美股詳情

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Scholar Rock Holding Corp

50.00

-1.8500-3.57%

盤後：50.170.1700+0.34%19:30 EDT

成交量：525.11萬

成交額：2.54億

市值：60.89億

市盈率：-14.88

高：51.11

開：50.78

低：46.54

收：51.85

52周最高：61.76

52周最低：27.07

股本：1.22億

流通股本：1.08億

量比：2.72

換手率：4.87%

股息：- -

股息率：- -

每股收益(TTM):-3.3601

每股收益(LYR):-3.4845

淨資產收益率：-167.77%

總資產收益率：-58.82%

市淨率：23.99

市盈率(LYR):-14.35

資料載入中...

總覽公司新聞資訊公告

BUZZ——美國股市動態-美國能源股、鮑德温、強生

Scholar Rock高管稱其首款治療脊髓性肌萎縮肌肉流失的藥物，單瓶批發採購成本為11,659美元——電話會議披露

Scholar Rock高管：美國典型患者年度淨治療費用預計約31萬美元

Scholar Rock股價因FDA批准首款肌肉靶向SMA療法而上漲

Scholar Rock獲FDA批准首款肌肉靶向遺傳病藥物，盤前股價飆升11.6%

Scholar Rock重磅宣佈：FDA批准Isembyld™（Apitegromab-Mstn）上市，成為首個且唯一針對脊髓性肌萎縮症（SMA）兒童與成人患者的肌肉靶向療法

