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.
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