756325.SGD","BK4532","THNR","BK4599","BK4588","LU1093756168.USD","NVOH","LU0154236417.USD","NVO","BK4585","NVOX","IE00BZ1G4Q59.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2657629774","title":"更正-Scholar Rock將諾和諾德的生產設施從肌肉無力藥物的上市申請中剔除","url":"https://stock-news.laohu8.com/highlight/detail?id=2657629774","media":"路透中文","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2657629774?lang=zh_tw&edition=fundamental","pubTime":"2026-08-08 05:28","pubTimestamp":1786138136,"startTime":"0","endTime":"0","summary":"更正-Scholar Rock将诺和诺德的生产设施从肌肉无力药物的上市申请中剔除更正:标题和第一段中应为诺和诺德位于印第安纳州的工厂,而非卡塔伦特Sneha S K路透8月7日-Scholar Rock公司周五表示,将从其向美国食品药品监督管理局提交的罕见神经肌肉疾病药物审批申请中,移除诺和诺德位于印第安纳州的制造工厂。Scholar Rock表示,该药物的批准决定仍按计划于9月30日作出。","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:20260807:nL4T4441MP: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":["BK4139","SRRK","IBRN","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1181955205","title":"Scholar Rock 因FDA質控警告,將諾和諾德工廠從藥物申請中剔除","url":"https://stock-news.laohu8.com/highlight/detail?id=1181955205","media":"投资观察","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1181955205?lang=zh_tw&edition=fundamental","pubTime":"2026-08-08 04:51","pubTimestamp":1786135897,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding 正从其用于治疗脊髓性肌萎缩症的 apitegromab 生物制剂许可申请中,移除一座由诺和诺德拥有的灌装-封装设施。此举背景是,该设施因可能面临美国食品药品监督管理局的执法行动而被标记。Scholar Rock 透露,公司于周五收到客户通知,称FDA已将首个灌装-封装设施——即诺和诺德旗下的Catalent Indiana——在4月的一次现场检查后,归类为“官方行动指示”。“Scholar Rock 将继续与FDA密切合作,并遵循其指导,将Catalent Indiana从apitegromab的BLA中移除,”公司表示。","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":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["THNR","NVO","LU0154236417.USD","BK4007","OZEM","BK4599","SRRK","IBRN","BK4532","BK4588","NVOX","IE00BKVL7J92.USD","PPH","NVOH","LU1093756168.USD","IE00BZ1G4Q59.USD","BK4139","LU1093756325.SGD","BK4585"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1109042786","title":"Scholar Rock Holding Corporation 已全面就緒,只待FDA批准即刻啓動Apitegromab美國上市","url":"https://stock-news.laohu8.com/highlight/detail?id=1109042786","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1109042786?lang=zh_tw&edition=fundamental","pubTime":"2026-08-08 04:21","pubTimestamp":1786134077,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corporation 已做好充分准备。一旦获得美国食品药品监督管理局(FDA)的批准,他们将立即启动Apitegromab在美国市场的上市。该公司正蓄势待发,静候监管绿灯的亮起,以便迅速将这款药物推向市场。","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":["IBRN","BK4139","SRRK","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1180768754","title":"Scholar Rock宣佈FDA受理Apitegromab治療脊髓性肌萎縮症(SMA)的生物製品許可申請(BLA),並推進第二家灌裝-封裝工廠建設;預計2026年9月30日前作出審批決定","url":"https://stock-news.laohu8.com/highlight/detail?id=1180768754","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1180768754?lang=zh_tw&edition=fundamental","pubTime":"2026-08-08 04:21","pubTimestamp":1786134073,"startTime":"0","endTime":"0","summary":"Scholar Rock公司今日宣布,美国食品药品监督管理局(FDA)已正式受理其针对Apitegromab用于治疗脊髓性肌萎缩症(SMA)的生物制品许可申请(BLA)。与此同时,该公司正积极推进第二家灌装-封装工厂的建设。市场预期,FDA将在2026年9月30日的行动日期前作出最终审批决定。","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":["THNR","IBRN","SRRK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1119566389","title":"Scholar Rock Holding Corp 與歐洲藥品管理局溝通,計劃將第二家灌裝-封裝設施納入Apitegromab上市申請","url":"https://stock-news.laohu8.com/highlight/detail?id=1119566389","media":"美股速递","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1119566389?lang=zh_tw&edition=fundamental","pubTime":"2026-08-08 04:21","pubTimestamp":1786134070,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corp 正积极与欧洲药品管理局(EMA)展开沟通。该公司旨在将第二处灌装-封装生产设施,纳入其实验性药物Apitegromab的上市许可申请(MAA)中。这一举措,凸显了其对于扩大生产能力的战略布局。通过此举,公司期望能优化供应链韧性,并确保未来药物获批后的稳定供应。此举不仅关乎生产规模,更体现了对监管流程的深度参与与前瞻性规划。","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":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["THNR","BK4139","SRRK","IBRN"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":10,"pageCount":9,"totalSize":200,"code":"91000000","status":"200"}]}}