Scholar Rock Holding Corporation——Isembyld美國商業上市正式啓動，產品即將發貨

美國食品藥品監督管理局（FDA）批准了Scholar Rock公司的一款治療肌肉無力症的藥物

Scholar Rock旗下Apitegromab獲FDA快速通道資格，面肩肱型肌營養不良症二期試驗啓動給藥

Scholar Rock撤回了針對肌肉無力藥物的歐洲申報，計劃重新提交

Scholar Rock控股公司獲日本PMDA認可，無需補充臨床研究；計劃2026年底提交Apitegromab上市申請

Scholar Rock Holding公司撤回歐洲上市申請，計劃以替代灌裝生產線重新提交

Scholar Rock Holding Corp：蓄勢待發，靜候FDA批准，Apitegromab擬於2026年9月30日PDUFA日期登陸美國市場

美國研究綜述-愛彼迎、Five Below、Silgan Holdings

美國研究綜述-愛彼迎、Five Below、Silgan Holdings

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

Scholar Rock 因FDA質控警告，將諾和諾德工廠從藥物申請中剔除

Scholar Rock Holding Corporation 已全面就緒，只待FDA批准即刻啓動Apitegromab美國上市

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

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

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Rock高管稱其首款治療脊髓性肌萎縮肌肉流失的藥物，單瓶批發採購成本為11,659美元——電話會議披露","url":"https://stock-news.laohu8.com/highlight/detail?id=1148726980","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1148726980?lang=zh_tw&edition=fundamental","pubTime":"2026-09-14 20:28","pubTimestamp":1789388926,"startTime":"0","endTime":"0","summary":"Scholar Rock高管在电话会议中透露，公司首款针对脊髓性肌萎缩所致肌肉流失的药物，其单次使用药瓶的批发采购成本定为11,659美元。这一价格信息源自公司高管的电话会议发言。该药物作为Scholar Rock的首个产品，旨在应对脊髓性肌萎缩患者面临的肌肉流失问题。此定价策略的披露，为市场提供了关于该新药商业化初期成本结构的关键参考。这一数字的公布，凸显了公司在定价方面的初步决策。","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["THNR","SRRK","BK4139","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1171544064","title":"Scholar Rock高管：美國典型患者年度淨治療費用預計約31萬美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1171544064","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1171544064?lang=zh_tw&edition=fundamental","pubTime":"2026-09-14 20:28","pubTimestamp":1789388922,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corp（SRRK）高管表示，公司预计在美国市场，典型患者每年的净治疗费用将接近31万美元。这一预期数字揭示了该疗法的定价策略及其对患者经济负担的潜在影响。","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":["SRRK","BK4139","THNR","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2667503616","title":"Scholar Rock股價因FDA批准首款肌肉靶向SMA療法而上漲","url":"https://stock-news.laohu8.com/highlight/detail?id=2667503616","media":"路透中文","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2667503616?lang=zh_tw&edition=fundamental","pubTime":"2026-09-14 18:41","pubTimestamp":1789382482,"startTime":"0","endTime":"0","summary":"BUZZ-Scholar Rock股价因FDA批准首款肌肉靶向SMA疗法而上涨9月14日-** Scholar Rock股价在盘前交易中上涨10.1%，至61美元** 美国食品药品监督管理局已批准  公司药物Isembyld，作为首款肌肉靶向脊髓性肌萎缩症治疗药物。","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:20260914:nL4S4560P3:1","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":["IBRN","BK4139","THNR","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1141592575","title":"Scholar Rock獲FDA批准首款肌肉靶向遺傳病藥物，盤前股價飆升11.6%","url":"https://stock-news.laohu8.com/highlight/detail?id=1141592575","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1141592575?lang=zh_tw&edition=fundamental","pubTime":"2026-09-14 18:28","pubTimestamp":1789381708,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corp盘前交易中股价大幅上涨11.6%。这一显著涨幅源于美国食品药品监督管理局(FDA)对其首款肌肉靶向药物的批准决定。该药物专为治疗某种特定类型的遗传性疾病而设计，标志着公司在罕见病治疗领域迈出了重要一步。","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":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IBRN","THNR","BK4139","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1198447746","title":"Scholar Rock重磅宣佈：FDA批准Isembyld™（Apitegromab-Mstn）上市，成為首個且唯一針對脊髓性肌萎縮症（SMA）兒童與成人患者的肌肉靶向療法","url":"https://stock-news.laohu8.com/highlight/detail?id=1198447746","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1198447746?lang=zh_tw&edition=fundamental","pubTime":"2026-09-12 06:26","pubTimestamp":1789165582,"startTime":"0","endTime":"0","summary":"Scholar Rock公司今日正式宣告，美国食品药品监督管理局已批准其创新药物Isembyld上市。这一里程碑式的决定，标志着该药物成为全球首个且唯一的肌肉靶向治疗手段，专门面向脊髓性肌萎缩症患者群体——无论是儿童还是成人，均适用此疗法。与现有治疗方案相比，Isembyld独辟蹊径，直接作用于肌肉组织本身，而非仅仅靶向神经系统通路。Scholar Rock方面表示，此次FDA的审批通过，凝聚了公司多年来的科研心血与临床试验成果。","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":["IBRN","SRRK","BK4139","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1146877625","title":"Scholar Rock Holding Corporation——Isembyld美國商業上市正式啓動，產品即將發貨","url":"https://stock-news.laohu8.com/highlight/detail?id=1146877625","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1146877625?lang=zh_tw&edition=fundamental","pubTime":"2026-09-12 06:26","pubTimestamp":1789165570,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corporation宣布，其旗下产品Isembyld在美国的商业上市进程已正式拉开帷幕。目前，该产品已处于可发运状态，预计将在未来数日内陆续送达相关渠道。这一里程碑式的进展，标志着公司在商业化道路上迈出了坚实的一步。据悉，产品现已准备就绪，即将进入物流配送环节，以满足市场预期需求。","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","THNR","SRRK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2666257258","title":"美國食品藥品監督管理局（FDA）批准了Scholar Rock公司的一款治療肌肉無力症的藥物","url":"https://stock-news.laohu8.com/highlight/detail?id=2666257258","media":"路透中文","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2666257258?lang=zh_tw&edition=fundamental","pubTime":"2026-09-12 05:25","pubTimestamp":1789161915,"startTime":"0","endTime":"0","summary":"美国食品药品监督管理局（FDA）批准了Scholar Rock公司的一款治疗肌肉无力症的药物路透9月11日-美国食品和药物管理局（FDA）周五批准了Scholar Rock公司开发的SRRK.O疗法，用于治疗一种会导致肌肉无力的罕见遗传性疾病。","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:20260911:nL4T4531I4:1","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":["LU0109394709.USD","THNR","BMED","BIIB","BK4533","IE00B19Z9P08.USD","IBRN","BK4588","BK4139","LU0320765992.SGD","LU0889565916.HKD","SRRK","BK4585","IE00B19Z9Z06.USD","IE00B894F039.SGD","BK4532","LU0234570918.USD","PBE"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1135653463","title":"Scholar Rock旗下Apitegromab獲FDA快速通道資格，面肩肱型肌營養不良症二期試驗啓動給藥","url":"https://stock-news.laohu8.com/highlight/detail?id=1135653463","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1135653463?lang=zh_tw&edition=fundamental","pubTime":"2026-09-02 20:01","pubTimestamp":1788350501,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corp宣布，其针对面肩肱型肌营养不良症的在研药物Apitegromab已获得美国食品药品监督管理局的快速通道认定。