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Scholar Rock Holding Corp

56.64

-1.1600-2.01%

Volume:421.87K

Turnover:23.97M

Market Cap:6.90B

PE:-16.86

High:57.62

Open:57.20

Low:56.10

Close:57.80

52wk High:61.76

52wk Low:27.07

Shares:121.79M

Float Shares:107.73M

Volume Ratio:0.38

T/O Rate:0.39%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-3.3601

EPS(LYR):-3.4845

ROE:-167.77%

ROA:-58.82%

PB:27.18

PE(LYR):-16.25

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Overview Company News Filings

Scholar Rock to Present at Cantor Global Healthcare Conference Fireside Chat

Scholar Rock (SRRK) Is Up 8.5% After De-Risking Apitegromab’s Global Filing Pathway - Has The Bull Case Changed?

Simply Wall St.

Scholar Rock's Global Regulatory Path Further De-Risked, Wedbush Says

MT Newswires Live

Wedbush Adjusts Scholar Rock Price Target to $64 From $58, Maintains Outperform Rating

MT Newswires Live

Scholar Rock price target raised to $64 from $58 at Wedbush

Scholar Rock removes Catalent Indiana from apitegromab BLA under FDA guidance

Scholar Rock Holding Corporation - Prepared for U.S. Apitegromab Launch upon FDA Approval by Sept 30, 2026 Pdufa Date

THOMSON REUTERS

Scholar Rock Holding Corporation - Withdraws Apitegromab Maa in Europe; to Resubmit with Alternate Fill-Finish Facility

THOMSON REUTERS

Scholar Rock Holding Corporation - Pmda Agrees no Additional Clinical Studies Required; Scholar Rock to Submit Apitegromab Jnda by Ye 2026

THOMSON REUTERS

Scholar Rock Withdraws EU Apitegromab Filing After FDA Flags Catalent Indiana Plant with OAI Inspection Rating

How Investors Are Reacting To Scholar Rock (SRRK) Dual Fill-Finish Readiness Amid Ongoing FDA Review

Simply Wall St.

Scholar Rock Grants Inducement Equity Awards for 51,947 Shares to 12 New Hires

Scholar Rock Reports New Employee Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

THOMSON REUTERS

Scholar Rock Holding Price Target Raised to $63.00/Share from $56.00 by JP Morgan

Scholar Rock Holding Price Target Maintained with a $65.00/Share by HC Wainwright & Co.

Update: Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date

MT Newswires Live

Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date

MT Newswires Live

Scholar Rock Holdings Pulls Novo Nordisk Facility from Drug Application After FDA Flag

Scholar Rock to remove Catalent Indiana facility from apitegromab BLA

Analysts Have Conflicting Sentiments on These Healthcare Companies: InMode (INMD), GH Research (GHRS) and Scholar Rock Holding (SRRK)

