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19:31","pubTimestamp":1782127877,"startTime":"0","endTime":"0","summary":"Regenxbio aligned with the FDA on a path to resubmit the NAVSUNLI BLA for accelerated approval in Q3 2026.The FDA confirmed no additional studies or patient enrollment are required, reversing its earlier request for an untreated control arm.A Type A meeting is expected in July to review longer-term biomarker and clinical data from the CAMPSIITE study.The FDA plans an expedited review of the resubmission, with labeling discussions set to start shortly after filing.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. Regenxbio Inc. published the original content used to generate this news brief via PR Newswire  on June 22, 2026, and is solely responsible for the information contained therein.","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260622:nNDL3bx86:1","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":["BK4139","BK4505","RGNX","BK4563"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645960021","title":"Regenxbio Announces Alignment With FDA on Path Forward for Navsunli™ Bla Resubmission for Accelerated Approval; First Potential Gene Therapy for Mps Ii","url":"https://stock-news.laohu8.com/highlight/detail?id=2645960021","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645960021?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:30","pubTimestamp":1782127801,"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:20260622:nTUA9BHJ6Q: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":"reuters_en_live","symbols":["RGNX","BK4563","BK4505","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645021130","title":"Regenxbio - 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Spokerperson","url":"https://stock-news.laohu8.com/highlight/detail?id=2645021967","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645021967?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:29","pubTimestamp":1782127759,"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:20260622:nFWN42U05W: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":"reuters_en_live","symbols":["BK4139","BK4563","RGNX","BK4505"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645021808","title":"BUZZ-Regenxbio rises after report FDA to reverse rejection of rare-disease gene therapy","url":"https://stock-news.laohu8.com/highlight/detail?id=2645021808","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645021808?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:19","pubTimestamp":1782127186,"startTime":"0","endTime":"0","summary":"BUZZ-Regenxbio rises after report FDA to reverse rejection of rare-disease gene therapy** Shares of drug developer Regenxbio RGNX.O rise 7.8% to $8.41 premarket ** U.S. FDA to reverse rejection of RGNX's rare-disease gene therapy, Navsunli, Wall Street Journal reports** Co plans to refile its application in Q3 after a formal meeting with the FDA expected in July, the reports says ** FDA had rejected the initial application in February, citing concerns around the study and asking for a new trial with placebo patients** Reuters could not immediately reach Regenxbio for comment outside regular business hours ** As of last close, RGNX down 45.8% YTD   ","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:20260622:nL4N42U0R6:1","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":["BK4505","BK4563","RGNX","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645289029","title":"Regenxbio Shares Up on WSJ Report of FDA U-Turn on Company's Gene Therapy","url":"https://stock-news.laohu8.com/highlight/detail?id=2645289029","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645289029?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:04","pubTimestamp":1782126240,"startTime":"0","endTime":"0","summary":"Shares of Regenxbio gained after the Food and Drug Administration agreed to reverse its rejection of the biotech company's experimental gene therapy for a rare and fatal brain disease.Regenxbio's stock climbed 12% to $8.75 in premarket trading.The Wall Street Journal reported Monday that the company plans to refile its application for approval of its Navsunli gene therapy in the third quarter, after it holds a formal meeting to resolve disputes with the FDA that is expected in July.Regenxbio's Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient's midteens, the Journal reported.The disease affects about 2,000 people worldwide--nearly all boys--and about 50 people are diagnosed a year in the U.S., according to the Journal.","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":["BK4139","RGNX","BK4585","BK4563","BK4505","BK4588","LABU"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":9,"pageCount":4,"totalSize":178,"code":"91000000","status":"200"}]}}