与此同时，该药物的二期FORGE试验已正式启动受试者给药。这一里程碑式的进展标志着Scholar Rock在攻克这一罕见神经肌肉疾病方面迈出了关键一步。值得注意的是，FSHD是一种进行性加重的肌肉萎缩疾病，目前临床上缺乏有效的治疗手段。Apitegromab作为一种潜在的首创疗法，其研发进展备受业界关注。","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","IBRN","SRRK","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661729986","title":"Scholar Rock撤回了針對肌肉無力藥物的歐洲申報，計劃重新提交","url":"https://stock-news.laohu8.com/highlight/detail?id=2661729986","media":"路透中文","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661729986?lang=zh_tw&edition=fundamental","pubTime":"2026-08-21 22:48","pubTimestamp":1787323684,"startTime":"0","endTime":"0","summary":"Scholar Rock撤回了针对肌肉无力药物的欧洲申报，计划重新提交路透8月21日-Scholar Rock公司SRRK.O周五表示，已撤回其针对一种实验性脊髓性肌萎缩症药物的欧洲上市申请，并计划在诺和诺德旗下工厂出现问题后，选择其他生产基地重新提交申请NOVOb.CO。Scholar Rock表示，公司已将其美国FDA申请中涉及的印第安纳州生产基地移除，并继续预期监管机构将在9月30日的目标行动日期前作出批准决定。","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:20260821:nL4T44I0W4:1","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":["SRRK","BK4139","THNR","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1132368667","title":"Scholar Rock控股公司獲日本PMDA認可，無需補充臨床研究；計劃2026年底提交Apitegromab上市申請","url":"https://stock-news.laohu8.com/highlight/detail?id=1132368667","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1132368667?lang=zh_tw&edition=fundamental","pubTime":"2026-08-21 21:12","pubTimestamp":1787317946,"startTime":"0","endTime":"0","summary":"Scholar Rock控股公司迎来重大利好——日本药品和医疗器械管理局（PMDA）已明确表态，认为无需再进行额外的临床研究。这一进展为该公司旗下在研药物Apitegromab的日本上市之路扫清了关键障碍。据此，Scholar Rock计划于2026年底前正式向PMDA提交该药物的上市许可申请（JNDA）。此举标志着公司在全球战略布局中迈出了坚实一步，尤其在亚太核心市场的推进节奏上，展现出明确的执行力与前瞻性。","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":["THNR","SRRK","BK4139","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1162355391","title":"Scholar Rock Holding公司撤回歐洲上市申請，計劃以替代灌裝生產線重新提交","url":"https://stock-news.laohu8.com/highlight/detail?id=1162355391","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1162355391?lang=zh_tw&edition=fundamental","pubTime":"2026-08-21 21:12","pubTimestamp":1787317928,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corporation宣布，已主动撤回其药物Apitegromab在欧洲的上市许可申请。这一决定并非基于任何安全性或有效性方面的顾虑，而是源于生产环节中的具体问题。公司表示，将转而采用另一条灌装生产线，并计划在调整完成后重新提交申请。Scholar Rock管理层在声明中表达了对项目前景的信心，并承诺将与欧洲监管机构保持密切沟通，以确保后续流程高效推进。","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":["IBRN","BK4139","THNR","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1158808120","title":"Scholar Rock Holding Corp：蓄勢待發，靜候FDA批准，Apitegromab擬於2026年9月30日PDUFA日期登陸美國市場","url":"https://stock-news.laohu8.com/highlight/detail?id=1158808120","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1158808120?lang=zh_tw&edition=fundamental","pubTime":"2026-08-21 21:10","pubTimestamp":1787317810,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding Corp已经做好全面准备，一旦获得美国食品药品监督管理局的批准，其药物Apitegromab即刻启动在美国市场的上市进程。这一关键节点锁定在2026年9月30日的《处方药使用者付费法案》目标日期。公司上下正厉兵秣马，为这一刻的到来铺平道路。届时，Apitegromab将迅速投放市场，惠及广大患者。这一战略部署彰显了公司对产品获批的坚定信心，也体现了其对市场需求的敏锐把握。随着PDUFA日期的临近，一场精心筹备的市场登陆战即将拉开帷幕。","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","SRRK","BK4139","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2659713954","title":"美國研究綜述-愛彼迎、Five Below、Silgan Holdings","url":"https://stock-news.laohu8.com/highlight/detail?id=2659713954","media":"路透中文","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2659713954?lang=zh_tw&edition=fundamental","pubTime":"2026-08-13 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Holdings。股票按字母顺序排列。","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:20260813:nL4T44A0GC: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":["CSCO","TRAX","IXJ","OII","PAYX","FIVE","LLY","SLGN","TRUH","UNCY","INSW","HRTS","OI","AGNG","ABNB","INO","Z","PTCT","MTSI","ZG","ARMK","RHP","FLY","MNPR","YELP","ALGM","IHE","COHX","EAT","DUOL","AMTM","OSCR","ACM","COHR","HP","LOW","SPHR","ILDR","KURA","XES","SRRK","ANRO","CAH","LQDA","PARK","MNSH","TRIP","MSGE","AMRZ","CYTK"],"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":["SRRK","IBRN","BK4139","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":"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":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IE00BKVL7J92.USD","NVO","PPH","NVOH","BK4139","LU0154236417.USD","BK4585","BK4007","LU1093756168.USD","BK4599","THNR","OZEM","SRRK","IBRN","IE00BZ1G4Q59.USD","NVOX","BK4532","BK4588","LU1093756325.SGD"],"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":["THNR","SRRK","BK4139","IBRN"],"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":["BK4139","IBRN","SRRK","THNR"],"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":["SRRK","BK4139","THNR","IBRN"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":2,"pageCount":1,"totalSize":34,"code":"91000000","status":"200"}]}}