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Rock to Present at Cantor Global Healthcare Conference Fireside Chat","url":"https://stock-news.laohu8.com/highlight/detail?id=2662702532","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2662702532?lang=en_us&edition=fundamental","pubTime":"2026-08-27 20:02","pubTimestamp":1787832131,"startTime":"0","endTime":"0","summary":"Scholar Rock to present at Cantor Global Healthcare Conference fireside chatScholar Rock will join a fireside chat at the Cantor 2026 Global Healthcare Conference on Sept. 9, 2026 at 8:00 a.m. ET.Management will also participate in a fireside chat at the Citi 2026 BioPharma Back to School Conference on Sept. 10, 2026 at 9:20 a.m. ET.Disclaimer:This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Scholar Rock Holding Corporation published the original content used to generate this news brief via Business Wire  on August 27, 2026, and is solely responsible for the information contained therein.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260827:nNDL7wl7kq: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":["IYF","LU1506573853.SGD","LU1668664300.SGD","BK4139","BK4588","BK4207","LU0203345920.USD","LU1244550221.USD","LU0072461881.USD","LU0477156953.USD","LU0052756011.USD","LU0098860793.USD","IE00BSNM7G36.USD","LU0320765646.SGD","LU1244550494.USD","LU1162221912.USD","LU0130102774.USD","IBRN","LU1267930227.SGD","LU0128525689.USD","LU2125154778.USD","LU2462157665.USD","LU1244550577.SGD","FTXO","BK4534","THNR","BK4504","LU1366192091.USD","LU1791807156.HKD","TFNS","BK4559","BK4585","SRRK","LU0106831901.USD","LU1144417596.USD","LU2417539215.USD","LU1074936037.SGD","LU0314106906.USD","LU0310800965.SGD","LU2456880835.USD","LU0130517989.USD","LU0162691827.USD","LU0203347892.USD","LU2125154935.USD","LU0170899867.USD","LU1201861249.SGD","LU2360032135.SGD","LU0648001328.SGD","LU0980610538.SGD","LU2236285917.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661222175","title":"Scholar Rock (SRRK) Is Up 8.5% After De-Risking Apitegromab’s Global Filing Pathway - Has The Bull Case Changed?","url":"https://stock-news.laohu8.com/highlight/detail?id=2661222175","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661222175?lang=en_us&edition=fundamental","pubTime":"2026-08-24 16:20","pubTimestamp":1787559646,"startTime":"0","endTime":"0","summary":"Earlier this week, Scholar Rock announced it had removed Catalent Indiana from all commercial fill-finish roles in apitegromab’s U.S. BLA for spinal muscular atrophy, withdrawn and planned to resubmit its European filing with an alternate facility, and secured PMDA alignment to file a Japanese application without new local trials.\nThis set of regulatory and manufacturing moves materially reduces operational risk around apitegromab’s global rollout by shifting to a compliant U.S. facility...","market":"nz","thumbnail":"https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-srrk/scholar-rock-holding/news/scholar-rock-srrk-is-up-85-after-de-risking-apitegromabs-glo","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-srrk/scholar-rock-holding/news/scholar-rock-srrk-is-up-85-after-de-risking-apitegromabs-glo","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":"simplywall_highlight","symbols":["IBRN","AIPO","SRRK","BK4139","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661292181","title":"Scholar Rock's Global Regulatory Path Further De-Risked, Wedbush Says","url":"https://stock-news.laohu8.com/highlight/detail?id=2661292181","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661292181?lang=en_us&edition=fundamental","pubTime":"2026-08-22 03:03","pubTimestamp":1787339001,"startTime":"0","endTime":"0","summary":"Scholar Rock's  latest update further de-risks the global apitegromab regulatory path, given the potential approval in the US and clear view on the Japan registration path, offsetting a delay in Europe, Wedbush said Friday.Earlier, Scholar Rock confirmed removal of Novo Nordisk's  Catalent Indiana as a commercial fill-finish facility from its US biologics license application, and it expects an approval decision from the US Food and Drug Administration by Sept. 30 for apitegromab as a treatment for spinal muscular atrophy.In Europe, Scholar Rock said it withdrew its marketing authorization application following the Catalent inspection issue and plans to resubmit with the new facility. In Japan, no additional clinical studies are needed, allowing a new drug application filing by year-end.Wedbush reiterated its outperform rating on Scholar Rock's stock and raised its price target to $64 from $58.Price: 56.16, Change: +0.91, Percent Change: +1.64","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["IBRN","THNR","BK4139","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661294877","title":"Wedbush Adjusts Scholar Rock Price Target to $64 From $58, Maintains Outperform Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2661294877","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661294877?lang=en_us&edition=fundamental","pubTime":"2026-08-22 00:45","pubTimestamp":1787330734,"startTime":"0","endTime":"0","summary":"Price: 56.19, Change: +0.94, Percent Change: +1.70","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["BK4139","SRRK","THNR","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661729187","title":"Scholar Rock price target raised to $64 from $58 at Wedbush","url":"https://stock-news.laohu8.com/highlight/detail?id=2661729187","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661729187?lang=en_us&edition=fundamental","pubTime":"2026-08-21 23:40","pubTimestamp":1787326815,"startTime":"0","endTime":"0","summary":"Wedbush raised the firm’s price target on Scholar Rock (SRRK) to $64 from $58 and keeps an Outperform rating on the shares. Published first on TheF...