EBVALLO (Tabelecleucel (ATA 129)) - (ALLELE)

October 14, 2026: Atara Biotherapeutics (NASDAQ: ATRA) said partner Pierre Fabre Pharmaceuticals received FDA acceptance of the Biologics License Application resubmission for tabelecleucel (tab-cel) as monotherapy for adult and pediatric patients age 2 and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) after at least one prior therapy. The resubmission was classified as a Class 2 review, and the PDUFA target action date is March 31, 2027.

The release states tab-cel could become the first therapy available in the U.S. for EBV+ PTLD if approved. Tab-cel has FDA Breakthrough Therapy Designation for rituximab-refractory EBV-associated lymphoproliferative disease and orphan drug designation for EBV+ PTLD.

The company also disclosed regulatory risk remains, noting the resubmission follows a second complete response letter received on January 9, 2026, and that FDA could still extend review or issue another CRL. Under Atara’s commercialization agreement with Pierre Fabre, Atara would be eligible for a $31 million milestone payment upon approval, plus double-digit tiered royalties and additional sales milestones.