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The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter  for EBVALLO that was announced on January 16, 2025. While ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL. These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies  facility in Thousand Oaks, California. The FDB facility remains a critical component of Atara’s long-term manufacturing strategy for both assets.Atara","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://finance.yahoo.com/news/atara-biotherapeutics-provides-clinical-programs-123000959.html","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":"yahoofinance","symbols":["BK4530","ATRA","BK4588","BK4121","BK4139","CRL","BK4585","LU0390134368.USD"],"gpt_icon":0},{"id":"2504195429","title":"ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate","url":"https://stock-news.laohu8.com/highlight/detail?id=2504195429","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2504195429?lang=en_us&edition=fundamental","pubTime":"2025-01-17 22:24","pubTimestamp":1737123840,"startTime":"0","endTime":"0","summary":"Tab-cel, the company’s novel T-cell immunotherapy, is already marketed in the EU under the brand name, Ebvallo, by Atara’s partner Pierre Fabre under an exclusive commercialization and license agreement.EBV+ PTLD is a rare hematologic malignancy  with a high mortality rate and occurs after patients undergo transplantation when their T-cell immune responses are compromised by immunosuppression.In the past three months, Atara shares have lost 16.8% compared with the industry’s 12.2% decline.More on the FDA’s CRL Issuance Against ATRA’s Ebvallo. Atara is eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the Ebvallo BLA, providing a critical cash infusion for the company. Additionally, it will be eligible for substantial double-digit tiered royalties based on net sales and further milestones tied to Ebvallo's commercial performance. 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01:28","pubTimestamp":1737048489,"startTime":"0","endTime":"0","summary":"Shares of Atara Biotherapeutics  dropped 38.15% to $8.14 in trading Thursday at 12:14 p.m. ET after the company announced it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding its Biologics License Application for EBVALLO. The business said the letter included remarks from a pre-licensing examination of a third-party production facility but omitted any flaws pertaining to clinical effectiveness, safety data, or manufacturing technique. Atara pointed that the agency asked for no further clinical research.Atara also claimed it signed a non-binding term sheet with Redmile Group to use an equity line of credit to get up to $15 million in financing. According to the firm, this money is meant to sustain continuous operations needed for EBVALLO clearance. Atara also pointed out that should further funding not be obtained in the first quarter of 2025, its CAR-T research initiatives might be suspended. The introduction of the firm includes this material","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://finance.yahoo.com/news/atara-biotherapeutics-shares-plunge-38-172809561.html","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":"yahoofinance","symbols":["BK4139","ATRA"],"gpt_icon":0},{"id":"2504914581","title":"Atara Biotherapeutics Shares Tumble Amid 'Compliance Issues' Involving Manufacturing Plant for Ebvallo","url":"https://stock-news.laohu8.com/highlight/detail?id=2504914581","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2504914581?lang=en_us&edition=fundamental","pubTime":"2025-01-17 00:09","pubTimestamp":1737043798,"startTime":"0","endTime":"0","summary":"Atara Biotherapeutics (ATRA) shares were down more than 40% in Thursday trading after the company reported \"compliance issues\" involving a third-party manufacturing facility for Ebvallo, a treatment f","market":"hk","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":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4139","ATRA"],"gpt_icon":0},{"id":"2503915682","title":"US Stocks Edge Lower; Retail Sales Increase Less Than Expected","url":"https://stock-news.laohu8.com/highlight/detail?id=2503915682","media":"Benzinga","labels":["express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2503915682?lang=en_us&edition=fundamental","pubTime":"2025-01-16 23:07","pubTimestamp":1737040042,"startTime":"0","endTime":"0","summary":" ","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":"51810f2db92e53422bd679b0edc6a1cb","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.benzinga.com/25/01/43031061/us-stocks-edge-lower-retail-sales-increase-less-than-expected","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BMRA","WHLR","DATS","ATRA","LFLY","LUXH"],"gpt_icon":1},{"id":"2503990038","title":"Atara Biotherapeutics Shares Down 43.8% After US FDA Declines to Approve Co's Cancer Therapy","url":"https://stock-news.laohu8.com/highlight/detail?id=2503990038","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2503990038?lang=en_us&edition=fundamental","pubTime":"2025-01-16 22:34","pubTimestamp":1737038054,"startTime":"0","endTime":"0","summary":null,"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:20250116:nFWN3OC116:1","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","ATRA"],"gpt_icon":0},{"id":"2503997780","title":"FDA Rejects Atara's Request to Bring Blood Cancer Treatment to Market","url":"https://stock-news.laohu8.com/highlight/detail?id=2503997780","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2503997780?lang=en_us&edition=fundamental","pubTime":"2025-01-16 22:16","pubTimestamp":1737036960,"startTime":"0","endTime":"0","summary":"Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter.The biotechnology company said the Food and Drug Administration's notice was based on observations from an inspection of a third-party manufacturing facility, and that the agency did not spot deficiencies in the drug's manufacturing process or in the drug's efficacy or safety. Evballo targets a rare blood cancer that develops after transplants.Atara said it had received the complete response letter, which the FDA uses to indicate that the review cycle for an application has finished and that the application is not ready to be approved. Atara noted that the agency didn't ask for the company to conduct any new clinical trials. It said it will file for a resubmission and expects potential approval within six months of that resubmission.Atara also said it is continuing to review strategic alternatives, is in \"active discussions with","market":"hk","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":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","ATRA"],"gpt_icon":0}],"pageSize":16,"totalPage":6,"pageCount":3,"totalSize":91}]}}