Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration
Business Wire•14/10/2026•08:05 ET
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Key Highlights
- ➤FDA accepts resubmitted tabelecleucel BLA for EBV+ PTLD patients
- ➤PDUFA target action date set for March 31, 2027
- ➤Tab-cel could become the first U.S. therapy for EBV+ PTLD
- ➤Atara could receive a $31 million milestone upon FDA approval
Expert Statements
Cokey Nguyen, President and Chief Executive Officer of Atara Biotherapeutics
“The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S.”
Cokey Nguyen, President and Chief Executive Officer of Atara Biotherapeutics
“We appreciate the Agency’s guidance and look forward to a collaborative review process.”
Cokey Nguyen, President and Chief Executive Officer of Atara Biotherapeutics
“We will continue supporting PFP as it prepares for a potential U.S. launch.”
Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration
Prescription Drug User Fee Act (PDUFA) Target Action Date of March 31, 2027
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