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/scholar-rock-price-target-raised-to-64-from-58-at-wedbush-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/scholar-rock-price-target-raised-to-64-from-58-at-wedbush-thefly-news?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["IBRN","BK4139","SRRK","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661442293","title":"Scholar Rock removes Catalent Indiana from apitegromab BLA under FDA guidance","url":"https://stock-news.laohu8.com/highlight/detail?id=2661442293","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661442293?lang=en_us&edition=fundamental","pubTime":"2026-08-21 21:10","pubTimestamp":1787317815,"startTime":"0","endTime":"0","summary":"Scholar Rock (SRRK) announced it has removed Catalent Indiana (NVO) as a commercial fill-finish facility from its apitegromab Biologics License App...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/scholar-rock-removes-catalent-indiana-from-apitegromab-bla-under-fda-guidance-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/scholar-rock-removes-catalent-indiana-from-apitegromab-bla-under-fda-guidance-thefly-news?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BK4007","IBRN","BK4530","THNR","BK4585","BK4139","BK4588","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661829358","title":"Scholar Rock Holding Corporation - Prepared for U.S. Apitegromab Launch upon FDA Approval by Sept 30, 2026 Pdufa Date","url":"https://stock-news.laohu8.com/highlight/detail?id=2661829358","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661829358?lang=en_us&edition=fundamental","pubTime":"2026-08-21 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2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2661129353","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661129353?lang=en_us&edition=fundamental","pubTime":"2026-08-21 21:07","pubTimestamp":1787317634,"startTime":"0","endTime":"0","summary":null,"market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","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:nFWN44I0ID:3","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":"reuters_en_live","symbols":["IBRN","THNR","SRRK","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2661300293","title":"Scholar Rock Withdraws EU Apitegromab Filing After FDA Flags Catalent Indiana Plant with OAI Inspection Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2661300293","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2661300293?lang=en_us&edition=fundamental","pubTime":"2026-08-21 21:06","pubTimestamp":1787317583,"startTime":"0","endTime":"0","summary":"Scholar Rock withdraws EU apitegromab filing after FDA flags Catalent Indiana plant with OAI inspection ratingScholar Rock removed Catalent Indiana as an apitegromab fill-finish site from its FDA BLA ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","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:nNDL5lyPW: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":["IBRN","SRRK","THNR","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2659173150","title":"How Investors Are Reacting To Scholar Rock (SRRK) Dual Fill-Finish Readiness Amid Ongoing FDA Review","url":"https://stock-news.laohu8.com/highlight/detail?id=2659173150","media":"Simply Wall St.","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2659173150?lang=en_us&edition=fundamental","pubTime":"2026-08-15 21:21","pubTimestamp":1786800069,"startTime":"0","endTime":"0","summary":"In early August 2026, Scholar Rock Holding Corporation reported that its second-quarter net loss was US$109.9 million, slightly lower than a year earlier, while its six-month net loss widened to US$215.41 million and loss per share stayed broadly similar.\nAt the same time, the company highlighted that its apitegromab biologics license application for spinal muscular atrophy remains under active FDA review with two independent fill-finish facilities prepared to support potential approval and...","market":"sg","thumbnail":"https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice2-main-header/1585186599552"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-srrk/scholar-rock-holding/news/how-investors-are-reacting-to-scholar-rock-srrk-dual-fill-fi","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-srrk/scholar-rock-holding/news/how-investors-are-reacting-to-scholar-rock-srrk-dual-fill-fi","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":"simplywall_highlight","symbols":["LABU","BK4588","BK4585","BK4139","THNR","SRRK","BK4211","ISBC","IBRN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2659129349","title":"Scholar Rock Grants Inducement Equity Awards for 51,947 Shares to 12 New Hires","url":"https://stock-news.laohu8.com/highlight/detail?id=2659129349","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2659129349?lang=en_us&edition=fundamental","pubTime":"2026-08-15 04:15","pubTimestamp":1786738521,"startTime":"0","endTime":"0","summary":"Scholar Rock grants inducement equity awards for 51,947 shares to 12 new hiresScholar Rock granted inducement equity awards covering 51,947 common shares to 12 newly hired employees under its 2022 Ind","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260814:nNDL6LXLYl: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":["IBRN","BK4139","THNR","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2659293951","title":"Scholar Rock Reports New