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Atara Biotherapeutics Awaits FDA Decision on Tab-cel® BLA with PDUFA Target Date Set for January 10, 2026, Potential $40 Million Milestone from Pierre Fabre Laboratories

Reuters
08/12
<a href="https://laohu8.com/S/ATRA">Atara Biotherapeutics</a> Awaits FDA Decision on Tab-cel® BLA with PDUFA Target Date Set for January 10, 2026, Potential $40 Million Milestone from Pierre Fabre Laboratories

Atara Biotherapeutics Inc., a leader in T-cell immunotherapy, has announced a significant milestone in its ongoing regulatory review process. The company has set a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026, for its biologics license application $(BLA.AU)$ for Tabelecleucel (tab-cel® or Ebvallo™), aimed at treating Post-Transplant Lymphoproliferative Disease (PTLD). This regulatory milestone is crucial, as the approval of the BLA would trigger a $40 million milestone payment from Pierre Fabre Laboratories, enhancing Atara's financial flexibility significantly. Additionally, Atara has transferred most operational activities related to tab-cel to Pierre Fabre Laboratories. The company is also evaluating strategic options, including potential acquisitions or mergers, following the resubmission of the tab-cel BLA.

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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0000950170-25-106533), on August 11, 2025, and is solely responsible for the information contained therein.

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