Atara Biotherapeutics reports Pierre Fabre request for FDA Type A meeting on tabelecleucel

Reuters

Mar 03

<a href="https://laohu8.com/S/ATRA">Atara Biotherapeutics</a> reports Pierre Fabre request for FDA Type A meeting on tabelecleucel

Atara Biotherapeutics said its partner Pierre Fabre Pharmaceuticals has submitted a request to the U.S. FDA for a Type A meeting regarding tabelecleucel (tab-cel). The companies submitted a briefing book addressing items raised in the FDA’s Complete Response Letter dated Jan. 9, 2026, and provided additional context and clarification that the ALLELE study was “adequate, well-controlled, and sufficient” to support the tab-cel Biologics License Application. The briefing book also includes updated longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program, and post-marketing data in Europe intended for inclusion in a potential resubmission.

Disclaimer: This news brief was created by Public Technologies (PUBT) 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. Atara Biotherapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260303134105) on March 03, 2026, and is solely responsible for the information contained therein.

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Atara Biotherapeu","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","ATRA":"Atara Biotherapeutics"},"translate_title":"Atara Biotherapeutics报告Pierre Fabre请求FDA就tabelecleucel召开A型会议","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ATRA":0.9},"content_text":"Atara Biotherapeutics reports Pierre Fabre request for FDA Type A meeting on tabelecleucel\n    \n\n        Atara Biotherapeutics said its partner Pierre Fabre Pharmaceuticals has submitted a request to the U.S. FDA for a Type A meeting regarding tabelecleucel (tab-cel). The companies submitted a briefing book addressing items raised in the FDA’s Complete Response Letter dated Jan. 9, 2026, and provided additional context and clarification that the ALLELE study was “adequate, well-controlled, and sufficient” to support the tab-cel Biologics License Application. 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