Employee Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)","url":"https://stock-news.laohu8.com/highlight/detail?id=2659293951","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2659293951?lang=en_us&edition=fundamental","pubTime":"2026-08-15 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23:19","pubTimestamp":1786634340,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/SRRK/analyst-ratings","market":"other","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":"2658987680","title":"Scholar Rock Holding Price Target Maintained with a $65.00/Share by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2658987680","media":"Dow 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Date","url":"https://stock-news.laohu8.com/highlight/detail?id=2658347984","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2658347984?lang=en_us&edition=fundamental","pubTime":"2026-08-10 17:19","pubTimestamp":1786353580,"startTime":"0","endTime":"0","summary":"(Updates with day of announcement in first paragraph, Novo Nordisk's affiliation in the second paragraph, and latest stock moves in the fourth paragraph.)Scholar Rock Holding (SRRK) said Friday that t","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["IBRN","THNR","BK4139","SRRK"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2657629325","title":"Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date","url":"https://stock-news.laohu8.com/highlight/detail?id=2657629325","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2657629325?lang=en_us&edition=fundamental","pubTime":"2026-08-08 04:46","pubTimestamp":1786135593,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, wit","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["SRRK","BK4139","IBRN","THNR"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2657629331","title":"Scholar Rock Holdings Pulls Novo Nordisk Facility from Drug Application After FDA Flag","url":"https://stock-news.laohu8.com/highlight/detail?id=2657629331","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2657629331?lang=en_us&edition=fundamental","pubTime":"2026-08-08 04:46","pubTimestamp":1786135560,"startTime":"0","endTime":"0","summary":"Scholar Rock Holding is removing one Novo Nordisk-owned fill-finish facility from its biologics license application for apitegromab to treat spinal muscular atrophy, after the facility was flagged for possible enforcement by the Food and Drug Administration.The biopharmaceutical company said the application will proceed with a second fill-finish facility -- a U.S.-based facility in good standing with the FDA and European regulators -- and is on track for potential FDA approval by Sept. 30.Scholar Rock said it received a customer notification on Friday that the FDA classified the first fill-finish facility, Novo Nordisk-owned Catalent Indiana, as Official Action Indicated following an April site inspection. The classification means that regulatory and/or administrative actions are recommended, according to the FDA.\"Scholar Rock will continue to collaborate closely with the FDA and under their guidance, will remove Catalent Indiana from the apitegromab BLA,\" the company said. \"FDA review","market":"other","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":["NVOX","BK4532","BK4585","IE00BKVL7J92.USD","THNR","SRRK","NVO","LU1093756325.SGD","BK4599","IBRN","BK4007","LU0154236417.USD","LU1093756168.USD","OZEM","NVOH","BK4588","IE00BZ1G4Q59.USD","BK4139","PPH"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2657072626","title":"Scholar Rock to remove Catalent Indiana facility from apitegromab BLA","url":"https://stock-news.laohu8.com/highlight/detail?id=2657072626","media":"TIPRANKS","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2657072626?lang=en_us&edition=fundamental","pubTime":"2026-08-08 04:30","pubTimestamp":1786134642,"startTime":"0","endTime":"0","summary":"Scholar Rock (SRRK) announced that the FDA review of the apitegromab biologics license application, or BLA, for the treatment of children and adult...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/scholar-rock-to-remove-catalent-indiana-facility-from-apitegromab-bla-thefly-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/scholar-rock-to-remove-catalent-indiana-facility-from-apitegromab-bla-thefly-news?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["LABU","THNR","BK4585","BK4139","IBRN","SRRK","BK4588"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2657260426","title":"Analysts Have Conflicting Sentiments on These Healthcare Companies: InMode (INMD), GH Research (GHRS) and Scholar Rock Holding (SRRK)","url":"https://stock-news.laohu8.com/highlight/detail?id=2657260426","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2657260426?lang=en_us&edition=fundamental","pubTime":"2026-08-08 04:30","pubTimestamp":1786134613,"startTime":"0","endTime":"0","summary":"Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on InMode (INMD), GH Research (GHRS) and Scholar Rock...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-inmode-inmd-gh-research-ghrs-and-scholar-rock-holding-srrk-blurbs-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-have-conflicting-sentiments-on-these-healthcare-companies-inmode-inmd-gh-research-ghrs-and-scholar-rock-holding-srrk-blurbs-news?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BK4588","GH","GDOC","INMD","XLV","BK4581","XBI","SRRK","HELX","LABU","BK4082","EKG","GNOM","BK4137","THNR","PTH","LU0889565916.HKD","LU0029874061.USD","LFSC","BK4139","BK4007","BK4551","BK4535","LU0109394709.USD","HCSG","GNMX","PSIL","IBRN","LU0128526141.USD","BK4196","GHRS","LU0320765992.SGD","BK4539","BK4585","FFOX"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":7,"pageCount":1,"totalSize":134,"code":"91000000","status":"200"}]}}